CME Objectives: Older patients with distal symmetric polyneuropathy (DSP) are at markedly increased risk for falls and fall-related injuries. Few studies have investigated the effect of exercise regimens on gait and balance in this high-risk group. This activity is designed to increase physician competence in the treatment of older patients with DSP. Upon completion of the article, the reader should be able to: (1) Describe common gait abnormalities seen in individuals with peripheral neuropathy, (2) Identify the most important sensory inputs for maintenance of balance and walking, and (3) Distinguish between the effect of Tai Chi versus Functional Balance Training on selected clinical outcomes and measures of gait.

Level: Advanced Accreditation: The Association of Academic Physiatrists is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The Association of Academic Physiatrists designates this activity for a maximum of 1.5 AMA PRA Category 1 Credit(s). Physicians should only claim credit commensurate with the extent of their participation in the activity.

Authors: Patricia A. Quigley, PhD, ARNP, CRRN, FAAN, FAANP Tatjana Bulat, MD Brian Schulz, PhD Yvonne Friedman, MA, OTR/L, CCRC Stephanie Hart-Hughes, MSMS, PT, NCS James K. Richardson, MD Scott Barnett, PhD

Affiliations: From the VISN 8 Patient Safety Center of Inquiry, James A. Haley Veterans Hospital, Tampa, Florida (PAQ, TB, YF, SH-H); Department of Veterans Affairs, Washington, DC (BS); Department of Physical Medicine and Rehabilitation, University of Michigan Health Systems, Ann Arbor (JKR); and Health Services Research & Development, Center of Innovation and Disability Rehabilitation Research, James A. Haley Veterans Hospital, Tampa, Florida (SB).

Correspondence: All correspondence and requests for reprints should be addressed to: Patricia A. Quigley, PhD, ARNP, CRRN, FAAN, FAANP, VISN 8 Patient Safety Center of Inquiry, 8900 Grand Oaks Circle, Tampa, FL 33637. 0894-9115/14/9301-0001 American Journal of Physical Medicine & Rehabilitation Copyright * 2013 by Lippincott Williams & Wilkins DOI: 10.1097/PHM.0000000000000052

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Exercise

CME ARTICLE

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2014 SERIES

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NUMBER 1

Exercise Interventions, Gait, and Balance in Older Subjects with Distal Symmetric Polyneuropathy A Three-Group Randomized Clinical Trial ABSTRACT Quigley PA, Bulat T, Schulz B, Friedman Y, Hart-Hughes S, Richardson JK, Barnett S: Exercise interventions, gait, and balance in older subjects with distal symmetric polyneuropathy: A three-group randomized clinical trial. Am J Phys Med Rehabil 2014;93:1Y16.

Objective: Older patients with a distal symmetric polyneuropathy are at markedly increase risk for falls and fall-related injuries. Despite this, few studies have investigated the effect of exercise regimens on gait and balance in this high-risk group.

Design: One hundred older patients with distal symmetric polyneuropathy were randomized to one of three interventions: functional balance training, Tai Chi, or education-only control. The subjects in each group received instruction in ten 1-hr weekly sessions. Outcome measures were determined at baseline and the end of the 10-wk intervention. Gait, balance, and falls self-efficacy were assessed with various well established clinical (Berg Balance Scale, 8 Foot Up and Go Test, and Modified Falls Efficacy Scale) and laboratory-based measures (three-dimensional gait analysis and NeuroCom limits of stability and sensory organization tests).

Results: The Tai Chi subjects demonstrated a decreased (faster) Timed Up and Go and increased stride length and time spent in single limb support at the end of intervention as compared with baseline. The functional balance training group demonstrated a significant increase in ankle plantar flexor power and near significant decreases in step width and step width variability. No changes in the education-only control group were observed.

Conclusions: Older patients with distal symmetric polyneuropathy may benefit from Tai Chi and/or functional balance training, with the former improving functional mobility and gait and the latter possibly improving trunk stabilization and forward progression (Lythgo N, Cofre´ LE: Relationship between ankle plantar flexor power and EMG muscle activity during gait. 30th Annual Conference of Biomechanics in Sports [Melbourne, 2012]. Available at: https://ojs.ub.uni-konstanz.de/cap/article/ viewFile/5320/4891). Whether these laudable changes can be maintained or translate into decreased risk for falls and fall-related injuries is unknown. Key Words: Balance, Group Exercise, Gait, Peripheral Neuropathy, Outcomes, Rehabilitation, Tai Chi, Clinical Trial

Exercise in Distal Symmetric Polyneuropathy Copyright © 2013 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

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Disclosures: Supported by the Office of Research and Development, Rehabilitation Research and Development Service Study no. O4006RA, Department of Veterans Affairs, James A. Haley VA Hospital, and the VISN 8 Patient Safety Center of Inquiry. Financial disclosure statements have been obtained, and no conflicts of interest have been reported by the authors or by any individuals in control of the content of this article.

F

alls are destructive forces that exact harsh physical1 and psychosocial2 tolls on older persons and demand significant resources from society.3 Impairments in gait and balance not only cause falls but are a consequence of them.4 Evidence suggests that exercise programs can effectively improve gait and balance in unselected fall risk populations and reduce falls and fall-related injuries.5,6 Exercise interventions come in various forms, but the most common are functional balance training (FBT) and Tai Chi (TC).7,8 FBT combines muscle strengthening, balance, and functional gait activities, and clinical trials suggest that this form of intervention can reduce fall risk.9Y11 TC primarily involves learning routines of motion that are typically performed slowly in a manner that progressively challenges dynamic balance. This technique has been found to decrease fall risk in a large unselected populationbased study.5,12 Accurate visual, vestibular, and somatosensory information is necessary to reliably maintain balance during standing and walking. Experimental manipulations suggest that, of these, somatosensory information of the hip and the ankle is of greatest importance.13,14 Accordingly, a distal symmetric polyneuropathy (DSP), which diminishes distal somatosensory input from the feet and the ankles,15 has been found to impair standing balance and to retard recovery from perturbations.16Y20 Moreover, DSP is associated with impairments in rapidly generated or high-velocity motor function in the distal lower limb, even in the setting of clinically normal strength.20,21 These distal afferent and efferent impairments both seem to contribute significantly to postural instability in persons with DSP.15,20 Individuals with DSP demonstrate gait abnormalities such as increased step width and step time variabilities, decreased velocity and step length, and increased step time and time spent in dual support22Y24 and are at a markedly increased risk for falls and fall-related injuries.25Y27 Recent studies found that gait speed was explained best by frontal plane motor function at the hip and

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ankle E, F, G and gait speed, and efficiency on uneven surfaces was predicted by lower limb sensorimotor functions.28Y30 Augmenting the clinical relevance of these findings, DSP is common among older persons with increasing risk for falls.31 Epidemiologic studies suggest that the prevalence of diabetes mellitus and impaired glucose tolerance is increasing and affects more than 40% of American citizens in the 60- to 74-yr age group.32 Other work indicates that the prevalence of DSP in this age group is between 32% and 50% for persons with diabetes mellitus, 11% for persons with impaired glucose tolerance, and 7.2% for normoglycemic persons.33 Taken together, these data suggest that the prevalence of polyneuropathy (PN) in the 60- to 74-yr age group is approaching 20%, with the majority caused by diabetes. The few studies focusing exclusively on subjects with DSP have been hindered by small sample size, single-blind design,34 and minimal effect.35 Therefore, a randomized controlled clinical trial was performed, evaluating the effect of FBT and TC on measures of balance, gait, and fall selfefficacy in a group of older veterans with DSP. The purpose of the trial was to improve successful adaptation to aging and quality-of-life in veterans with DSP. The specific hypothesis was that compared with an education-only control group (EC), a once-a-week program for 10 wks in TC or FBT would improve clinical assessments, gait, and balance.

METHODS Overview of Study Design Study Design This study was approved by the University of South Florida institutional review board, and all subjects provided written informed consent. This study was designed as a parallel, three-group, randomized controlled trial. Data were collected at four different times: baseline, immediate postintervention (10 wks), 3 mos, and 6 mos. The intervention (FBT and TC) and EC groups consisted of ten 1-hr weekly sessions. The intervention dose was chosen on the basis of previous clinical experience by the study team with the population being investigated and past challenges implementing interventions, which required several patient visits per week. Past experience has demonstrated the need to minimize patient travel burden both caused by driving distance and the elevated price of gas. Although it was conceded that this reduced dose could have influenced the study results, there was a need to prioritize a reduced travel burden for the subjects. This was mitigated by emphasizing

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the home exercise component of the training, which was tracked with a daily exercise log. The project manager randomized the eligible subjects to one of the three groups using a computer-generated randomization schedule; only the statistician possessed the key. At the end of baseline data collection, the patients were handed a sealed envelope with their study group assignment. Project staff members measuring outcomes were blinded to the group assignment. Subjects The subjects were recruited through informational fliers; public advertising by radio; and preplanned study displays throughout the Tampa Veterans Administration Hospital and Clinics, University of South Florida Neurology Clinics, and Bay Pines Veterans Administration Diabetes Clinics. Interested subjects, or their representatives, spoke to the project manager and were scheduled for enrollment. At the initial screening visit, a project manager and physician completed both the medical record review and physical examination and subsequently completed the subject interview to determine eligibility. Specific inclusion criteria were as follows: able to read and follow three-step instructions, older than 18 yrs, able to ambulate household distances with or without an assistive device, symptoms consistent with DSP (reports of symmetric, distal lower limb numbness or altered sensation), and signs consistent with PN (Michigan Diabetic Neuropathy Scale Q7). No specific calculations of hip abductor/adductors or ankle inversion/ eversion were included in the inclusion/exclusion requirement or subject data collection. Rather, as-

sessment of the lower extremity included manual muscle and neurologic examination. Exclusion criteria were cognitive impairment (MiniYMental State Examination score G 24), severe disease such as metastatic cancer, central neurologic dysfunction as determined by medical record review or physical examination, any lower limb amputation, lower limb motor weakness that was less than antigravity (e.g., loss of dorsiflexion strength leading to foot drop with motor strength of less than 3/5), mobility limitations caused by altered lower extremity skin integrity/ulcer, and medically unstable condition (e.g., uncontrolled hypertension, dyspnea at rest or with minimal exertion, unstable angina). After informed consent and randomization, each subject was provided a study calendar with scheduled group sessions and reassessment visits. Incentives for subject enrollment and retention included a $10.00 prepaid gasoline card for each session, bottled water, and healthy snacks after each session. Additional demographic data were collected on the basis of study protocol after informed consent (Table 1). The subjects were given reminder calls before each group session and testing visit to improve retention.

Study Groups and Procedures General After randomization, the subjects attended a weekly, 1-hrYlong session for 10 wks. Two trained mobility assistants were present for all exercise groups to ensure safety of the subjects. All participants received a handout each week with weekly homework assignments. The homework assignments were generally a single activity assigned during group

TABLE 1 Demographic characteristics

Age, yrs Female Body mass index Education Some school HS diploma/GE Some college College degree White Self-described as active Michigan Diabetic Neuropathy Score No. fall-related medications No. comorbidities Attendance in sessions

P

EC (n = 31)

TC (n = 34)

FBT (n = 34)

67.5 (10.2) 25 (80.7) 30.3 T 6.0

68.4 (9.3) 29 (85.3) 30.4 T 5.3

67.6 (10.6) 30 (88.2) 29.2 T 4.5

0.923 0.693 0.587

6 (19.4) 5 (16.1) 12 (38.7) 8 (25.8) 26 (83.8) 20 (64.5) 14.6 T 5.4 1.4 T 1.5 10.1 T 5.4 5.7 T 3.7

12 (35.3) 1 (2.9) 17 (50.0) 4 (11.8) 30 (88.2) 19 (55.9) 16.0 T 5.6 1.1 T 1.1 7.9 T 4.2 5.5 (3.9)

14 (41.2) 2 (5.9) 12 (35.3) 6 (17.7) 25 (73.5) 20 (58.8) 16.1 T 5.4 1.0 T 1.3 8.0 T 4.8 5.9 T 4.1

V V V 0.170 0.273 0.773 0.475 0.444 0.124 0.915

Values are expressed as mean T standard deviation or frequency and percentage. HS, high school.

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sessions. Before beginning each weekly session, the class facilitator reviewed the homework progress for the week and the previous week’s class content.

Functional Balance Training FBT was led by a physical therapist and included strengthening, coordination, multitasking, hand-eye coordination, visual-perceptual conflict, and compensatory exercises. The primary goal of each class corresponded to an element of FBT. These elements increased in difficulty during the 10-wk class period, with standing and walking balance being the primary goal of class 1, progressing through various levels of mobility and postural control, and ending with multitasking and complex movement coordination. Each class consisted of a light warm-up with one flexibility exercise and one functional strength exercise before the initiation of balance maneuvers. This training program was modified in length (8Y10 wks) from the FBT program previously described in the literature.11

Tai Chi Classes were taught by a TC instructor. Each class consisted of a 10-min warm-up period, a 45-min supervised exercise session that included slow movements, unilateral to bilateral body weight shifting, and trunk motion rotations and a 5-min cooldown period. The instructor closely monitored exercise intensity so that all subjects maintained an approximately equal activity level. The intensity of exercise did not increase during the 10-wk period. All study participants were provided with a TC video for their home practice sessions, along with an instruction manual for each of the TC movements. During the 10 wks, the TC classes progressed to include 22 commonly known TC positions.

Education-Only Control Classes of the EC group were coordinated by a clinical pharmacist who specialized in falls and aging and were taught by a multidisciplinary team (i.e., vision screening and health, hearing screening and health, nutrition). The subjects were given homework assignments, but no exercises were conducted during these classes. The classes consisted of general health-related course content for each week: (1) medication safety, (2) nutrition, (3) home safety, (4) injury prevention, (5) health maintenance strategies, (6) osteoporosis prevention, (7) general fitness strategies, (8) how and what to report to your doctor, (9) vision screening and health, and (10) hearing screening and health.

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Outcome Measures Balance Berg Balance Scale. The Berg Balance Scale36 is a commonly used clinical, performance-based measure designed to evaluate performance during various balance activities in community-dwelling and institutionalized older adults. The scale includes 14 separate activities ranging from chair sitto-stand test to standing on one leg. 8 Foot Up and Go Test. The 8 Foot Up and Go Test37 is a test of functional mobility that requires the subject to arise from a sitting position, walk 8 ft and turn 180 degrees around a cone, and return to sitting. Two trials were completed (at baseline and 10 wks), and the faster time was used for analysis. Modified Falls Efficacy Scale. The Modified Falls Efficacy Scale assesses a patient’s self-reported ability to perform without falling each of 14 common activities of daily living in a Likert scale format.38 Items include ten indoor activities (e.g., get dressed and undressed, walk around inside your house) and four outdoor activities (e.g., simple shopping, using public transportation).

Gait Laboratory Shoes. Shoes were worn during the gait testing to protect the subjects’ feet. To minimize variation, the subjects wore standardized shoes (Apex Ambulator, Apex Shoes) in the appropriate size. To familiarize themselves with the shoes, the subjects were allowed to walk in the shoes before data collection. Instrumentation. A six-camera Vicon 460 3D Motion Analysis System (OMG plc, Denver, CO) was used to collect and process all kinematic and kinetic gait data using the Plug-in-Gait marker set and model.39 Three force plates recessed into a 38-ftYlong walkway were used to collect ground reaction force data. Toe and heel marker kinematics during ground contact events from exemplar force plate contacts were used to determine ground contact events for steps without force plate data using the Vaquita Event Handling Plug-Ins (Vaquita, Zaragoza, Spain). Gait kinematics were then extracted from the Plug-in-Gait output using the Vaquita Parameter Generator Plug-In. The Plug-in-Gait module was then used to calculate gait kinetics using established and validated algorithms. Walking Procedure. The study subjects were instructed to walk at their usual speed. The subjects performed a practice trial to ensure that all instrumentation was secure and instructions were understood. The subjects performed at least ten

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trials. If three steps with good kinetic data (clean force plate strikes) for each foot had not been collected during these trials, then additional trials were recorded until this criterion was met or subject fatigue (as per self-report or experimenter observation) or alterations in gait were evident. Variables. Spatiotemporal gait variables include gait velocity, step time, step time variability, step width, step width variability, stride time, stride length, and percentage of gait cycle spent in single limb support. These variables were selected because increased gait variability and slower, wider, and shorter steps have been associated with impaired gait and fall risk. Kinetic gait variables included peak plantar flexion power and peak ground reaction forces in the anterior, posterior, and vertical directions. Balance. Limits of stability (LOSs) and sensory organization tests were performed on a SMART Balance Master (NeuroCom International, Clackamas,

OR). The standard device protocols, which have been previously described, were used.40,41 All balance data collectors were trained on the subject setup procedures on the NeuroCom. Retest reliability has been shown to be good to excellent for both of these tests.42,43 Limits of stability. This test40 allows for the analysis of a subject’s ability to voluntarily move his/ her center of gravity to his/her LOSs in eight directions (front, back, sides, and diagonals). The outcomes calculated for this test are reaction time, sway velocity, directional control, endpoint excursion, and maximum excursion. These outcomes are calculated in each direction but are reported here as mean values across all directions. Endpoint excursion and maximum excursion are calculated as percentages of the subject’s theoretical 100% LOS that is a function of his/her height. Sensory organization test. The protocol42 allows for the detailed assessment of the three sensory

FIGURE 1 Recruitment and retention. MDNS, Michigan Diabetic Neuropathy Score. www.ajpmr.com

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Percent change from baseline was calculated as (post j pre)/pre scores. P value, overall one-way ANOVA test of null hypothesis of no statistically significant difference between the groups. a P G 0.05, post hoc test comparing the groups TC vs. EC. b P G 0.05, post hoc test comparing the groups FBT vs. EC. c P G 0.05, post hoc test comparing the groups TC vs. FBT. mFES, Modified Falls Efficacy Scale.

0.90a,b,c 113.7 T 32.3 119.6 T 24.6 123.1 T 27.3 121.5 T 19.9 120.6 T 18.6

0.75

118.8 T 27.2

3.62

j4.93

0.02a,b,c 8.7 T 4.6 8.7 T 4.9 8.3 T 2.0 8.7 T 3.4 9.0 T 4.0

j3.33

9.2 T 3.3

j9.78

0.00

0.99a,b,c 51.2 T 7.0 51.4 T 6.8 52.3 T 3.3 51.3 T 5.4 51.4 T 4.8

Berg (balance) (0Y56 range) 8 Foot Up and Go mFES (0Y140 range)

Outcome (Interval)

10 wks (n = 19)

j0.19

51.5 T 4.7

1.55

j0.39

P 10 wks (n = 19) Baseline (n = 34) 10 wks (n = 16)

% Change

% Change

Quigley et al.

Baseline (n = 33)

% Change

Baseline (n = 34)

FBT (n = 34) TC (n = 34) EC (n = 31)

TABLE 2 Clinical assessments

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systems responsible for balance: vision, somatosensory, and vestibular input. Only the composite score across all test conditions is reported.

Sample Size Our pilot data suggested mean T SD differences in Berg Balance Scale scores of 6.48 T 3.03 and 8.0 T 9.20 in LOS tests. For this project, sample size was chosen to provide at least 80% power to detect Cohen effect size midway between middle and small (R2 = 0.07) using one-way analysis of variance (ANOVA), testing mean differences between the groups. Power analyses conducted using Cohen methods and conventions using the Power Analysis and Sample Size software44 showed that 135 subjects were required. The authors increased the desired sample size to 162 subjects (54 per group), assuming 20% attrition rate similar to their pilot work. Subject recruitment was concluded because of the end of grant funding.

Randomization Randomization sequence was created using the SAS 9.1 (Cary, NC) statistical software, with the subjects equally likely to be assigned to a group with a 1:1:1 allocation.

Statistical Analysis Demographic and outcome data are presented as mean T SD or frequency and percentage, where appropriate. Gait and balance measures are presented as change from baseline to 10 wksVdefined as (10-wk scores j baseline)/baseline and expressed as percentage. Outcome measures were normally distributed, and thus, parametric statistics were used for initial group comparisons using one-way ANOVA models or Pearson W2 test. Composite sensory organization test scores were used in the analysis, in addition to composite scores on the five subcomponents of the LOSs (i.e., movement velocity, directional control, endpoint excursion, maximal excursion, reaction time). The primary endpoint was change from baseline to 10 wks in gait and balance measures and assessed using separate one-way ANOVAs to test for statistically significant differences between the groups. Initial one-way ANOVA models were conducted, testing the null hypothesis that no statistically significant difference exists between any of three groups, with subsequent post hoc analyses conducted to determine whether the TC group or the FBT group differed from the EC group. Post hoc testing was accomplished via Bonferroni tests Am. J. Phys. Med. Rehabil. & Vol. 93, No. 1, January 2014

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10 wks (n = 19) 0.9 T 0.2 0.6 T 0.04 0.03 T 0.01 153.6 T 28.9 32.0 T 8.4 1.2 T 0.1 121.7 T 17.4 33.9 T 2.2 2.1 T 0.9 132.1 T 31.5 140.1 T 33.2 1080.4 T 172.1

Baseline (n = 33)

0.9 T 0.2 0.6 T 0.05 0.02 T 0.01

148.8 T 31.3 31.2 T 10.5

1.2 T 0.11 123.5 T 22.9 33.8 T 2.1

2.2 T 0.8

147.0 T 40.1

154.6 T 38.3

1084.3 T 165.0

1.2 T 0.2 116.3 T 24.4 32.5 T 3.3 1.9 T 0.7 126.7 T 42.8 141.0 T 48.2 1061.3 T 237.4

j4.55 j10.14 j9.38 j0.36

156.0 T 33.7 31.6 T 1.5

0.9 T 0.2 0.6 T 0.1 0.03 T 0.03

Baseline (n = 34)

0.00 j1.46 0.30

3.23 2.56

0.00 0.00 50.00

% Change

1021.3 T 203.6

135.9 T 44.4

124.3 T 44.8

2.1 T 1.0

1.2 T 0.1 123.1 T 22.0 34.6 T 2.4

153.1 T 32.2 31.2 T 9.3

0.9 T 0.2 0.6 T 0.05 0.03 T 0.01

10 wks (n = 16)

TC (n = 34)

j3.77

j3.62

j1.89

10.53

1051.9 T 174.2

140.2 T 32.0

132.1 T 37.0

1.9 T 0.5

1.2 T 0.1 123.8 T 19.5 33.7 T 2.2

145.2 T 34.3 31.4 T 0.5

j1.86 j1.27 0.00 5.85 6.46

0.90 T 0.2 0.6 T 0.06 0.02 T 0.01

Baseline (n = 34)

0.00 0.00 0.00

% Change

1008.4 T 176.5

122.7 T 35.6

118.7 T 34.0

2.1 T 0.5

1.2 T 0.2 115.9 T 22.8 32.7 T 3.1

134.7 T 32.1 29.4 T 6.7

0.90 T 0.2 0.6 T 0.08 0.04 T 0.03

10 wks (n = 19)

FBT (n = 34)

j4.14

j12.48

j10.14

10.53

0.00 j6.38 j2.97

j7.23 j6.37

0.00 0.00 100.00

% Change

Percent change from baseline was calculated as (post j pre)/pre scores. P value, overall one-way ANOVA test of null hypothesis of no statistically significant difference between the groups. a P G 0.05, post hoc test comparing the groups TC vs. EC. b P G 0.05, post hoc test comparing the groups FBT vs. EC. c P G 0.05, post hoc test comparing the groups TC vs. FBT.

Velocity, m/sec Step time, secs Step time variability, secs Step width, mm Step width variability, mm Stride time, secs Stride length, cm Time spentYsingle limb support (% gait cycle) Peak ankle plantar flexion power, W/kg Peak ground reaction forceYanterior, N Peak ground reaction forceYposterior, N Peak ground reaction forceYvertical, N

Outcome/Group

EC (n = 31)

TABLE 3 Quantified measurements of gait

0.05a,b

0.28a,b,c

0.09a,c

0.03a,b

0.15 0.03a,b,c 0.01a,b,c

007a,b,c 0.07a,b,c

0.69 0.17 0.22a,b,c

P

Modified Falls Efficacy Scale There were no significant changes in the Modified Falls Efficacy Scale after intervention as compared with baseline for any of the groups.

Quantified Measurements of Gait and Balance Gait The TC group demonstrated increased single limb support time and stride length after intervention (Table 3). These variables were unchanged in the other two intervention groups. The FBT

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0.800a,b,c 0.800a,c 0.110a,b,c 0.110b,c 0.110a,b,c 0.190a,b,c 4.3 j10.0 10.1 11.1 15.9 18.5 72.1 T 9.5 0.9 T 0.3 77.6 T 11.5 3.2 T 1.0 59.8 T 10.9 72.4 T 12.5 15.7 0.3 16.7 0.9 14.9 18.8 69.1 T 1.0 T 70.5 T 2.7 T 51.6 T 61.1 T 2.2 0.0 4.1 j3.8 6.6 8.9 7.9 0.3 16.0 0.6 12.3 8.7 69.7 T 1.0 T 71.8 T 2.5 T 53.3 T 72.0 T 68.2 T 14.2 1.0 T 0.3 69.0 T 14.9 2.6 T 1.0 50.0 T 13.0 66.1 T 15.2 j2.1 j10.0 j0.7 j3.3 j3.2 14.0

Reaction time is the time in seconds between the command to move and the patient’s first movement. Maximum excursion is the maximum distance achieved during the trial. Movement velocity is the average speed of COG movement in degrees per second. Endpoint excursion is the distance of the first movement toward the designated target, expressed as the percentage of maximum LOS distance. The endpoint is considered to be the point at which the initial movement toward the target ceases. Percent change from baseline was calculated as (post j pre)/pre scores. P value, overall one-way ANOVA test of null hypothesis of no statistically significant difference between the groups. a P G 0.05, post hoc test comparing the groups TC vs. EC. b P G 0.05, post hoc test comparing the groups FBT vs. EC. c P G 0.05, post hoc test comparing the groups TC vs. FBT.

Although there was no change in the Timed Up and Go for the EC and FB groups, the TC group demonstrated a significant decrease in the Timed Up and Go (shorter time and therefore faster execution) after intervention as compared with baseline.

TABLE 4 Quantified measurements of balance

8 Foot Up and Go Test

EC (n = 31)

Berg Balance Scale There were no significant postintervention changes in the Berg Balance Scale scores (Table 2).

15.7 0.3 20.6 1.1 17.5 13.2

Assessments of Gait and Balance

70.4 T 0.9 T 75.2 T 2.9 T 54.7 T 70.1 T

TC (n = 34)

FBT (n = 34)

A total of 371 subjects responded to the study information, and 100 were randomized and completed the assigned intervention through 10 wks (Fig. 1). Subjects were not included for a variety of reasons including not meeting the study criteria, difficulty with transportation, and inability to attend sessions for the length of the study without interruption. As seen in Table 1, the study subjects were older adults, predominantly men, white, and overweight. Comorbidities were counted on the basis of medical diagnoses reported by the subject (nonYVeterans Affairs) or listed in the medical record, as an indicator of health status. There were no group differences in these basic demographics, health status, or medications commonly associated with postural instability and falls. On average, the subjects attended at least five of the ten study group sessions across all groups. Of 100 study subjects, 47 dropped out by 3 mos; and 68, by 6 mos (see Fig. 1 for the reasons for dropout). No difference in demographic characteristics between the subjects dropping out of the study and those completing it was identified (Table 1).

71.9 T 10.7 1.0 T 0.3 75.7 T 18.2 3.0 T 1.6 56.5 T 16.1 61.5 T 15.6

Subjects Characteristics and Compliance

Baseline (n = 33) 10 wks (n = 19) % Change Baseline (n = 34) 10 wks (n = 16) % Change Baseline (n = 34) 10 wks (n = 19) % Change P

RESULTS

Composite: directional control Composite reaction time Composite: maximum excursion Composite movement velocity Composite: endpoint excursion Sensory organization test

for multiple comparisons. Significance was set a priori at 0.05.

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group showed a significant increase in peak ankle plantar flexion power and trends toward increases in peak anterior and posterior ground reaction forces after the intervention. The FBT group also demonstrated a trend toward decreasing step width and step width variability after intervention. Balance There were no significant differences in LOS composite scores or sensory organization test scores for any group after intervention as compared with baseline (Table 4).

DISCUSSION The main findings related to this study are that the TC group demonstrated improved quantified gait measures, including increased stride length and increased time spent in single limb support, at the end of intervention. These findings suggest that the TC intervention decreased the effect of PN on gait, at least temporarily, because older persons with PN are known to walk with a Bshuffling[ gait characterized by shortened step length and increased time in double support as compared with those without PN.22,45 The TC group also showed a decrease in the Timed Up and Go, indicating that they performed it faster after the intervention. The significance of this finding, although not statistical, may be clinical because the decrease in Timed Up and Go time (9.2 T 3.3 secs vs. 8.3 T 2.0 secs for preintervention and postintervention, respectively) was sufficient for the subjects to move below the cutoff used clinically as a marker of increased fall risk (98.5 secs).41 The absence of any intervention effect on the clinical measures of balance may reflect a ceiling effect because the subjects were all near the maximal score of 56 on the Berg Balance Scale score before intervention. The absence of an effect on the quantified measure of balance may be related to this test simply being a precise measure of standing balance, which was not targeted by the interventions. This may be of diminished clinical importance given that most falls in older persons in general, and older persons with DSP, occur while walking.41,45 There were other findings that may be of potential clinical relevance. The FBT group demonstrated near significant decreases in step width and step width variability, as well as a significant increase in ankle plantar flexion power. Control of step width is the most efficient way to maintain frontal plane balance,46 and frontal plane balance is critical given the high fracture potential of lateral falls.47 It may be that the functional strength training was more efwww.ajpmr.com

fective at increasing the strength of the muscles necessary for frontal plane control at the hip and the ankle (hip abductor/adductors and ankle invertors/ evertors) and ankle plantar flexion power than was the TC intervention. Moreover, lower limb power has been shown to be more strongly correlated with lower limb function than strength among older persons.48 Given the importance of frontal plane control and lower limb power, a combination of TC and FBT may be the optimal intervention, with the former improving step length, functional gait speed, and time in single limb support and the latter improving frontal plane control. Although a variety of studies have investigated the effects of exercise on gait and balance among older persons, the authors are aware of few other studies that targeted persons with DSP. One of these49 described a very brief intervention (3 wks) for subjects with electrodiagnostically confirmed DSP and used only clinical outcomes (unipedal balance time, tandem stance time, and functional reach). This was of concern given that these outcomes are subject to bias and the evaluator of outcomes was not blinded to subject study group assignment. Therefore, although the study was randomized and an equivalent intervention was provided to control subjects, the nature of the outcome measures, the relatively small numbers of subjects, and the single-blind design weaken the results. The other study that targeted older persons with DSP had a larger number of subjects (930 in the intervention and control groups), was randomized, and had the evaluators of outcomes blinded to subject study group assignment. Furthermore, outcomes were both high technology and clinical in nature. However, the presence or the absence of DSP was identified by means of a single quantified measure of vibration, and the control group received no attention or intervention, sham or otherwise. The authors report laudable changes in the intervention group subjects’ quantified gait measures on smooth surfaces and cobblestones50 and also improvements in balance, performance mobility, confidence, and hip and ankle plantar flexion strength.34 The interventions were functional strength training and included twice-weekly 60-min sessions for 12 wks. The control group, however, received no intervention. Therefore, despite the study’s many strengths, the absence of an intervention for the control group and the determination of the presence/absence of DSP by the use of a single sensory modality weaken the strength of the conclusions. Most recently, a randomized controlled trial evaluating falls and balance outcomes was conducted in patients with diabetic peripheral neuropathy.51 In Exercise in Distal Symmetric Polyneuropathy

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that study, an exercise intervention (leg strengthening, balance exercises, and graduated walking program) was compared with control (motivational telephone calls). There were no significant differences in strength, balance, or participant-reported falls for the year after the enrollment. At 12 mos, there was a small increase in the amount of time that participants in the intervention group could stand on one leg with their eyes closed. The authors concluded that the intensity of intervention was insufficient to improve the strength and balance in this population; on a positive note, the increased activity in the intervention group did not increase the rate of falling when compared with the control group. However, of interest in this study is the examination of a new treatment approach for this study population, groupbased TC. The study reported here was designed to be a large-scale three-group randomized controlled trial to target older subjects with DSP but was underpowered because of attrition. The three groups were randomized, received equivalent time and attention during each session (1 hr) from the study personnel, and had evaluators of outcomes who were blinded to study group assignment. DSP was identified using the Michigan Diabetic Neuropathy Score, which requires the semiquantitative evaluation of distal strength, reflexes, and sensation. This technique is less than the criterion standard, which includes the use of electrodiagnostic studies along with physical findings52; however, because the Michigan Diabetic Neuropathy Score uses multiple evaluation techniques and is supported by previous work in older persons,35 few subjects were likely misclassified. Therefore, although the findings from this study were relatively modest in terms of benefit from the interventions, the findings are incrementally credible given the study design. The strength of the conclusions must be tempered by the study’s limitations. Gait changes associated with the interventions are laudable because these are counter to the usual gait abnormalities associated with DSP. However, whether these changes translate into increased mobility and/or a reduction in falls for neuropathic patients in the community is unknown. Moreover, because of subject dropout after 10 wks, the maintenance of these gait changes beyond this time is uncertain. Lastly, given the high attrition at months 3 and 6, only 54 subjects completed (49.5%) all follow-up. Thus, the final analyzable sample was not sufficiently powered to answer the proposed hypotheses and provide generalizable conclusions. The primary reported reason for not attending sessions or dropping out of

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the study was listed as Bunknown[; thus, the authors could provide no post hoc analysis of attrition trends to examine dropout rates across the groups. In summary, this randomized controlled study of older persons with DSP found that a 10-wk intervention of TC improves step length and time spent in single limb support during gait and increases gait speed during a functional task. Further, FBT improves frontal plane balance during gait, a finding of clinical relevance given the malignant outcomes associated with lateral falls. A combination of both FBT and TC interventions may allow improvement in all of these domains and may be the optimal intervention for this high-risk population.

REFERENCES 1. Rubenstein LZ, Josephson KR: The epidemiology of falls and syncope. Clin Geriatr Med 2002;18:141Y8 2. Dunn JR, Rudberg MA, Furner SE, et al: Mortality, disability and falls in older persons: The role of underlying disease and disability. Am J Public Health 1992;82:1263Y7 3. Hawryluk M: Fall-related injuries cost Medicare billions. American Medical News 2002;5Y8 4. Foster E, Hillegass LJ, Phillips SL: Demonstration program: An interdisciplinary approach at a Falls and Mobility Clinic. Ann Long Term Care 2004;12:27Y32 5. Herwaldt L, Pottinger J: Preventing falls in the elderly. J Am Geriatr Soc 2003;51:1175Y7 6. Wolfson L, Whipple R, Judge J, et al: Balance and strength training in older adults: Intervention gains and Tai Chi maintenance. J Am Geriatr Soc 1996;44: 498Y506 7. Lui-Ambrose T, Khan KM, Eng JJ, et al: Resistance and agility training reduce fall risk in women aged 75-85 with low bone mass: A 6-month randomized, controlled trial. J Am Geriatr Soc 2004;52:657Y65 8. Li L, Manor B: Long term Tai Chi exercises improves physical performance among people with peripheral neuropathy. Am J Chin Med 2010;38:449Y59 9. Ledin T, Kronhead AC, Moller C, et al: Effects of balance training in elderly evaluated by clinical tests and dynamic posturography. J Vestib Res 1991;1:129Y38 10. Steadman J, Donaldson N, Kalra L: A randomized controlled trial of an enhanced balance training program to improve mobility and reduce falls in elderly patients. J Am Geriatr Soc 2003;51:847Y52 11. Bulat T, Hart-Hughes S, Ahmed S, et al: Effect of a group-based exercise program on balance in elderly. Clin Interv Aging 2007;2:1Y6 12. Wolf SL, Barnhart HX, Ellison GL, et al: The effect of Tai Chi Quan and computerized balance training on postural stability in older subjects. Atlanta FICSIT

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Group. Frailty and Injuries: Cooperative Studies on Intervention Techniques. Phys Ther 1997;77:371Y81 13. Fitzpatrick R, McCloskey DI: Proprioceptive, visual and vestibular thresholds for the perception of sway during standing in humans. J Physiol 1994;478:173Y86 14. Allet L, Hogene K, Ashton-Miller J, et al: Frontal plane hip and ankle sensorimotor function, not age, predicts unipedal stance time. Muscle Nerve 2012;45:578Y85 15. Son J, Ashton-Miller JA, Richardson JK: Frontal plane ankle proprioceptive thresholds and unipedal balance. Muscle Nerve 2009;39:150Y7 16. Uccioli L, Gicomini PG, Pasqualetti P, et al: Contribution of central neuropathy to postural instability in IDDM patients with peripheral neuropathy. Diabetes Care 1997;20:929Y34 17. Simoneau GG, Ulbrecht JS, Derr JA, et al: Postural instability in patients with diabetic sensory neuropathy. Diabetes Care 1994;17:1411Y21 18. Richardson JK, Ashton-Miller JA, Lee SG, et al: Moderate peripheral neuropathy impairs weight transfer and unipedal balance in the elderly. Arch Phys Med Rehabil 1996;77:1152Y6 19. Ashton-Miller JA, Yeh MWL, Richardson JK, et al: A cane reduces loss of balance in patients with peripheral neuropathy: Results from a challenging unipedal balance test. Arch Phys Med Rehabil 1996;77:446Y52 20. Gutierrez MS, Helber MB, Dealva D, et al: Mild diabetic neuropathy affects ankle motor function. Clin Biomech 2001;16:522Y8 21. Andersen H, Poulsen PL, Mogensen CE, et al: Isokinetic muscle strength in long-term IDDM patients in relation to diabetic complications. Diabetes 1996;45:440Y5 22. Richardson JK, Thies SB, DeMott T, et al: A comparison of gait characteristics between older women with and without peripheral neuropathy in standard and challenging environments. J Am Geriatr Soc 2004;52:1532Y7 23. Menz HB, Lord SR, St George R, et al: Walking stability and sensorimotor function in older people with diabetic peripheral neuropathy. Arch Phys Med Rehabil 2004;85:245Y52 24. Dingwell JB, Cusumano JP, Sternad D, et al: Slower speeds in patients with diabetic neuropathy lead to improved local dynamic stability of continuous overground walking. J Biomech 2000;33:1269Y77 25. Cavanagh PR, Derr JA, Ulbrecht JS, et al: Problems with gait and posture in neuropathic patients with insulin-dependent diabetes mellitus. Diabetes Med 1992;9:469Y74 26. Richardson JK, Ching C, Hurvitz EA: The relationship between electromyographically documented peripheral neuropathy and falls. J Am Geriatr Soc 1992;40:1008Y12 27. Richardson JK, Hurvitz EA: Peripheral neuropathy: A true risk factor for falls. J Gerontol A Biol Sci Med Sci 1995;50A:M211Y5 www.ajpmr.com

28. Allet L, Armand S, de Bie RA, et al: Gait alterations of diabetic patients while walking on different surfaces. Gait Posture 2009;29:488Y93 29. Allet L, Kim H, Ashton-Miller JA, et al: Which lower limb frontal plane sensory and motor functions predict gait speed and efficiency on uneven surfaces in older persons with diabetic neuropathy? PM R 2012;4:726Y33 30. Richardson JK, Allet L, Kim H, et al: Fibular motor conduction studies and ankle sensorimotor capacities. Muscle Nerve 2013;47:497Y503 31. Smith GB, Singleton JR: Diabetic neuropathy. Continuum (Minneap Minn) 2012;18:60Y84 32. Harris MI, Flegal KM, Cowie CC, et al: Prevalence of diabetes, impaired fasting glucose and impaired glucose tolerance in U.S. adults: The Third National Health and Nutrition Examination Survey, 1988Y1994. Diabetes Care 1998;21:518Y24 33. Franklin GM, Kahn LB, Baxter J, et al: Sensory neuropathy in non-insulin-dependent diabetes mellitus: The San Luis Valley Diabetes Study. Am J Epidemiol 1990;131:633Y43 34. Richardson JK, Sandman D, Vela S: A focused exercise regimen improves clinical measures of balance in patients with peripheral neuropathy. Arch Phys Med Rehabil 2001;82:205Y9 35. Kruse RL, Lemaster JW, Madsen RW: Fall and balance outcomes after an intervention to promote leg strength, balance and walking in people with diabetic peripheral neuropathy: BFeet first[ randomized controlled trial. Phys Ther 2010;90:1568Y79 36. Berg K, Wood-Dauphinee S, Williams JI, et al: Measuring balance scale: Reliability assessment with an elderly population. Arch Phys Med Rehabil 1989;73:1073Y80 37. Rose DJ, Jones CJ, Lucchese N: Predicting the probability of falls in community-residing older adults using the 8-foot up and go: A new measure of functional mobility. J Aging Phys Act 2002;10:466Y75 38. Hill KD, Schwarz JA, Kalogeropoulos AJ, et al: Fear of falling revisited. Arch Phys Med Rehabil 1996;77: 1025Y9 39. Davis R, Ounpuu S, Tyburski D, et al: A gait analysis data collection and reduction technique. Hum Mov Sci 10:575Y87 40. NeuroCom International, Inc: Balance Master Operators Manual. Clackamas, OR, NeuroCom Internation Inc, 1993 41. Rose R, Clark S: Can the control of bodily orientation be significantly improved in a group of older adults with a history of falls? J Am Geriatr Soc 2000;48:275Y82 42. Rose DJ, McKillop J: Assessment of Balance and Mobility Functions: A Reference Study Based on the Balance Master 6.0. Neurocom Inc, 1998 43. Wigglesworth JK, Dayhoff NE, Suhrheinrich J: The reliability of four measures of postural control using the Smart Balance Master. J Am Coll Sports Med 1997;29:S113

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44. Hintze JL: PASS 2000 User’s Guide. Kaysville, UT, Number Cruncher Statistical Systems, 2000 45. Courtemanche R, Teasdale N, Boucher P, et al: Gait problems in diabetic neuropathic patients. Arch Phys Med Rehabil 1996;77:849Y55 46. Berg WP, Alessio HM, Mills EM, et al: Circumstances and consequences of falls in independent communitydwelling older adults. Age Ageing 1997;6:261Y8 47. DeMott TK, Richardson JK, Thies SB, et al: Falls and gait characteristics among older persons with peripheral neuropathy. Am J Phys Med Rehabil 2007;86:125Y32

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50. Bean JF, Kiely DK, Herman S, et al: The relationship between leg power and physical performance in mobilitylimited older people. J Am Geriatr Soc 2002;50:461Y7 51. Allet L, Armand S, Aminian K, et al: An exercise intervention to improve diabetic patients’ gait in a reallife environment. Gait Posture 2010;32:185Y90 52. Allet L, Armand S, de Bie RA, et al: The gait and balance of patients with diabetes can be improved: A randomized controlled trial. Diabetologia 2010;52: 458Y66

48. Bauby CE, Kuo AD: Active control of lateral balance in human walking. J Biomech 2000;33:1433Y40

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his is an adult learning experience and there is no requirement for obtaining a certain score. The objective is to have each participant learn from the total experience of studying the article, taking the exam, and being able to immediately receive feedback with the correct answers. For complete information, please see BInstructions for Obtaining Continuing Medical Education Credit[ at the front of this issue. Every question must be completed on the exam answering sheet to be eligible for CME credit. Leaving any item unanswered will make void the participant’s response. This CME activity must be completed and postmarked by December 31, 2015. The documentation received will be compiled throughout the calendar year, and once a year in January, participants will receive a certificate indicating CME credits earned for the prior year of work. This CME activity was planned and produced in accordance with the ACCME Essentials.

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CME Self-Assessment Exam Questions CME Article 2014 Series Number 1: Quigley et al. 1. Individuals with distal symmetric polyneuropathy frequently demonstrate gait abnormalities such as: A. Increased step width variability B. Increased velocity and step length C. Increased step time variability D. Increased step time and time spent in dual support E. a + c + d 2. At the end of the intervention (10 week), Tai Chi group demonstrated significant improvement in which clinical outcome measure, when compared to baseline? A. 8 foot Up and Go test B. Fear of Falling (mFES) C. Berg Balance Scale (BBS) D. There was no difference in any of the measures utilized 3. At the end of the intervention (10 week), Tai Chi group demonstrated significant improvement in which gait outcome measure, when compared to baseline? A. Increased peak ankle plantar flexion power B. Increase in peak anterior and posterior ground reaction forces C. Increased single limb support time and stride length D. The improvement was found in Functional Balance training group, not Tai Chi

4. Which sensory input has been demonstrated experimentally to be of greatest importance to maintain balance during standing and walking? A. Vestibular B. Somatosensory input from the knee C. Somatosensory input from the hip and ankle D. Visual E. Somatosensory input from the ankle 5. At the end of the intervention (10 week), the Functional Balance group demonstrated significant improvement in which gait outcome measure, when compared to baseline? A. Increased peak ankle plantar flexion power B. Increase in peak anterior and posterior ground reaction forces C. Increased single limb support time and stride length D. Increase step width and step width variability

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