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The clinical impact of orthotic correction of lower limb rotational deformities in children with cerebral palsy: a randomized controlled trial Ehab Mohamed Abd El-Kafy Clin Rehabil published online 16 May 2014 DOI: 10.1177/0269215514533710 The online version of this article can be found at: http://cre.sagepub.com/content/early/2014/05/16/0269215514533710
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research-article2014
CRE0010.1177/0269215514533710Clinical RehabilitationAbd El-Kafy
CLINICAL REHABILITATION
Article
The clinical impact of orthotic correction of lower limb rotational deformities in children with cerebral palsy: a randomized controlled trial
Clinical Rehabilitation 1–11 © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0269215514533710 cre.sagepub.com
Ehab Mohamed Abd El-Kafy
Abstract Objective: This study aimed to evaluate the effectiveness of a static ground reaction ankle foot orthosis and strapping system on improving gait parameters in children with spastic diplegic cerebral palsy. Setting: The current study was conducted at the physical therapy faculty of Cairo University, Egypt. Subjects: This study included 57 children of both sexes, aged 6 to 8 years. Study design: Three-armed randomized control trial. Intervention: Participants in all groups received a traditional neuro-developmental physical therapy program that included standing and gait training exercises. Children in group A performed the training program without any orthotic management, in group B with the TheraTogs™ strapping system, and in group C with the TheraTogs™ strapping system and static ground reaction ankle foot orthoses. Children underwent treatment for two hours daily, except on weekends, for twelve successive weeks. Main measure: Gait speed, cadence, stride length, and hip and knee flexion angles in the mid-stance phase were evaluated pre-and post-treatment using a three-dimensional motion analysis system (prereflex system). Results: Statistically significant differences were recorded among the three groups post-treatment in gait speed, cadences, and stride length. The P-values for these variable differences were 0.03, 0.011, and 0.001 respectively. Significant post-treatment differences were also recorded for bilateral hip-and knee-flexion angles. For all measured parameters, better significant results were registered for group C than for the other groups. Conclusion: Orthotic intervention composed of a static ground reaction ankle foot orthosis combined with the TheraTogs™ strapping system improves gait more than conventional treatment with or without TheraTogs™ in children with spastic diplegic cerebral palsy. Keywords Cerebral palsy, femoral anteversion, tibial torsion, ankle foot orthosis, TheraTog™ Received: 6 November 2013; accepted: 7 April 2014
Department of Physical Therapy for Disturbances of Growth and Developmental Disorders in Children and its Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt Department of Physical Therapy, Faculty of Applied Medical Sciences, Umm Al Qura University, Makkah, Saudi Arabia
Corresponding author: Ehab Mohamed Abd El-Kafy, Department of Physical Therapy for Disturbances of Growth and Developmental Disorders in Children and its Surgery, Faculty of Physical Therapy, Cairo University, Giza, 12211, Egypt. Email: [email protected]
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Clinical Rehabilitation
Introduction Crouch gait is one of the most prevalent gait pathologies in children with diplegic cerebral palsy.1 It tends to be progressive and, if left untreated, it worsens with time.2 Medial femoral torsion and compensatory external tibial torsion are commonly observed in children who walk with this type of gait.3–6 Hip and knee extension are fundamental for normal gait patterns.7 The capacity of muscles to extend the joints depends on the geometry of bones and joints, so that mal-directed or rotated levers could reduce the effectiveness of muscle action.8 Excessive femoral anteversion and external tibial torsion deformities had the greatest impact on soleus and posterior gluteus medius. Correction of these deformities may be particularly important in patients with weak plantar flexors or gluteal muscles.9–12 There are many physical therapy techniques used to correct lower limb deformities in the sagittal plane, but there is no clear technique to correct rotational deformities in the transverse plane. Controlling crouched gait with increased hip and knee flexion and ankle dorsiflexion in stance phase is best done using solid ground reaction ankle foot orthoses. It is useful only for ambulatory children.13,14 Using spiral strapping to rotate the femur externally and the tibia medially may correct lower limb joint angles in the transverse and sagittal planes during walking.15TheraTogs™ orthotic undergarments have been developed to provide a gentle, passive force to correct alignment through the combination of a trunk-and-shorts system with a customized external strapping system. It is suggested that this system can improve joint stability, posture, and gait skills.16 Some studies in the literature have evaluated the effectiveness of ground reaction ankle foot orthoses in improving gait parameters and knee extension moment in children with cerebral palsy. Others have used external strapping to overcome torsional deformities of the lower extremities to improve gait functions in children.17 But to our knowledge no studies utilized the combination of ground reaction ankle foot orthoses with spiral strapping for
improving hip and knee extension in a single support phase of gait limb stance. The purpose of this study was to examine the effect of orthotic intervention, consisting of a ground reaction ankle foot orthosis and TheraTogs™ orthotic undergarment with spiral strapping on knee and hip rotational angles and flexion angles in the sagittal plane during mid stance phase of gait cycle in ambulant children with spastic diplegic cerebral palsy. It also aimed to evaluate the impact of this correction on gait speed, cadence, and stride length.
Methodology This study was approved by the Ethics Review Committee from the Faculty of Physical Therapy, Cairo University and parents signed a consent form authorizing the child’s participation. The participating children were recruited from out-patient clinic of the Faculty of Physical Therapy and Al Kaser Al Eini Hospital, Cairo University. Many children with spastic diplegic cerebral palsy were initially screened and assessed to determine age, diagnosis, and inclusion and exclusion criteria. The inclusion criteria were as follows: the participating children had a confirmed diagnosis of spastic diplegic cerebral palsy in the prenatal, perinatal, or postnatal period. They were all between 6 and 8 years old, of both sexes. They each weighed less than 40kg. The demographic characteristics of the participating children are illustrated in Table 1. Children were cognitively able to understand and follow instructions. There were no serious or recurring medical complications according to the medical report signed by their physicians. They did not receive any physical therapy interventions prestudy except the traditional neuro-developmental program. No significant hip and knee flexion contracture was present (i.e., < 10 degrees).17 They had no major rotational mal-alignment in lower limbs. Their external tibial torsion was between 20 and 30 degrees, and femoral anteversion was within 15 to 30 degrees, as assessed by the researcher and pediatric orthopedist using the rotational profile, the method described by Staheli et al.18 and Staheli and
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3
Abd El-Kafy Table 1. Demographic characteristics of participants. Variables
GA (n = 19)
GB (n = 19)
GC (n = 19)
Age (mean years + SD) Sex (boys/girls) Weight (mean Kg + SD) MAS grades 1 1+ 2 GMFCS level I II
7.5 ± 1.2 12 boys 7 girls 29.4± 1.9
7.3 ± 1.6 10 boys 9 girls 28.1± 2.6
7.1 ± 1.5 9 boys 10 girls 27.6± 2.8 6 9 4 8 11
7 9 3
5 10 4
10 9
7 12
MAS: Modified Ashworth Scale, GMFCS: Gross Motor Function Classification System, GA: group A, GB: group B GC: group C.
Engel.19 Knee flexion at initial contact was between 20 and 40 degrees. The exclusion criteria were as follows: (1) any orthopedic conditions identified by the physician’s referral that were contraindicative of positioning the child in hip external rotation and tibial internal rotation, (2) children who demonstrated allergic reactions to the adhesive tape or any other materials used in this study, (3) children with visual, auditory, or perceptual deficits or seizures, (4) children who previously received any TheraTogs™ orthotic undergarment, or strapping system and ground reaction ankle foot orthosis pre-treatment and (5) children who had received botulinum toxin in the lower extremity musculature during the past six months or other spasticity medication within three months of pre-treatment testing. The research design of this study was threearmed randomized control trial. To avoid a type II error, a preliminary power analysis (power = 0.8, α = 0.05, effect size = 0.5, groups = 3 and evaluation times = 2) determined a sample size of 51 for this study. The recruitment process and the flow of participants throughout the study are illustrated in Figure 1. A randomized trial was used as the participants did not know to which group they were assigned and which treatment would be taken. Randomization was performed by a statistician who was blinded to the study treatment and procedures’ details. It was performed simply by adding a
specific identification number for each child. A SPSS program (version 16) was used to randomly assign children to groups. The recruited children were allocated in three equal groups of 19 children each: control group A and study groups B and C. Sequentially numbered, opaque, sealed assignment envelopes were used to conceal the allocation. Each envelope contained a paper with the name of the group for allocation. An external independent person with no other involvement with the study performed the envelope opening process in front of the participants; each envelope was marked after being opened so as not to be used again. All envelopes were kept secured until the end of the study.
Intervention The control group A received the traditional neurodevelopmental physical therapy program that includes standing and gait training exercises without any orthotic intervention. The study group B received the same program as group A, plus TheraTogs™ orthotic undergarment and strapping system for both lower extremities. The study group C received treatment regimen similar to that of group B, and in addition received solid ground reaction ankle foot orthoses in both lower limbs. The standing and gait training exercises regimen for all groups is fully illustrated in Appendix 1
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Clinical Rehabilitation
Total number of children selected for this Study (n=97)
Exclusion n = 40 Not meeting inclusion criteria (n= 35); refused to participate (n= 5)
Total number of participants registered n =57 (31 boys/26 girls)
Randomized
Group A n = 19
Group B n = 19
Received allocated intervention n = 18
Group C n = 19
Received allocated intervention n = 16
Losses (n = 1): Reasons for discontinued intervention: irregularity in receiving the treatment program (1)
Losses (n = 3): Reasons for discontinued intervention: transportation difficulties (2) refused to complete study (1)
Outcome data 12 weeks: n = 18 with data
Outcome data 12 weeks: n = 16 with data
Received allocated intervention n = 17 Losses (n = 2): Reasons for discontinued intervention: fall accident and hospitalization (1); transportation difficulties (1).
Outcome data 12 weeks: n = 17 with data
Figure 1. Flow diagram of the study.
(supplementary material). It was applied two hours daily for 12 successive weeks, except on weekends, when there was no training. The conventional program was applied by three well-trained physical therapists, each of them responsible for conducting certain exercises or a part of the program for all children in different groups. The researcher was responsible for fitting the TheraTogs™ orthotic undergarment and strapping system and also the solid ground reaction ankle foot orthosis for all participating children in groups B and C. The strapping technique was applied using TheraTogs™ orthotic undergarment and strapping system developed by Cusick (1997).20 A TheraTogs™ garment consists of a sleeveless
tank-top and two shorts (hipster), each with two thigh and limb cuffs. The strapping technique used to reduce excessive femoral anteversion and facilitate hip lateral rotation included the following steps: (1) the child began in standing position; (2) a wide straight strap was attached to the lower back of each thigh cuff; (3) the hip was manually rotated laterally without force; and (4) the strap was pulled up in a spiral pattern over the inner thigh, the front thigh, the hip joint, into the lower tank-top back panel in the sacral region, and stacked midway between the posterior and superior iliac spines. The strap was passed just above the hip joint to facilitate hip abduction and extension.
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Abd El-Kafy The strapping technique used to reduce excessive external tibial torsion and facilitate medial leg rotation included: (1) the child began in standing position; (2) limb cuff was applied above the ankle; (3) one end of a straight strap was attached to the back of the limb cuff directed upward and outward; (3) the leg was manually rotated inward without force; and (4) the strap was pulled up and out in a spiral pattern around the upper anterior leg, around the inner knee, into the back of hipster, and stacked behind the thigh. The following precautions were considered when applying this strapping technique: the wearer should be comfortable without feeling constriction, itching, or circulatory impairment and the garments should be snug against the skin, with no significant gaps, folds, or loose material. The intervention phase used in this study was adapted and modified from Flanagan et al.16 It consisted of wearing an individualized TheraTogs™ and strapping system for 12 successive weeks, 12 successive hours per day including the period of standing and gait training, except on weekends, when the children had no strapping. Therapeutic strapping was applied in the morning by the therapist and removed in the evening by the parent. The TheraTogs™ strapping system used in this study was an undergarment that participating children wore under their usual clothes, so it was not annoying or disturbing. A ground reaction ankle foot orthosis is a custom fabricated, molded plastic device that supports the ankle and foot area of the body. The orthosis used in this study was a solid one, composed of one piece that enclosed the back of the lower calf, the shin, and the bottom of the foot. It extended below the knee, around the tibia anteriorly, and down to the ankle posteriorly, including the foot. Because the tibial angle to the floor is critical in determining knee stability, the ankle was held at 90 degrees to the floor to provide more stability. The length of the footplate was extended to the end of the toes to increase the knee extension moment arm. After application of the ground reaction ankle foot orthosis, it was made sure that: (1) the heel was fully seated inside the orthosis, (2) the heel was in contact with the bottom of the footplate, (3)
the heel was all the way back (confirmed by looking along the sides and back of the footplate), (4) the Velcro of the wrap-around strap was fully secured just above the ankle, (5) the foot with orthosis slid well into the shoe, special shoes were not needed to wear over the orthosis, but a larger shoe size might be indicated. If it was necessary, the insole of the shoe was removed to accommodate the orthosis, and (6) shoelaces/Velcro were tightened securely. Each child wore the orthosis for two hours, during the standing and gait training exercise regimen.
Assessment Assessments, pre- and post-treatment, were conducted by 'blind' examiners who did not engage in the intervention program and did not know which group each child was in. Evaluation was carried out to measure the knee and hip rotational and flexion joints angles in mid-stance phase and selected gait parameters (speed, cadence, and stride length) using the pro-reflex system, a 3-dimensional system consisting of an eight-meter-long wooden walkway, six infrared cameras, a wand-kit for calibration of the system, an ACB-530 serial interface adapter, and a personal computer with Q-Trac software installed to analyze the gait parameters. Reflective markers, each of nine millimeters in diameters were enclosed in the pro-reflex system. They were suitable for optimizing the focus setting of the camera. For each child, the markers were placed and fixed bilaterally using a sticky material on the following bony landmarks (sacrum, anterior superior iliac spine, superior border of the patella, laterally at the knee joint line, tibial tuberosity, lateral malleolus, heel posterior of the calcaneus, and between the 2nd and 3rd metatarsal heads). The evaluation procedures were applied for all participating children in all groups both pre- and immediately post-treatment. The assessment was performed without any orthotic intervention, 30 minutes after removing the TheraTogs™ orthotic undergarment, strapping system and the ground reaction ankle foot orthosis. Before starting the gait analysis procedure, the ACB-530 board was properly set up, as well as the
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Clinical Rehabilitation
Table 2. Comparison of the mean values of the measured gait parameters (stride length, cadence and speed) within each group from pre to post-treatment and among the three groups in pre and post treatment evaluation times. Variable Stride length (cm)
Cadence (steps/min)
Speed (m/min)
Group
Pre-Mean ± SD Post-Mean ± SD Pre-Mean ± SD Post-Mean ± SD Pre-Mean ± SD Post-Mean ± SD
Group (A) Group (B) Group (C) F-value P-value
69±3.16 68±4-84 71±3.16 1.933 0.161a
77±3.69 83±4.39 89±4.04 26.54 0.001b
64.5±3.29 63.42±4.42 62.5±4.36 0.73 0.48a
68.59±4.42 69.25±3.54 73.42±3.89 5.21 0.011b
44.25±3.55 45.51±3.69 44.5±3.23 0.44 0.65a
47.7±3.52 48.56±3.12 51.5±3.8 3.89 0.03b
a: non-significant difference among the three groups in each evaluation time (ANOVA test; P < 0.05), b: significant difference among the three groups in each evaluation time (ANOVA test; P < 0.05).
camera system. Then the camera system was calibrated with a reference structure and a wand, to provide the cameras with the measurement points used for calibration. Each child was prepared for evaluation by attaching reflective dots (markers) bilaterally on the bony landmarks. Then, the child was asked to walk along the walkway (8m), while being videotaped. Two trials were done before recording to familiarize the child with the system. The entire gait cycle was captured within the volume from initial contact of one foot to the second toe-off of the other foot. The marker displacements were analyzed with the Q-gait interface. Special considerations were taken during the capturing process, such as: the child should not be distracted by anything in the room; each child was asked to start walking from a position far enough away from the measurement volume to reach a natural walking pattern before measurement, and the child was allowed to continue walking several meters after the measurement volume.
Statistical analysis Results were expressed as mean ± standard deviation (SD). For all measured parameters, the comparison among the three groups A, B, and C, pre- and immediately post-treatment, was carried out by conducting ANOVA with repeated measurement test and Least Significant Difference test. While comparing between groups B and C, preand immediate post-treatment mean values were determined using un-paired t tests.
SPSS computer program version 16.00 was used for data analysis. P values less than 0.05 were considered significant.
Results From the 97 children selected for this study, 57 met the inclusion criteria and participated in this study; see Fgure 1 and Table 1. By chance, all selected children were right-handed. The results of this study, as illustrated in Tables 2 and 3, showed that there were no statistically significant differences among the three groups pretreatment in all measured variables (gait speed, cadence, stride length, and bilateral hip and knee flexion angles), and that they were present posttreatment. The statistically significant differences post-treatment, in all parameters, were greater in group C than that in both groups A and B, as shown in Table 4. The results concerning the mean values of bilateral hip and knee rotational angles between both groups B and C revealed that there were no statistically significant differences in either pre- or post-treatment evaluation times, as illustrated in Table 5. It should also be noted that in all cases the within-group change over time was statistically significant.
Discussion The results of this study suggest that using spiral strapping in combination with solid ground reaction ankle foot orthosis to overcome femoral
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Abd El-Kafy
Table 3. Comparison of the mean values of bilateral hips and knee flexion angles (degrees) within each group from pre to post-treatment and among the three groups in pre and post-treatment evaluation times. Variable
Rt Hip flexion angle (degree)
Lt Hip flexion angle (degree)
Group
Pre-Mean ± SD
Post-Mean ± SD
Pre-Mean ± SD
Post-Mean ± SD
Group (A) Group (B) Group (C) F-value P-value
29.36±3.71° 28.47±4.31° 27.35±4.43° F=0.71 P=0.49a
26.45±3.36° 21.18±3.43° 17.47±2.85° F=23.48 P=0.001b
24.45 ±3.07° 24.75±4.68° 23.72±3.21° F=0.24 P=0.78a
22.18±2.41° 20.34±2.36° 18.44±2.59° F=6.94 P=0.003b
Rt knee flexion angle (degree)
Lt knee flexion angle (degree)
Group (A) Group (B) Group (C) F-value P-value
35.39± 3.96° 36.85±3.18° 36.27±3.15° F=0.54 P=0.58a
32.13±3.82° 34.76±3.13° 33.08±3.14° F=1.86 P=0.17a
31.54± 4.16° 30.91± 2.59° 24.42±3.86° F=14.33 P=0.001b
29.75±2.35° 30.39±3.17° 25.84±3.14° F=8.57 P=0.001b
°:angle degree, Rt: right, Lt: left. a: non-significant difference among the three groups in each evaluation time (ANOVA test; P < 0.05). b: significant difference among the three groups in each evaluation time (ANOVA test; P < 0.05).
Table 4. Comparison of post-treatment mean values of all measured variables between every both of groups A, B and C. Variable
Group Stat variable
A&B
A&C
B&C
Rt hip flexion angle Lt hip flexion angle Rt knee flexion angle Lt knee flexion angle Stride length (cm) Cadence (steps/min) Speed (m/min)
Mean Difference Significance Mean Difference Significance Mean Difference Significance Mean Difference Significance Mean Difference Significance Mean Difference Significance Mean Difference Significance
5.26 P = 0.001a 1.83 P = 0.076b 0.63 P = 0.67b –0.63 P = 0.59b –5 P = 0.005a –0.65 P = 0.68b –0.86 P = 0.54b
8.98 P =0.001a 3.74 P = 0.001a 7.12 P = 0.001a 3.91 P =0.002a –12 P = 0.001a –4.83 P = 0.005a –3.8 P = 0.012a
3.71 P =0.008a 1.89 P = 0.047a 6.48 P = 0.001a 4.55 P = 0.001a –7 P = 0.001a –4.17 P = 0.015a –2.93 P = 0.048 a
Stat: statistical, Rt: right, Lt: left. a: significant difference between every two groups post treatment (Least Significant Difference; P
The clinical impact of orthotic correction of lower limb rotational deformities in children with cerebral palsy: a randomized controlled trial Ehab Mohamed Abd El-Kafy Clin Rehabil published online 16 May 2014 DOI: 10.1177/0269215514533710 The online version of this article can be found at: http://cre.sagepub.com/content/early/2014/05/16/0269215514533710
Published by: http://www.sagepublications.com
Additional services and information for Clinical Rehabilitation can be found at: Email Alerts: http://cre.sagepub.com/cgi/alerts Subscriptions: http://cre.sagepub.com/subscriptions Reprints: http://www.sagepub.com/journalsReprints.nav Permissions: http://www.sagepub.com/journalsPermissions.nav
>> OnlineFirst Version of Record - May 16, 2014 What is This?
Downloaded from cre.sagepub.com at CLARKSON UNIV LIBRARY on August 20, 2014
533710
research-article2014
CRE0010.1177/0269215514533710Clinical RehabilitationAbd El-Kafy
CLINICAL REHABILITATION
Article
The clinical impact of orthotic correction of lower limb rotational deformities in children with cerebral palsy: a randomized controlled trial
Clinical Rehabilitation 1–11 © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav DOI: 10.1177/0269215514533710 cre.sagepub.com
Ehab Mohamed Abd El-Kafy
Abstract Objective: This study aimed to evaluate the effectiveness of a static ground reaction ankle foot orthosis and strapping system on improving gait parameters in children with spastic diplegic cerebral palsy. Setting: The current study was conducted at the physical therapy faculty of Cairo University, Egypt. Subjects: This study included 57 children of both sexes, aged 6 to 8 years. Study design: Three-armed randomized control trial. Intervention: Participants in all groups received a traditional neuro-developmental physical therapy program that included standing and gait training exercises. Children in group A performed the training program without any orthotic management, in group B with the TheraTogs™ strapping system, and in group C with the TheraTogs™ strapping system and static ground reaction ankle foot orthoses. Children underwent treatment for two hours daily, except on weekends, for twelve successive weeks. Main measure: Gait speed, cadence, stride length, and hip and knee flexion angles in the mid-stance phase were evaluated pre-and post-treatment using a three-dimensional motion analysis system (prereflex system). Results: Statistically significant differences were recorded among the three groups post-treatment in gait speed, cadences, and stride length. The P-values for these variable differences were 0.03, 0.011, and 0.001 respectively. Significant post-treatment differences were also recorded for bilateral hip-and knee-flexion angles. For all measured parameters, better significant results were registered for group C than for the other groups. Conclusion: Orthotic intervention composed of a static ground reaction ankle foot orthosis combined with the TheraTogs™ strapping system improves gait more than conventional treatment with or without TheraTogs™ in children with spastic diplegic cerebral palsy. Keywords Cerebral palsy, femoral anteversion, tibial torsion, ankle foot orthosis, TheraTog™ Received: 6 November 2013; accepted: 7 April 2014
Department of Physical Therapy for Disturbances of Growth and Developmental Disorders in Children and its Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt Department of Physical Therapy, Faculty of Applied Medical Sciences, Umm Al Qura University, Makkah, Saudi Arabia
Corresponding author: Ehab Mohamed Abd El-Kafy, Department of Physical Therapy for Disturbances of Growth and Developmental Disorders in Children and its Surgery, Faculty of Physical Therapy, Cairo University, Giza, 12211, Egypt. Email: [email protected]
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2
Clinical Rehabilitation
Introduction Crouch gait is one of the most prevalent gait pathologies in children with diplegic cerebral palsy.1 It tends to be progressive and, if left untreated, it worsens with time.2 Medial femoral torsion and compensatory external tibial torsion are commonly observed in children who walk with this type of gait.3–6 Hip and knee extension are fundamental for normal gait patterns.7 The capacity of muscles to extend the joints depends on the geometry of bones and joints, so that mal-directed or rotated levers could reduce the effectiveness of muscle action.8 Excessive femoral anteversion and external tibial torsion deformities had the greatest impact on soleus and posterior gluteus medius. Correction of these deformities may be particularly important in patients with weak plantar flexors or gluteal muscles.9–12 There are many physical therapy techniques used to correct lower limb deformities in the sagittal plane, but there is no clear technique to correct rotational deformities in the transverse plane. Controlling crouched gait with increased hip and knee flexion and ankle dorsiflexion in stance phase is best done using solid ground reaction ankle foot orthoses. It is useful only for ambulatory children.13,14 Using spiral strapping to rotate the femur externally and the tibia medially may correct lower limb joint angles in the transverse and sagittal planes during walking.15TheraTogs™ orthotic undergarments have been developed to provide a gentle, passive force to correct alignment through the combination of a trunk-and-shorts system with a customized external strapping system. It is suggested that this system can improve joint stability, posture, and gait skills.16 Some studies in the literature have evaluated the effectiveness of ground reaction ankle foot orthoses in improving gait parameters and knee extension moment in children with cerebral palsy. Others have used external strapping to overcome torsional deformities of the lower extremities to improve gait functions in children.17 But to our knowledge no studies utilized the combination of ground reaction ankle foot orthoses with spiral strapping for
improving hip and knee extension in a single support phase of gait limb stance. The purpose of this study was to examine the effect of orthotic intervention, consisting of a ground reaction ankle foot orthosis and TheraTogs™ orthotic undergarment with spiral strapping on knee and hip rotational angles and flexion angles in the sagittal plane during mid stance phase of gait cycle in ambulant children with spastic diplegic cerebral palsy. It also aimed to evaluate the impact of this correction on gait speed, cadence, and stride length.
Methodology This study was approved by the Ethics Review Committee from the Faculty of Physical Therapy, Cairo University and parents signed a consent form authorizing the child’s participation. The participating children were recruited from out-patient clinic of the Faculty of Physical Therapy and Al Kaser Al Eini Hospital, Cairo University. Many children with spastic diplegic cerebral palsy were initially screened and assessed to determine age, diagnosis, and inclusion and exclusion criteria. The inclusion criteria were as follows: the participating children had a confirmed diagnosis of spastic diplegic cerebral palsy in the prenatal, perinatal, or postnatal period. They were all between 6 and 8 years old, of both sexes. They each weighed less than 40kg. The demographic characteristics of the participating children are illustrated in Table 1. Children were cognitively able to understand and follow instructions. There were no serious or recurring medical complications according to the medical report signed by their physicians. They did not receive any physical therapy interventions prestudy except the traditional neuro-developmental program. No significant hip and knee flexion contracture was present (i.e., < 10 degrees).17 They had no major rotational mal-alignment in lower limbs. Their external tibial torsion was between 20 and 30 degrees, and femoral anteversion was within 15 to 30 degrees, as assessed by the researcher and pediatric orthopedist using the rotational profile, the method described by Staheli et al.18 and Staheli and
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3
Abd El-Kafy Table 1. Demographic characteristics of participants. Variables
GA (n = 19)
GB (n = 19)
GC (n = 19)
Age (mean years + SD) Sex (boys/girls) Weight (mean Kg + SD) MAS grades 1 1+ 2 GMFCS level I II
7.5 ± 1.2 12 boys 7 girls 29.4± 1.9
7.3 ± 1.6 10 boys 9 girls 28.1± 2.6
7.1 ± 1.5 9 boys 10 girls 27.6± 2.8 6 9 4 8 11
7 9 3
5 10 4
10 9
7 12
MAS: Modified Ashworth Scale, GMFCS: Gross Motor Function Classification System, GA: group A, GB: group B GC: group C.
Engel.19 Knee flexion at initial contact was between 20 and 40 degrees. The exclusion criteria were as follows: (1) any orthopedic conditions identified by the physician’s referral that were contraindicative of positioning the child in hip external rotation and tibial internal rotation, (2) children who demonstrated allergic reactions to the adhesive tape or any other materials used in this study, (3) children with visual, auditory, or perceptual deficits or seizures, (4) children who previously received any TheraTogs™ orthotic undergarment, or strapping system and ground reaction ankle foot orthosis pre-treatment and (5) children who had received botulinum toxin in the lower extremity musculature during the past six months or other spasticity medication within three months of pre-treatment testing. The research design of this study was threearmed randomized control trial. To avoid a type II error, a preliminary power analysis (power = 0.8, α = 0.05, effect size = 0.5, groups = 3 and evaluation times = 2) determined a sample size of 51 for this study. The recruitment process and the flow of participants throughout the study are illustrated in Figure 1. A randomized trial was used as the participants did not know to which group they were assigned and which treatment would be taken. Randomization was performed by a statistician who was blinded to the study treatment and procedures’ details. It was performed simply by adding a
specific identification number for each child. A SPSS program (version 16) was used to randomly assign children to groups. The recruited children were allocated in three equal groups of 19 children each: control group A and study groups B and C. Sequentially numbered, opaque, sealed assignment envelopes were used to conceal the allocation. Each envelope contained a paper with the name of the group for allocation. An external independent person with no other involvement with the study performed the envelope opening process in front of the participants; each envelope was marked after being opened so as not to be used again. All envelopes were kept secured until the end of the study.
Intervention The control group A received the traditional neurodevelopmental physical therapy program that includes standing and gait training exercises without any orthotic intervention. The study group B received the same program as group A, plus TheraTogs™ orthotic undergarment and strapping system for both lower extremities. The study group C received treatment regimen similar to that of group B, and in addition received solid ground reaction ankle foot orthoses in both lower limbs. The standing and gait training exercises regimen for all groups is fully illustrated in Appendix 1
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Clinical Rehabilitation
Total number of children selected for this Study (n=97)
Exclusion n = 40 Not meeting inclusion criteria (n= 35); refused to participate (n= 5)
Total number of participants registered n =57 (31 boys/26 girls)
Randomized
Group A n = 19
Group B n = 19
Received allocated intervention n = 18
Group C n = 19
Received allocated intervention n = 16
Losses (n = 1): Reasons for discontinued intervention: irregularity in receiving the treatment program (1)
Losses (n = 3): Reasons for discontinued intervention: transportation difficulties (2) refused to complete study (1)
Outcome data 12 weeks: n = 18 with data
Outcome data 12 weeks: n = 16 with data
Received allocated intervention n = 17 Losses (n = 2): Reasons for discontinued intervention: fall accident and hospitalization (1); transportation difficulties (1).
Outcome data 12 weeks: n = 17 with data
Figure 1. Flow diagram of the study.
(supplementary material). It was applied two hours daily for 12 successive weeks, except on weekends, when there was no training. The conventional program was applied by three well-trained physical therapists, each of them responsible for conducting certain exercises or a part of the program for all children in different groups. The researcher was responsible for fitting the TheraTogs™ orthotic undergarment and strapping system and also the solid ground reaction ankle foot orthosis for all participating children in groups B and C. The strapping technique was applied using TheraTogs™ orthotic undergarment and strapping system developed by Cusick (1997).20 A TheraTogs™ garment consists of a sleeveless
tank-top and two shorts (hipster), each with two thigh and limb cuffs. The strapping technique used to reduce excessive femoral anteversion and facilitate hip lateral rotation included the following steps: (1) the child began in standing position; (2) a wide straight strap was attached to the lower back of each thigh cuff; (3) the hip was manually rotated laterally without force; and (4) the strap was pulled up in a spiral pattern over the inner thigh, the front thigh, the hip joint, into the lower tank-top back panel in the sacral region, and stacked midway between the posterior and superior iliac spines. The strap was passed just above the hip joint to facilitate hip abduction and extension.
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Abd El-Kafy The strapping technique used to reduce excessive external tibial torsion and facilitate medial leg rotation included: (1) the child began in standing position; (2) limb cuff was applied above the ankle; (3) one end of a straight strap was attached to the back of the limb cuff directed upward and outward; (3) the leg was manually rotated inward without force; and (4) the strap was pulled up and out in a spiral pattern around the upper anterior leg, around the inner knee, into the back of hipster, and stacked behind the thigh. The following precautions were considered when applying this strapping technique: the wearer should be comfortable without feeling constriction, itching, or circulatory impairment and the garments should be snug against the skin, with no significant gaps, folds, or loose material. The intervention phase used in this study was adapted and modified from Flanagan et al.16 It consisted of wearing an individualized TheraTogs™ and strapping system for 12 successive weeks, 12 successive hours per day including the period of standing and gait training, except on weekends, when the children had no strapping. Therapeutic strapping was applied in the morning by the therapist and removed in the evening by the parent. The TheraTogs™ strapping system used in this study was an undergarment that participating children wore under their usual clothes, so it was not annoying or disturbing. A ground reaction ankle foot orthosis is a custom fabricated, molded plastic device that supports the ankle and foot area of the body. The orthosis used in this study was a solid one, composed of one piece that enclosed the back of the lower calf, the shin, and the bottom of the foot. It extended below the knee, around the tibia anteriorly, and down to the ankle posteriorly, including the foot. Because the tibial angle to the floor is critical in determining knee stability, the ankle was held at 90 degrees to the floor to provide more stability. The length of the footplate was extended to the end of the toes to increase the knee extension moment arm. After application of the ground reaction ankle foot orthosis, it was made sure that: (1) the heel was fully seated inside the orthosis, (2) the heel was in contact with the bottom of the footplate, (3)
the heel was all the way back (confirmed by looking along the sides and back of the footplate), (4) the Velcro of the wrap-around strap was fully secured just above the ankle, (5) the foot with orthosis slid well into the shoe, special shoes were not needed to wear over the orthosis, but a larger shoe size might be indicated. If it was necessary, the insole of the shoe was removed to accommodate the orthosis, and (6) shoelaces/Velcro were tightened securely. Each child wore the orthosis for two hours, during the standing and gait training exercise regimen.
Assessment Assessments, pre- and post-treatment, were conducted by 'blind' examiners who did not engage in the intervention program and did not know which group each child was in. Evaluation was carried out to measure the knee and hip rotational and flexion joints angles in mid-stance phase and selected gait parameters (speed, cadence, and stride length) using the pro-reflex system, a 3-dimensional system consisting of an eight-meter-long wooden walkway, six infrared cameras, a wand-kit for calibration of the system, an ACB-530 serial interface adapter, and a personal computer with Q-Trac software installed to analyze the gait parameters. Reflective markers, each of nine millimeters in diameters were enclosed in the pro-reflex system. They were suitable for optimizing the focus setting of the camera. For each child, the markers were placed and fixed bilaterally using a sticky material on the following bony landmarks (sacrum, anterior superior iliac spine, superior border of the patella, laterally at the knee joint line, tibial tuberosity, lateral malleolus, heel posterior of the calcaneus, and between the 2nd and 3rd metatarsal heads). The evaluation procedures were applied for all participating children in all groups both pre- and immediately post-treatment. The assessment was performed without any orthotic intervention, 30 minutes after removing the TheraTogs™ orthotic undergarment, strapping system and the ground reaction ankle foot orthosis. Before starting the gait analysis procedure, the ACB-530 board was properly set up, as well as the
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Clinical Rehabilitation
Table 2. Comparison of the mean values of the measured gait parameters (stride length, cadence and speed) within each group from pre to post-treatment and among the three groups in pre and post treatment evaluation times. Variable Stride length (cm)
Cadence (steps/min)
Speed (m/min)
Group
Pre-Mean ± SD Post-Mean ± SD Pre-Mean ± SD Post-Mean ± SD Pre-Mean ± SD Post-Mean ± SD
Group (A) Group (B) Group (C) F-value P-value
69±3.16 68±4-84 71±3.16 1.933 0.161a
77±3.69 83±4.39 89±4.04 26.54 0.001b
64.5±3.29 63.42±4.42 62.5±4.36 0.73 0.48a
68.59±4.42 69.25±3.54 73.42±3.89 5.21 0.011b
44.25±3.55 45.51±3.69 44.5±3.23 0.44 0.65a
47.7±3.52 48.56±3.12 51.5±3.8 3.89 0.03b
a: non-significant difference among the three groups in each evaluation time (ANOVA test; P < 0.05), b: significant difference among the three groups in each evaluation time (ANOVA test; P < 0.05).
camera system. Then the camera system was calibrated with a reference structure and a wand, to provide the cameras with the measurement points used for calibration. Each child was prepared for evaluation by attaching reflective dots (markers) bilaterally on the bony landmarks. Then, the child was asked to walk along the walkway (8m), while being videotaped. Two trials were done before recording to familiarize the child with the system. The entire gait cycle was captured within the volume from initial contact of one foot to the second toe-off of the other foot. The marker displacements were analyzed with the Q-gait interface. Special considerations were taken during the capturing process, such as: the child should not be distracted by anything in the room; each child was asked to start walking from a position far enough away from the measurement volume to reach a natural walking pattern before measurement, and the child was allowed to continue walking several meters after the measurement volume.
Statistical analysis Results were expressed as mean ± standard deviation (SD). For all measured parameters, the comparison among the three groups A, B, and C, pre- and immediately post-treatment, was carried out by conducting ANOVA with repeated measurement test and Least Significant Difference test. While comparing between groups B and C, preand immediate post-treatment mean values were determined using un-paired t tests.
SPSS computer program version 16.00 was used for data analysis. P values less than 0.05 were considered significant.
Results From the 97 children selected for this study, 57 met the inclusion criteria and participated in this study; see Fgure 1 and Table 1. By chance, all selected children were right-handed. The results of this study, as illustrated in Tables 2 and 3, showed that there were no statistically significant differences among the three groups pretreatment in all measured variables (gait speed, cadence, stride length, and bilateral hip and knee flexion angles), and that they were present posttreatment. The statistically significant differences post-treatment, in all parameters, were greater in group C than that in both groups A and B, as shown in Table 4. The results concerning the mean values of bilateral hip and knee rotational angles between both groups B and C revealed that there were no statistically significant differences in either pre- or post-treatment evaluation times, as illustrated in Table 5. It should also be noted that in all cases the within-group change over time was statistically significant.
Discussion The results of this study suggest that using spiral strapping in combination with solid ground reaction ankle foot orthosis to overcome femoral
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Abd El-Kafy
Table 3. Comparison of the mean values of bilateral hips and knee flexion angles (degrees) within each group from pre to post-treatment and among the three groups in pre and post-treatment evaluation times. Variable
Rt Hip flexion angle (degree)
Lt Hip flexion angle (degree)
Group
Pre-Mean ± SD
Post-Mean ± SD
Pre-Mean ± SD
Post-Mean ± SD
Group (A) Group (B) Group (C) F-value P-value
29.36±3.71° 28.47±4.31° 27.35±4.43° F=0.71 P=0.49a
26.45±3.36° 21.18±3.43° 17.47±2.85° F=23.48 P=0.001b
24.45 ±3.07° 24.75±4.68° 23.72±3.21° F=0.24 P=0.78a
22.18±2.41° 20.34±2.36° 18.44±2.59° F=6.94 P=0.003b
Rt knee flexion angle (degree)
Lt knee flexion angle (degree)
Group (A) Group (B) Group (C) F-value P-value
35.39± 3.96° 36.85±3.18° 36.27±3.15° F=0.54 P=0.58a
32.13±3.82° 34.76±3.13° 33.08±3.14° F=1.86 P=0.17a
31.54± 4.16° 30.91± 2.59° 24.42±3.86° F=14.33 P=0.001b
29.75±2.35° 30.39±3.17° 25.84±3.14° F=8.57 P=0.001b
°:angle degree, Rt: right, Lt: left. a: non-significant difference among the three groups in each evaluation time (ANOVA test; P < 0.05). b: significant difference among the three groups in each evaluation time (ANOVA test; P < 0.05).
Table 4. Comparison of post-treatment mean values of all measured variables between every both of groups A, B and C. Variable
Group Stat variable
A&B
A&C
B&C
Rt hip flexion angle Lt hip flexion angle Rt knee flexion angle Lt knee flexion angle Stride length (cm) Cadence (steps/min) Speed (m/min)
Mean Difference Significance Mean Difference Significance Mean Difference Significance Mean Difference Significance Mean Difference Significance Mean Difference Significance Mean Difference Significance
5.26 P = 0.001a 1.83 P = 0.076b 0.63 P = 0.67b –0.63 P = 0.59b –5 P = 0.005a –0.65 P = 0.68b –0.86 P = 0.54b
8.98 P =0.001a 3.74 P = 0.001a 7.12 P = 0.001a 3.91 P =0.002a –12 P = 0.001a –4.83 P = 0.005a –3.8 P = 0.012a
3.71 P =0.008a 1.89 P = 0.047a 6.48 P = 0.001a 4.55 P = 0.001a –7 P = 0.001a –4.17 P = 0.015a –2.93 P = 0.048 a
Stat: statistical, Rt: right, Lt: left. a: significant difference between every two groups post treatment (Least Significant Difference; P
