Dynamic Orthotic Garment in Diplegic Cerebral Palsy

Study Overview
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Brief Summary
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This study aims to evaluate the effectiveness of dynamic orthotic garment (Thera togs) on foot pressure distribution, postural control, functional performance and endurance in children with spastic diplegic cerebral palsy (CP). Methods: forty children with spastic diplegic CP, with ages ranging from 8 to 10 years, will be assigned randomly into two groups. The control group will receive the conventional physical therapy, whereas the study group will receive the same program as the control group in addition to Thera togs. Measurement of foot pressure distribution will be performed using a pressure platform, postural control will be evaluated using the trunk control measurement scale Trunk Position Sense pediatric berg balance scale, endurance will be assessed using six-minute walk test (6MWT)

Detailed Description
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This study aims to evaluate the effectiveness of dynamic orthotic garment (Thera togs) on foot pressure distribution, postural control, functional performance and endurance in children with spastic diplegic cerebral palsy (CP). Methods: forty children with spastic diplegic CP, with ages ranging from 8 to 10 years, will be assigned randomly into two groups. The control group will receive the conventional physical therapy, whereas the study group will receive the same program as the control group in addition to Thera togs. Measurement of foot pressure distribution will be performed using a pressure platform, postural control will be evaluated using the trunk control measurement scale ,Trunk Position Sense , pediatric berg balance scale, endurance will be assessed using six-minute walk test (6MWT)

Official Title
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Effect of Dynamic Orthotic Garment on Foot Pressure Distribution, Postural Control, Functional Performance and Endurance in Spastic Diplegic Cerebral Palsy Children: Randomized Controlled Trial

Conditions
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Diplegic Cerebral Palsy

Intervention / Treatment
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* Other: Routine Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children with CP who have toe-in gait and had grade 1+ to 2 degree of spasticity according to the Modified Ashworth Scale (MAS) [32]. In addition to score I and II on Gross Motor Function Classification System (GMFCS) scores [33]. As well as the child is required to be able to stand and walk independently. Exclusion Criteria: Children who have impaired hearing or vision, previous lower limb surgery or Botulinum injections of the lower limb muscles within the preceding 6 months will be excluded from the study.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br>conventional physical therapy based on neurodevelopmental techniques, This program will be given for 1 hour, 3 days a week for 12 weeks | Other: Routine Physical Therapy<br>* Routine physical therapy and orthosis<br>* Other names: Experimental: Intervention group;|
| Experimental: study group<br>conventional physical therapy and orthosis (Thera togs) : the child will wear the orthosis for twelve weeks, from 8 to 10 hours a day, during daily-life activities. The child's guardian (mother) will be trained and will receive a DVD recording, with a step-by-step demonstration on the fitting of TheraTogs® in the child. Markings were made in TheraTogs® to facilitate and improve fitting. All necessary support will be offered, with weekly monitoring in person to control the fitting of the orthosis, as well as for possible questions or clarifications.in addition to conventional physical therapy as the control group | Other: Routine Physical Therapy<br>* Routine physical therapy and orthosis<br>* Other names: Experimental: Intervention group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot pressure distribution | Static and dynamic planter pressure measurements to measure peak and mean plantar pressure for each sub-region of the foot (forefoot, mid-foot and rear-foot) expressed in kPa. | baseline | 
| Foot pressure distribution | Static and dynamic planter pressure measurements to measure peak and mean plantar pressure for each sub-region of the foot (forefoot, mid-foot and rear-foot) expressed in kPa. | Twelve week | 
| The trunk control measurement scale | to assess the static and dynamic components of trunk control.The minimum score is 1 and the maximum scor is 58.Higher score means better outcome | baseline | 
| The trunk control measurement scale | to assess the static and dynamic components of trunk control .The minimum score is 1 and the maximum scor is 58.Higher score means better outcome | Twelve week | 
| Trunk Position Sense | Active position sense of the trunk was assessed using a digital goniometer. | baseline | 
| Trunk Position Sense | Active position sense of the trunk was assessed using a digital goniometer. | Twelve weeks | 
| Pediatric balance scale | The Pediatric balance scale, used to determine the dynamic balancing abilities of children with cerebral palsy, shows an excellent inter-rater reliability.The minimum score is 1 and the maximum score is 56.Higher score means better outcome | baseline | 
| Pediatric balance scale | The Pediatric balance scale, used to determine the dynamic balancing abilities of children with cerebral palsy, shows an excellent inter-rater reliability.The minimum score is 1 and the maximum score is 56.Higher score means better outcome | Twelve weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-minute walk test (6-MWT) | distance covered during six minutes will be recorded | baseline | 
| Six-minute walk test (6-MWT) | distance covered during six minutes will be recorded | Twelve weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Theratog, postural control, cerebral palsy