TheraTogs Versus Reciprocal Electrical Stimulation on Children With Diplegic Cerebral Palsy: a Randomized Controlled Trial

Study Overview
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Brief Summary
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Children with diplegic cerebral palsy exhibit postural restrictions as a result of both primary and secondary brain damage impairments. One of the main goals of cerebral palsy rehabilitation is to improve balance and stability. As a result, the purpose of this study is to compare the effects of TheraTogs and reciprocal electrical stimulation on postural stability in children with diplegic CP.

Official Title
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Comparison of Thera-togs Orthotics With Reciprocal Electrotherapy for Postural Stability in Spastic Diplegic Cerebral Palsy

Conditions
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Down Syndrome

Intervention / Treatment
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* Device: 1- Reciprocal electrical stimulation
* Device: TheraTogs orthotic treatment
* Procedure: traditional physical therapy program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diplegic children of both sexes are between the ages of 8 and 12. The level of spasticity in the lower limbs ranged from grade 1 to grade +1 on the modified Ashworth scale (MAS). The levels of motor function were between levels I and II, according to the Gross Motor Function Classification System (GMFCS). Exclusion Criteria: If they had no major medical issues, according to their medical report. Skin diseases and allergic reactions to the adhesive tape used in this study were excluded, as were any deformities that interfered with lower limb functions, children with pace- makers who were contraindicated by electrical stimula- tion, children with visual, auditory, or perceptual deficits, and children with seizures.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 8 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 |
| --- | --- |
| Active Comparator: Group A<br> | Device: 1- Reciprocal electrical stimulation<br>* A specialized programmable electrical stimulation device was used (Uniphy is the manufacturer of Phyaction787; Uniphy, Eindhoven, the Netherlands). The device has two channels that can alternatively stimulate two opposing groups of muscles (reciprocate).<br>Procedure: traditional physical therapy program<br>* Facilitation of balance and gait training<br>|
| Active Comparator: Group B<br> | Device: TheraTogs orthotic treatment<br>* A sleeveless top vest and two pairs of shorts with two thigh cuffs and limb cuffs each make up the TheraTogs strapping system which is applied to the children in the TheraTogs group. The TheraTogs suit is providing breathable, comfortable- Latex over the torso and thigh, as well as free toileting. For infection control and size fitting problems, participants are not allowed to share their TheraTogs with other patients. TheraTog's orthotic undergarment and strapping system were worn under their regular clothes, so it was neither distracting nor irritating.<br>Procedure: traditional physical therapy program<br>* Facilitation of balance and gait training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postural stability | overall stability indices had been measured by Biodex balance system | 3 months |