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

Not Applicable

Completed

• Conditions: Down Syndrome
• Interventions: Device: 1- Reciprocal electrical stimulation; Device: TheraTogs orthotic treatment; Procedure: traditional physical therapy program

• Registration Number: NCT05702632
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-15
• Primary Completion: 2022-09-08
• Study First Submitted: 2022-10-27
• Study Completion: 2022-12-30
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-18
• Last Update Submitted: 2023-01-18
• Study First Posted: 2023-01-27
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	traditional physical therapy program	-
Group B	traditional physical therapy program	-
Group A	1- Reciprocal electrical stimulation	-
Group B	TheraTogs orthotic treatment	-

Primary Outcome Measures

Name	Time	Method
postural stability	3 months	overall stability indices had been measured by Biodex balance system

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Giza, Eldoky, Egypt