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NOT YET RECRUITING
NCT07618962
NA

TheraTogs Effects on Balance and Mobility in Cerebral Palsy

Sponsor: University of West Attica

View on ClinicalTrials.gov

Summary

Cerebral Palsy (CP) is the most common cause of childhood disability, with an estimated prevalence of 17 million individuals worldwide. Children and adolescents with CP present impaired postural control and balance, negatively affecting their mobility and functional performance. The use of dynamic orthotic garments may contribute to the improvement of postural control, balance, and functional mobility in children and adolescents with CP. The aim of the present study is to investigate the immediate effect of the dynamic orthotic garment TheraTogs on balance and functional mobility in children and adolescents with CP. In this cross-sectional pilot study, children and adolescents with CP classified as levels I and II according to the Gross Motor Function Classification System (GMFCS), and with spasticity levels lower than +1 according to the Modified Ashworth Scale, will participate. Balance will be assessed using the Pediatric Balance Scale (PBS), while functional mobility will be evaluated with the Timed Up and Go (TUG) test and the 10 Meter Walk Test (10MWT). Each assessment will be performed twice by each participant, with and without the TheraTogs dynamic orthotic garment, in random order. Statistical analysis will be conducted using SPSS Statistics V29 software, with the level of significance set at p \< 0.05.

Official title: The Effect of the Dynamic Orthotic Garment TheraTogs on Balance and Functional Mobility of Children and Adolescent With Cerebral Palsy: A Cross-Sectional Clinical Study

Key Details

Gender

All

Age Range

5 Years - 15 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-06

Completion Date

2026-06

Last Updated

2026-06-02

Healthy Volunteers

No

Interventions

DEVICE

THERATOGS

Theratogs is a dynamic orthotic garment, made of a "breathable", lightweight, self-adhesive Velcro fabric. It provides a gentle passive force for correcting imbalances or alignments through a combined system of the trunk and lower limbs, along with a system of customized external straps. It is worn over the skin under clothing or over a diaper. The patented soft foam material gently grips the user's soft tissues to create biomechanical changes that are essential for positive outcomes. A variety of lengths, back sizes, stiffness diameters, and placement options optimize the therapeutic and orthotic effects.