TheraTogs Effects on Balance and Mobility in Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Balance Brain Damage, Chronic Brain Diseases Central Nervous System Diseases FUCTIONAL MOBILITY Nervous System Diseases THERATOGS

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of unilateral or bilateral spastic Cerebral Palsy
GMFCS level I or II
MAS level lower than +1
Ability to understand and follow instructions
Ability to walk without assistive devices

Exclusion criteria

Use of medications affecting balance
Hearing or visual impairments
Intellectual disability
Botulinum toxin (Botox) injection in the lower limbs within the previous 6 months
Severe musculoskeletal deformities
Surgery within the previous 6 months
Uncontrolled seizures during the previous 6 months

Treatment and study plan

THERATOGS

Device

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.

Primary outcomes

TIMED UP AND GO TEST

Time frame: 1 HOUR

The Timed Up and Go (TUG) test evaluates functional mobility. The test requires a chair with armrests and back support, a measuring tape, adhesive tape, and a stopwatch. The time required for the participant to stand up from the chair, walk a distance of three meters (with or without assistive devices), turn around, return, and sit down again is recorded. The TUG test is considered a valid and highly reliable tool (ICC = 0.99) for evaluating functional mobility in children with CP.
10 Meter Walk Test (10MWT)

Time frame: 1 HOUR

The 10 Meter Walk Test (10MWT) evaluates functional mobility by measuring walking speed. Participants walk at their normal pace along a 14-meter walkway with or without assistive devices. A stopwatch is used to record the time required to complete a 10-meter distance, excluding the first and last two meters to allow for acceleration and deceleration. The test demonstrates high test-retest reliability and high correlation with gross motor function in children with CP.
Pediatric Balance Scale (PBS)

Time frame: 1 HOUR

The Pediatric Balance Scale (PBS) is a modified version of the Berg Balance Scale designed to assess functional balance skills in children with mild to moderate motor impairments. The scale consists of 14 balance-related items scored from 0 (lowest function) to 4 (highest function), with a maximum score of 56 and a minimum score of 0 . The PBS has been translated into Greek and is considered a reliable and valid tool for assessing functional balance in children with CP.

Study contacts

Contact information is provided by the study sponsor or research team.

Marina Karachanidi

CONTACT

[email protected]

6971906736 ext. +30

Sponsors and collaborators

Lead sponsor

University of West Attica

Other

Registry information

Official study 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

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jun 1, 2026
Registry last updated: Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed