TheraTogs Effects on Balance and Mobility in Cerebral Palsy

NCT07618962 | Not Yet Recruiting

• 1 other identifier: 30253-12/03/2026
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cerebral Palsy; THERATOGS; BALANCE; FUCTIONAL MOBILITY

Keywords

Cerebral Palsy; children; adolescents; balance; functional mobility; TheraTogs

Outcome Measures

Primary Outcomes (3)

• TIMED UP AND GO TEST

  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.

  1 HOUR

• 10 Meter Walk Test (10MWT)

  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.

  1 HOUR

• Pediatric Balance Scale (PBS)

  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.

  1 HOUR

Study Arms (2)

NO GARMENT FIRST, THEN GARMENT

EXPERIMENTAL

Participants will perform three balance and functional mobility assessments, including the Pediatric Balance Scale, Timed Up and Go Test, and 10-Second Sit-to-Stand Test. Following the initial assessment, participants will wear the orthotic garment and repeat the same assessments.

Device: THERATOGS

GARMENT FIRST, THEN NO GARMENT

EXPERIMENTAL

Participants will initially perform the balance and functional mobility assessments while wearing the orthotic garment. After removal of the garment, the Pediatric Balance Scale, Timed Up and Go Test, and 10-Second Sit-to-Stand Test will be repeated under the same conditions.

Device: THERATOGS

Interventions

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.

GARMENT FIRST, THEN NO GARMENT; NO GARMENT FIRST, THEN GARMENT

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of West Attica: lead

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Marina Karachanidi

CONTACT

6971906736; mscphys24003@uniwa.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHYSIOTHERAPIST

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 1, 2026
• Study Start: June 1, 2026
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share