TheraTogs Effects on Balance and Mobility in Cerebral Palsy

Sponsor
University of West Attica
Study ID
NCT07618962
Status
Not Yet Recruiting

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Conditions

  • BALANCE
  • Cerebral Palsy
  • FUCTIONAL MOBILITY
  • THERATOGS

Eligibility Criteria

Sex
ALL
Age
5 Years - 15 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jun 1, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: NO GARMENT FIRST, THEN GARMENT
    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.
  • Experimental: GARMENT FIRST, THEN NO GARMENT
    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.

Primary Outcome Measure

TIMED UP AND GO TEST [ Time Frame: 1 HOUR ]

Central Contacts

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