TheraTogs Effects on Balance and Mobility in Cerebral Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: THERATOGS.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy, THERATOGS, BALANCE, FUCTIONAL MOBILITY. Basic parameters: 5 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
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
Primary outcome measures
- TIMED UP AND GO TEST [Time frame: 1 HOUR]
- 10 Meter Walk Test (10MWT) [Time frame: 1 HOUR]
- Pediatric Balance Scale (PBS) [Time frame: 1 HOUR]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07618962 · 30253-12/03/2026 · 30253-12/03/2026