TheraTogs Effects on Balance and Mobility in Cerebral Palsy
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
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Marina Karachanidi
- 전화번호: +30 6971906736
- 이메일: mscphys24003@uniwa.gr
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
|
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.
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실험적: 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.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
TIMED UP AND GO TEST
기간: 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.
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1 HOUR
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10 Meter Walk Test (10MWT)
기간: 1 HOUR
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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.
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1 HOUR
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Pediatric Balance Scale (PBS)
기간: 1 HOUR
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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.
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1 HOUR
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
THERATOGS에 대한 임상 시험
-
Technical University of BernMaastricht University종료됨
-
Abant Izzet Baysal University아직 모집하지 않음뇌성마비(CP) | 경직 | 상지 기능 | 손 그립 강도