Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy.
Virtual Reality-Augmented Constraint-Induced Movement Therapy Versus Conventional Constraint-Induced Therapy for Upper Limb Rehabilitation in Children With Unilateral Cerebral Palsy: A Randomized Controlled Trial.
Cerebral palsy (CP) causes persistent motor and postural impairments that can limit children's functional independence and participation. Upper-limb rehabilitation traditionally relies on conventional therapies, while Virtual Reality (VR) provides an immersive, engaging environment that can improve motor function and quality of life. Constraint-Induced Movement Therapy (CIMT) promotes intensive use of the affected upper limb and has demonstrated benefits in motor and functional outcomes. Recent evidence suggests that combining VR with CIMT (VRCIT) may further improve upper-limb function, hand manipulation, and dexterity. However, in Tunisia, access to CIMT and VR-based rehabilitation remains limited, and no Tunisian study has yet evaluated the effectiveness of VRCIT in children with unilateral CP, highlighting an important research gap.
Aim: Evaluate the effectiveness of Virtual Reality-Augmented Constraint-Induced Movement Therapy and constraint-induced movement therapy only in improving unimanual upper limb function in children with unilateral cerebral palsy.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Saoussen Layouni, Associate professor
- 전화번호: 52785163
- 이메일: layouni.saoussen@FAMSO.u-sousse.tn
연구 장소
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Sousse, 튀니지, 4000
- Department of PMR Sousse
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연락하다:
- saoussen layouni
- 전화번호: 52785163
- 이메일: layouni.saoussen@FAMSO.u-sousse.tn
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Able to handle objects in daily life within levels I, II and III on the Gross Motor Function Classification System.
- Absence of musculoskeletal disorders that impaired the ability of children to use the VR system.
- Normal or corrected hearing and vision.
- Able to understand and follow simple directions and perform requested tasks.
- Tutor Consent.
Exclusion Criteria:
- Dizziness during VR sessions.
- Intolerance to VR environments.
- Unable to continue or follow the CIMT or VR program.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: 30 children between 5 to 14 years diagnosed with spastic hemiplegic cerebral palsy.
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All participants will undergo two assessment sessions, one at baseline and one at the end of the program. Clinical testing will consist of physical examination, assessing unimanual function through the Melbourne Assessment 2 (MA2), unilateral gross manual dexterity (The Box and blocks Test), spasticity through the Modified Ashworth Scale (MAS) for elbow and wrist, muscle strength grading (MRC), upper limb passive range of motion (PROM), and bimanual ability through ABILHANDS-KIDS questionnaire. The clinical outcome measures will be recorded by a researcher-resident in physical medicine and rehabilitation. After obtaining the oral consent of the participants' legal guardians, those who met the inclusion criteria will be divided in two groups: The first group will receive a CIMT program, the second group will undergo a VRCIT based-rehabilitation program, both for a period of two weeks. A clinical evaluation will be performed one day before the program. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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The Melbourne Assessment 2 (MA2)
기간: before and immediately after the intervention
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The Melbourne Assessment 2 (MA2) is a standardized assessment tool used to evaluate the quality of unilateral (one-sided) upper limb function in children with neurological impairments. It focuses on assessing the range of movement, accuracy, dexterity, and fluency of the child's upper limb during specific tasks. It reports a child's performance as four separate percentage scores corresponding to each measured element of movement quality. |
before and immediately after the intervention
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Spasticity
기간: before and immediately after intervention
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Spasticity through the Modified Ashworth Scale (MAS) for elbow and wrist ranging from 0 (normal tone) to 4 (rigid). |
before and immediately after intervention
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Muscle strength
기간: before and immediately after intervention
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Muscle strength grading (MRC) ranging from 0 (no muscle activation) to 5 (normal muscle strength with full power against maximal resistance and a complete range of motion). |
before and immediately after intervention
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Passive Range of Motion
기간: before and immediately after intervention
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Upper limb passive range of motion (PROM) in degrees measured with a goniometer. |
before and immediately after intervention
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The Box and Blocks Test
기간: before and immediately after intervention
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Unilateral gross manual dexterity (The Box and blocks Test) for the affected limb scored by counting the total number of blocks safely transferred from one compartment to the other in 60 seconds (number of blocks per minute). |
before and immediately after intervention
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ABILHANDS-KIDS questionnaire
기간: before and immediately after intervention
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Bimanual ability to manage daily life activities through ABILHANDS-KIDS questionnaire ranging from 0 to 42, with each task is assessed as "easy", "difficult" or "impossible". Raw scores are converted through a psychometric analysis (Rasch model) into a linear measure in logits on a continuous scale. Higher score: Indicates a better manual ability and greater independence in daily life activities requiring the use of both hands. Lower score: Reveals a significant activity limitation and an increased need for assistance in personal care. |
before and immediately after intervention
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- Department of PMR Sousse
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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