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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Saoussen Layouni, Associate professor
- 电话号码：52785163
- 邮箱：layouni.saoussen@FAMSO.u-sousse.tn
学习地点
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Sousse、突尼斯、4000
- Department of PMR Sousse
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接触：
- saoussen layouni
- 电话号码：52785163
- 邮箱：layouni.saoussen@FAMSO.u-sousse.tn
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The Melbourne Assessment 2 (MA2)
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Spasticity
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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其他研究编号
- Department of PMR Sousse
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