"Efficacy and Usability of HEMImprove 1.0 Gamified Mobile Application for Upper Limb Rehabilitation in Adolescents With Unilateral Cerebral Palsy: A Randomized Controlled Trial"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 主要终点
- Nine hole Test
研究概览
简要总结
This study aims to evaluate the effectiveness and usability of HEMImprove 1.0, a gamified mobile application designed to improve upper limb motor function in adolescents with unilateral cerebral palsy. Participants will be randomly assigned to an intervention group using the app or a control group performing conventional home exercises. The intervention will last four weeks, with assessments before and after the intervention to measure motor function, motivation, and quality of life improvements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessor will not know the group where the child/adolescent is (experimental or control group)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents aged 12 to 18 years diagnosed with unilateral cerebral palsy.
- •Ability to use the mobile app independently or with minimal assistance.
- •Informed consent provided.
排除标准
- •Severe cognitive impairment.
- •Recent upper limb surgery (within 6 months).
- •Recent botulinum toxin treatment (within 3 months).
- •Other neurological or orthopedic disorders affecting upper limb function.
研究组 & 干预措施
HEMImprove APP
Experimental Group:
Use HEMImprove 1.0 mobile app at home for 30 minutes/session, 5 days/week, for 4 weeks. Exercises tailored progressively with avatar guidance.
Control Group:
Perform conventional home exercises guided by printed manual with instructions and images, matching frequency and duration of intervention group.
干预措施: HEMImprove APP (Other)
Control group
The control group will do exercises for the same time that is described in the experimental group, without using the APP
干预措施: exercises to upper limb (Other)
结局指标
主要结局
Nine hole Test
时间窗: baseline, immediately after the intervention, 3 months after intervention
Melbourne Assessment v 2.0 MA2
时间窗: baseline, immediately after the intervention, 3 months after intervention
Assisting Hand Assessment
时间窗: baseline, immediately after the intervention, 3 months after intervention
次要结局
- User satisfaction and usability measured through structured Likert-scale questionnaires post-intervention.(From the recruitment to the follow-up)
- Qualitative data from semi-structured interviews analyzing user experience.(from the recruitment to the end of the treatment)