HOMe-IMprove Telerrehabilitation System for CHilDren With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- Change in postural control assessed by stabilometric platform
研究概览
简要总结
This pilot study aims to assess the feasibility, adherence, and preliminary efficacy of a home-based telerehabilitation protocol using the HOME Kit Tablet system in children aged 6 to 18 years with cerebral palsy. The study follows a randomized controlled design with parallel groups and single-blind evaluation. The intervention group will use a digitally supervised rehabilitation system, while the control group will follow a traditional home therapy protocol without technological tools.
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)
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of infantile unilateral cerebral palsy
- •Age between 6 and 18 years
- •Stable home Wi-Fi access and space to perform exercises
- •Manual Ability Classification System (MACS) level ≤ 3
- •Informed consent from legal guardian and assent from the child (if <12 years)
排除标准
- •Severe neurological or psychiatric comorbidities
- •Recent orthopedic surgery (<12 months) or botulinum toxin treatment (<6 months)
- •Concurrent participation in other intervention studies
研究组 & 干预措施
HOME Kit Tablet Telerehabilitation
Participants in this arm will receive a structured telerehabilitation program using the HOME Kit Tablet system, which includes a touchscreen tablet with therapeutic software, inertial measurement unit (IMU) sensors, digital scales, a K-wand, and a stabilometric platform. Sessions are remotely supervised in real time by a trained physiotherapist who personalizes the activity protocol according to individual performance.
干预措施: HOME Kit Tablet-based Telerehabilitation (Device)
Conventional Home Physiotherapy
Participants in this arm will follow a conventional home rehabilitation protocol, focusing on upper limb function and postural control. The protocol includes traditional exercises prescribed and explained by a physiotherapist. Follow-up will be conducted through weekly phone calls to reinforce adherence and resolve concerns.
干预措施: Conventional Home Physiotherapy (Other)
结局指标
主要结局
Change in postural control assessed by stabilometric platform
时间窗: baseline, immediately after the intervention, 1 month after intervention
Postural control is evaluated using a stabilometric platform, which quantitatively measures center of pressure (CoP) displacement and sway area during quiet standing. The main outcome is the mean sway area in square centimeters (cm²), with lower values indicating better postural stability.
Change in balance performance assessed by the Pediatric Berg Balance Scale (PBS)
时间窗: baseline, immediately after the intervention, 1 month after intervention
The PBS is a 14-item observational tool designed to measure balance in children. Scores range from 0 to 56; higher scores indicate better balance function.
Change in unimanual hand function assessed by the Assisting Hand Assessment (AHA)
时间窗: baseline, immediately after the intervention, 1 month after intervention
The AHA measures how effectively children with unilateral cerebral palsy use their affected hand in bimanual tasks. Total scores range from 0 to 100; higher scores indicate better hand function.
Change in upper limb performance assessed by the Shriners Hospital for Children Upper Extremity Evaluation (SHUEE)
时间窗: baseline, immediately after the intervention, 1 month after intervention
The SHUEE evaluates spontaneous and dynamic use of the upper limb. Scores range from 0 to 100; higher scores indicate better function.
Change in manual ability assessed by the Children's Hand-use Experience Questionnaire (CHEQ)
时间窗: baseline, immediately after the intervention, 1 month after intervention
The CHEQ is a parent-reported measure that assesses the child's experience using their affected hand in daily tasks. Item scores and mean summary scores; higher scores reflect better experiences.
Change in gross manual dexterity assessed by the Box and Block Test
时间窗: baseline, immediately after the intervention, 1 month after intervention
The Box and Block Test assesses gross manual dexterity by counting the number of blocks moved from one compartment to another in one minute. Higher numbers indicate better manual dexterity.
次要结局
- Change in participation in daily activities assessed by the Participation and Environment Measure for Children and Youth (PEM-CY)(baseline, immediately after the intervention, 1 month after intervention)
- Change in individual goal achievement assessed by Goal Attainment Scaling (GAS)(baseline, immediately after the intervention)
- Change in occupational performance and satisfaction assessed by the Canadian Occupational Performance Measure (COPM)(baseline, immediately after the intervention, 1 month after intervention)
- Change in user satisfaction evaluated with a 5-point Likert-scale questionnaire(immediately after the intervention.)