The THRIVE-CP Trial - Targeted Home-Based Training With Real-Time Feedback to Improve Versatile Movement Behaviors and Enhance Outcomes in Adolescents and Young Adults With Cerebral Palsy: Protocol for a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Percentage change in daytime movement of the trained extremity (right or left arm or leg) as measured by 3-axis accelerometer and gyroscope data analyzed via deep-learning neural network
研究概览
简要总结
This clinical trial aims to determine whether extrinsic feedback through music enhances the effects of home-based motor training for adolescents and young adults with cerebral palsy (CP) and whether feedback improves adherence to the training program.
The main questions it aims to answer are:
- Does extrinsic feedback improve real-world movement more than home training alone?
- Do participants receiving extrinsic feedback adhere more closely to their training program?
To determine its effectiveness, the investigators will compare home-based training with and without real-time music feedback.
Participants will:
- Engage in a home-based motor training program for 12 weeks, tailored to their individual needs and goals.
- Receive real-time music feedback during training or no feedback (control group).
- Attend weekly virtual coaching sessions to discuss short-term goals and training progress.
- Undergo movement assessments before training, at 12 weeks (T2) and 24 weeks (T3).
- Wear movement sensors for 72 hours at T2 and T3 to track real-world movement behavior.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Statistician
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of cerebral palsy
- •Sensorimotor deficits in at least one limb
- •Demonstrated motivation to develop or regain motor skills, indicated by the expression of specific goals
- •Ability to follow instructions independently or with caregiver support
- •Ability to provide informed consent
排除标准
- •Diagnosis of dyskinetic cerebral palsy
- •Presence of significant health risks that could interfere with participation
- •Surgery or first Botox injection within one month before the trial or during the trial period
研究组 & 干预措施
Music Motion Group
干预措施: Music Motion Group (Behavioral)
Control
干预措施: Control (Behavioral)
结局指标
主要结局
Percentage change in daytime movement of the trained extremity (right or left arm or leg) as measured by 3-axis accelerometer and gyroscope data analyzed via deep-learning neural network
时间窗: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
Movement data will be collected using seven Inertial Measurement Units (IMUs) worn continuously for 72 hours at three time points: baseline, 12 weeks (end of intervention), and 24 weeks (follow-up). IMUs will be attached to the sternum, wrists, thighs, and lower legs using adhesive patches and will capture 3-axis accelerometer and gyroscope data. A validated custom neural network (Novosel et al. 2023) will convert signals into images and analyze them using convolutional layers to extract features related to movement behaviors. The primary metric will be the percentage change (minutes a day) in real-world daytime movement of the trained limb, computed relative to baseline. This outcome reflects changes in functional mobility resulting from the motor training intervention.
次要结局
- Number of daily logins to the tablet app(The app stores the data during the intervention period and will be collected at 12 weeks (end of intervention period))
- Daily session duration recorded in the tablet app(The app stores the data during the intervention period and will be collectedThe app stores the data during the intervention period and will be collected at 12 weeks (end of intervention period))
- Time spent moving the targeted extremity during training recorded in the tablet app(The app stores the data during the intervention period and will be collected The app stores the data during the intervention period and will be collected at 12 weeks (end of intervention period))
- Time spent within target movement intensity threshold recorded in the tablet app(The app stores the data during the intervention period and will be collected The app stores the data during the intervention period and will be collected at 12 weeks (end of intervention period))
- Action Research Arm Test (ARAT) total score - (Upper Extremity)(Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up))
- Maximum isometric arm strength - (Upper Extremity)(Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up))
- Maximum grip strength - (Upper Extremity)(Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up))
- Gross Motor Function Measure-66 (GMFM-66) total score - (Lower Extremity)(Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up))
- Maximum isometric leg strength - (Lower Extremity)(Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up))
- Distance walked during the Six-Minute Walk Test (6MWT) - (Lower Extremity)(Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up))
研究者
Ivana Bardino Novosel
Principal Investigator
University of Copenhagen