Home-Based Training With Feedback to Improve Outcomes in Adolescents and Young Adults With Cerebral Palsy..
- Conditions
- Cerebral Palsy
- Registration Number
- NCT06962618
- Lead Sponsor
- University of Copenhagen
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 70
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method 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) Attendance will be measured as the number of times participants log into the tablet app during the intervention.
Unit of Measure: Number of loginsDaily 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) Adherence will be assessed by the average length of each daily training session. This outcome reflects how long participants remain engaged with the motor training program once they log in.
Unit of Measure: MinutesTime 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) This measure reflects adherence by quantifying the active movement time of the trained extremity during each training session.
Unit of Measure: MinutesTime 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) For participants in the Music Motion Feedback group, adherence will also be evaluated by measuring the time spent at or above a predefined movement intensity threshold.
Unit of Measure: MinutesAction Research Arm Test (ARAT) total score - (Upper Extremity) Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up) In participants engaged in upper extremity training, the ARAT will be used to evaluate upper extremity functional capacity. It consists of 19 items assessing grasp, grip, pinch, and gross movement. Scores range from 0 to 57, with higher scores indicating better arm function.
Time Frame: Baseline, 12 weeks (end of intervention), and 24 weeks (follow-up) Unit of Measure: ARAT total score (0-57)Maximum isometric arm strength - (Upper Extremity) Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up) Participants engaged in upper extremity training will have the isometric strength of the targeted upper extremity measured using a handheld dynamometer. They will perform maximum voluntary contractions against resistance, and the peak force will be recorded.
Unit of Measure: Kilograms of force (kgf)Maximum grip strength - (Upper Extremity) Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up) Participants who are engaged in upper extremity training will have their grip strength of the targeted upper limb measured using a hand dynamometer. The highest of three attempts will be recorded.
Unit of Measure: Kilograms of force (kgf)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) In participants who are engaged in lower extremity training the GMFM-66 will be used to assess gross motor function. It evaluates activities such as standing, walking, and running. Scores range from 0 to 100, with higher scores indicating better function.
Unit of Measure: GMFM-66 total score (0-100)Maximum isometric leg strength - (Lower Extremity) Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up) The isometric strength of the trained leg will be assessed using a handheld dynamometer. Participants will perform maximum voluntary contractions, and peak force will be recorded.
Unit of Measure: Kilograms of force (kgf)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) The 6MWT will be used to evaluate walking endurance and aerobic capacity. Participants engaged in lower extremity training will walk as far as possible in six minutes along a flat, indoor course.
Time Frame: Baseline, 12 weeks, and 24 weeks Unit of Measure: Meters walked
Trial Locations
- Locations (1)
CP Youth Clinic, Copenhagen University Hospital - Rigshospitalet
🇩🇰Copenhagen, Denmark