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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
Participants will engage in personalized, home-based motor training programs tailored to their individual goals. Each will wear a wireless Inertial Measurement Unit (IMU) on the targeted body part, which transmits movement data via Bluetooth to a tablet app. The training emphasizes task specificity and intensity, with five virtual check-ins to review progress and adjust training parameters. The intervention studied is extrinsic feedback; the app analyzes movement data and provides feedback through music. Before each training session, the app guides participants to set personalized intensity thresholds based on current capacity. When participants meet the intensity threshold, musical elements (e.g., drumbeats, vocals) play. If they fall short, elements drop out, providing knowledge of erroneous performance.
Participants will follow personalized, home-based motor training programs designed like the Music motion group. They will wear a wireless Inertial Measurement Unit (IMU) on the targeted body part, transmitting movement data via Bluetooth to a tablet app. However, unlike the Music Motion Feedback group, participants in the Control group will not receive any extrinsic feedback during their training.
CP Youth Clinic, Copenhagen University Hospital - Rigshospitalet
Copenhagen, Denmark
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
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.
Time frame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
Number of daily logins to the tablet app
Attendance will be measured as the number of times participants log into the tablet app during the intervention. Unit of Measure: Number of logins
Time frame: 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
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: Minutes
Time frame: 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
This measure reflects adherence by quantifying the active movement time of the trained extremity during each training session. Unit of Measure: Minutes
Time frame: 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
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: Minutes
Time frame: 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)
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)
Time frame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
Maximum isometric arm strength - (Upper Extremity)
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)
Time frame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
Maximum grip strength - (Upper Extremity)
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)
Time frame: 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)
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)
Time frame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
Maximum isometric leg strength - (Lower Extremity)
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)
Time frame: 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)
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
Time frame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
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