Home-Based Training With Feedback to Improve Outcomes in Adolescents and Young Adults With Cerebral Palsy..

Sponsor
University of Copenhagen
Study ID
NCT06962618
Status
Not Yet Recruiting

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Conditions

  • Cerebral Palsy

Eligibility Criteria

Sex
ALL
Age
15 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Music Motion Group — BEHAVIORAL
    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.
  • Control — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
May 8, 2025
Start date
Dec 1, 2025
Status verified
Apr 2025
Primary completion
Dec 1, 2028
Completion
Feb 1, 2029

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Music Motion Group
  • Active Comparator: Control

Primary Outcome Measure

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 [ Time Frame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up) ]

Central Contacts

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