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

NCT06962618 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-05-08

No results posted yet for this study

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.

Conditions

  • Cerebral Palsy

Interventions

BEHAVIORAL

Music Motion Group

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.

BEHAVIORAL

Control

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.

Sponsors & Collaborators

  • University of Copenhagen

    lead OTHER

Principal Investigators

  • Jakob Lorentzen, Professor · University of Copenhagen and University Hospital Copenhagen, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2028-12-01
Completion
2029-02-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06962618 on ClinicalTrials.gov