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

NCT ID: NCT06962618

Last Updated: 2025-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2029-02-01

Brief Summary

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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

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Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Superiority trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Statistician

Study Groups

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Music Motion Group

Group Type EXPERIMENTAL

Music Motion Group

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Control

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Ivana Bardino Novosel

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jakob Lorentzen, Professor

Role: STUDY_DIRECTOR

University of Copenhagen and University Hospital Copenhagen, Denmark

Locations

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CP Youth Clinic, Copenhagen University Hospital - Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Central Contacts

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Ivana B Novosel, PhD student

Role: CONTACT

27328961 ext. +45

Jakob Lorentzen, Professor

Role: CONTACT

+4531521131

Facility Contacts

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Jakob Lorentzen, Professor

Role: primary

Other Identifiers

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THRIVE-CP

Identifier Type: -

Identifier Source: org_study_id

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