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

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University of Copenhagen

Status

Begins enrollment in 6 months

Conditions

Cerebral Palsy

Treatments

Behavioral: Music Motion Group
Behavioral: Control

Study type

Interventional

Funder types

Other

Identifiers

NCT06962618
THRIVE-CP

Details and patient eligibility

About

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.

Enrollment

70 estimated patients

Sex

All

Ages

15 to 25 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

70 participants in 2 patient groups

Music Motion Group
Experimental group
Treatment:
Behavioral: Music Motion Group
Control
Active Comparator group
Treatment:
Behavioral: Control

Trial contacts and locations

1

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Central trial contact

Ivana B Novosel, PhD student; Jakob Lorentzen, Professor

Data sourced from clinicaltrials.gov

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