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

NCT06962618 | Not Yet Recruiting

• 1 other identifier: THRIVE-CP
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cerebral palsy; Home-based training; Extrinsic feedback; Movement behavior; Motor learning

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)

Secondary Outcomes (10)

• Number of daily logins to the tablet app

  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

  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

  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

  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)

  Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)

Other Outcomes (9)

• The Canadian Occupational Performance Measure (Self-Rated Performance)

  Before baseline (at the motor training program design), at 12 weeks (end of intervention), and at 24 weeks (long-term follow-up)

• The Canadian Occupational Performance Measure (Self-Rated Satisfaction)

  Before baseline (at the motor training program design), at 12 weeks (end of intervention), and at 24 weeks (long-term follow-up)

• Change in time spent walking per day (as measured by IMUs)

  Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)

Study Arms (2)

Music Motion Group

EXPERIMENTAL

Behavioral: Music Motion Group

Control

ACTIVE COMPARATOR

Behavioral: Control

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.

Music Motion Group

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.

Control

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

CP Youth Clinic, Copenhagen University Hospital - Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jakob Lorentzen, Professor

  University of Copenhagen and University Hospital Copenhagen, Denmark

  STUDY DIRECTOR

Central Study Contacts

Ivana B Novosel, PhD student

CONTACT

27328961; ivana.novosel@sund.ku.dk

Jakob Lorentzen, Professor

CONTACT

+4531521131; j.lorentzen@sund.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Superiority trial

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: May 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: May 8, 2025

Record last verified: 2025-04

Locations

DK (1)