Clinical trial NCT06962618: Home-Based Training With Feedback to Improve Outcomes in Adolescents and Young Adults With Cerebral Palsy..
Official title: The THRIVE-CP Trial - Targeted Home-Based Training With Real-Time Feedback to Improve Versatile Movement Behaviors and Enhance Outcomes in Adolescents and Young Adults With Cerebral Palsy: Protocol for a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Keywords: cerebral palsy
Home-based training
Extrinsic feedback
Movement behavior
Motor learning
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 70
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Superiority trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
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
timeFrame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
Secondary outcomes:
measure: Number of daily logins to the tablet app
timeFrame: The app stores the data during the intervention period and will be collected at 12 weeks (end of intervention period)
measure: Daily session duration recorded in the tablet app
timeFrame: 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)
measure: Time spent moving the targeted extremity during training recorded in the tablet app
timeFrame: 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)
measure: Time spent within target movement intensity threshold recorded in the tablet app
timeFrame: 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)
measure: Action Research Arm Test (ARAT) total score - (Upper Extremity)
timeFrame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
measure: Maximum isometric arm strength - (Upper Extremity)
timeFrame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
measure: Maximum grip strength - (Upper Extremity)
timeFrame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
measure: Gross Motor Function Measure-66 (GMFM-66) total score - (Lower Extremity)
timeFrame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
measure: Maximum isometric leg strength - (Lower Extremity)
timeFrame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
measure: Distance walked during the Six-Minute Walk Test (6MWT) - (Lower Extremity)
timeFrame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
Other outcomes:
measure: The Canadian Occupational Performance Measure (Self-Rated Performance)
timeFrame: Before baseline (at the motor training program design), at 12 weeks (end of intervention), and at 24 weeks (long-term follow-up)
measure: The Canadian Occupational Performance Measure (Self-Rated Satisfaction)
timeFrame: Before baseline (at the motor training program design), at 12 weeks (end of intervention), and at 24 weeks (long-term follow-up)
measure: Change in time spent walking per day (as measured by IMUs)
timeFrame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
measure: Change in time spent standing per day (as measured by IMUs)
timeFrame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
measure: Change in time spent sitting per day (as measured by IMUs)
timeFrame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
measure: Change in time spent lying down per day (as measured by IMUs)
timeFrame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
measure: Change in number of posture transitions per day (as measured by IMUs)
timeFrame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
measure: Change in relative extremity usage ratio
timeFrame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
measure: Adverse events
timeFrame: Through week 12 (baseline to end of intervention)
Locations:
city: Copenhagen
country: Denmark
facility: CP Youth Clinic, Copenhagen University Hospital - Rigshospitalet
Study officials:
affiliation: University of Copenhagen and University Hospital Copenhagen, Denmark
name: Jakob Lorentzen, Professor
role: STUDY_DIRECTOR
References: