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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-25
SponsorUniversity of Copenhagen

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Music Motion GroupExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Number of daily logins to the tablet app

Attendance will be measured as the number of times participants log into the tablet app during the intervention. Unit of Measure: Number of logins

Time frame
The app stores the data during the intervention period and will be collected at 12 weeks (end of intervention period)
2

Daily session duration recorded in the tablet app

Adherence will be assessed by the average length of each daily training session. This outcome reflects how long participants remain engaged with the motor training program once they log in. Unit of Measure: Minutes

Time frame
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)
3

Time spent moving the targeted extremity during training recorded in the tablet app

This measure reflects adherence by quantifying the active movement time of the trained extremity during each training session. Unit of Measure: Minutes

Time frame
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)
4

Time spent within target movement intensity threshold recorded in the tablet app

For participants in the Music Motion Feedback group, adherence will also be evaluated by measuring the time spent at or above a predefined movement intensity threshold. Unit of Measure: Minutes

Time frame
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)

Other outcomes

1

The Canadian Occupational Performance Measure (Self-Rated Performance)

During a semi-structured interview, participants identify an activity they want, need, or are expected to perform and set one long-term goal. They then rate their performance of that activity on a 0-10 scale, where 0 = not able to perform the activity at all and 10 = able to perform it extremely well. Unit of Measure: Performance score (0-10 scale)

Time frame
Before baseline (at the motor training program design), at 12 weeks (end of intervention), and at 24 weeks (long-term follow-up)
2

The Canadian Occupational Performance Measure (Self-Rated Satisfaction)

In the same semi-structured interview, participants rate their satisfaction with their performance of the selected activity on a 0-10 scale, where 0 = not satisfied at all and 10 = extremely satisfied. Unit of Measure: Satisfaction score (0-10 scale)

Time frame
Before baseline (at the motor training program design), at 12 weeks (end of intervention), and at 24 weeks (long-term follow-up)
3

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

Time spent walking will be measured using 3-axis accelerometer and gyroscope data collected from seven IMUs worn continuously for 72 hours. Data will be analyzed using a validated deep-learning neural network (Novosel et al., 2023) to classify walking behavior. Unit of Measure: Minutes per day

Time frame
Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
4

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

Standing time will be extracted from IMU data collected during 72 hours of wear. Signals will be analyzed via a validated deep-learning neural network (Novosel et al., 2023) Time Frame: Baseline, 12 weeks, and 24 weeks Unit of Measure: Minutes per day

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

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