Cerebral PalsyTHRIVE-CPNCT06962618
Home-Based Training With Feedback to Improve Outcomes in Adolescents and Young Adults With Cerebral Palsy..
A study testing Music Motion Group in people with Cerebral Palsy, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Music Motion Group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2025to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
CP Youth Clinic, Copenhagen University Hospital - Rigshospitalet
Copenhagen
Jakob Lorentzen, Professor, jlorentzen@sund.ku.dk
About this study
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.
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:
Read more
- 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
- Being tested
- Music Motion Group, Control
- Keywords
- cerebral palsy, Home-based training, Extrinsic feedback, Movement behavior, Motor learning
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Motion GroupBehavioural
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.
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Music Motion Group | Experimental | Not described Receives: Behavioral: Music Motion Group |
| Control | Active comparator | Not described Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Attendance will be measured as the number of times participants log into the tablet app during the intervention.
Unit of Measure: Number of logins
Measured: 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
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
Measured: 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
This measure reflects adherence by quantifying the active movement time of the trained extremity during each training session.
Unit of Measure: Minutes
Measured: 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
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
Measured: 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)
In participants engaged in upper extremity training, the ARAT will be used to evaluate upper extremity functional capacity. It consists of 19 items assessing grasp, grip, pinch, and gross movement. Scores range from 0 to 57, with higher scores indicating better arm function.
Time Frame: Baseline, 12 weeks (end of intervention), and 24 weeks (follow-up) Unit of Measure: ARAT total score (0-57)
Measured: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
Maximum isometric arm strength - (Upper Extremity)
Participants engaged in upper extremity training will have the isometric strength of the targeted upper extremity measured using a handheld dynamometer. They will perform maximum voluntary contractions against resistance, and the peak force will be recorded.
Unit of Measure: Kilograms of force (kgf)
Measured: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
Maximum grip strength - (Upper Extremity)
Participants who are engaged in upper extremity training will have their grip strength of the targeted upper limb measured using a hand dynamometer. The highest of three attempts will be recorded.
Unit of Measure: Kilograms of force (kgf)
Measured: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
Gross Motor Function Measure-66 (GMFM-66) total score - (Lower Extremity)
In participants who are engaged in lower extremity training the GMFM-66 will be used to assess gross motor function. It evaluates activities such as standing, walking, and running. Scores range from 0 to 100, with higher scores indicating better function.
Unit of Measure: GMFM-66 total score (0-100)
Measured: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
Maximum isometric leg strength - (Lower Extremity)
The isometric strength of the trained leg will be assessed using a handheld dynamometer. Participants will perform maximum voluntary contractions, and peak force will be recorded.
Unit of Measure: Kilograms of force (kgf)
Measured: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
Distance walked during the Six-Minute Walk Test (6MWT) - (Lower Extremity)
The 6MWT will be used to evaluate walking endurance and aerobic capacity. Participants engaged in lower extremity training will walk as far as possible in six minutes along a flat, indoor course.
Time Frame: Baseline, 12 weeks, and 24 weeks Unit of Measure: Meters walked
Measured: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Superiority trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ivana Bardino Novosel, University of Copenhagen
- Investigators
- Jakob Lorentzen, Professor, Study director, University of Copenhagen and University Hospital Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962618
- Sponsor's protocol ID
- THRIVE-CP
- Acronym
- THRIVE-CP
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06962618
- Acronym / sponsor ID
- THRIVE-CP / THRIVE-CP
- Conditions
- Cerebral Palsy
- Keywords
- cerebral palsy, Home-based training, Extrinsic feedback, Movement behavior, Motor learning
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Superiority trial
| Arm | Type | Receives |
|---|---|---|
| Music Motion Group | Experimental | Behavioral: Music Motion Group |
| Control | Active comparator | Behavioral: Control |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music Motion GroupParticipants 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. | Behavioural | Music Motion Group |
| ControlParticipants 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. | Behavioural | Control |
Primary outcome
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
Time frame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
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.
10 secondary outcomes
Number of daily logins to the tablet app
Time frame: 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
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)
Time spent moving the targeted extremity during training recorded in the tablet app
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)
Time spent within target movement intensity threshold recorded in the tablet app
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)
Action Research Arm Test (ARAT) total score - (Upper Extremity)
Time frame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
Maximum isometric arm strength - (Upper Extremity)
Time frame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
Maximum grip strength - (Upper Extremity)
Time frame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
Gross Motor Function Measure-66 (GMFM-66) total score - (Lower Extremity)
Time frame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
Maximum isometric leg strength - (Lower Extremity)
Time frame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
Distance walked during the Six-Minute Walk Test (6MWT) - (Lower Extremity)
Time frame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jakob Lorentzen, Professor study director
University of Copenhagen and University Hospital Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Motion Group in people with Cerebral Palsy, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivana B Novosel, PhD student (27328961 ext. +45, ivana.novosel@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline, at 12 weeks (end of intervention period), and at 24 weeks (long term follow up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.