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Clinical Trial NCT07506837 (UEM-HABITILE) for Cerebral Palsy is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Effects of an HABIT-ILE-Based Intervention in Children With Cerebral Palsy (UEM-HABITILE) 30 Novel Treatment Prevention
Clinical Trial NCT07506837 (UEM-HABITILE) is an interventional study for Cerebral Palsy and is currently not yet recruiting. Enrollment is planned to begin on 1 March 2027 and continue until the study accrues 30 participants. Led by Universidad Europea de Madrid, this study is expected to complete by 1 January 2028. The latest data from ClinicalTrials.gov was last updated on 2 April 2026.
Brief Summary
This interventional study will evaluate the effects of an intensive HABIT-ILE-based camp on cardiorespiratory measures and body composition in children with cerebral palsy. Although intensive motor control-based therapies such as HABIT/HABIT-ILE have shown functional benefits, the novelty of this study is the assessment of energy expenditure during functional tasks and post-intervention changes in body composition. P...Show More
Detailed Description
Children with cerebral palsy frequently present limitations in upper and lower extremity function that affect mobility, daily activities, and participation. Intensive motor control-based approaches, particularly Hand-Arm Bimanual Intensive Therapy (HABIT) and Hand-Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE), have shown functional benefits in this population. In prior HABIT/HABIT-ILE programs,...Show More
Official Title
Effects of Intensive Motor Control-Based Therapy for Upper and Lower Extremities in Children With Cerebral Palsy
Conditions
Cerebral PalsyPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- UEM-HABITILE
- UEM-HABITILE-CAMP
NCT ID Number
Start Date (Actual)
2027-03-01
Last Update Posted
2026-04-02
Completion Date (Estimated)
2028-01-01
Enrollment (Estimated)
30
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Cerebral Palsy
HABIT-ILE
Body Composition
Energy Expenditure
HABIT-ILE
Body Composition
Energy Expenditure
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalCerebral palsy HABIT-ILE Intensive therapy Pediatric rehabilitation Bimanual training Functional mob Children with cerebral palsy will participate in a summer camp-format intensive rehabilitation program based on HABIT-ILE principles. The intervention includes upper and lower extremity motor training delivered in a playful, progressive group setting by trained interventionists under professional supervision. The program is administered over 15 days, 6 hours/day (90 total hours), with activities adapted to participan...Show More | HABIT-ILE Participants will receive a 90-hour intensive intervention (6 hours/day for 15 days) in a summer camp format. The intervention includes bimanual upper-limb activities; lower-extremity and mobility training (e.g., walking on different surfaces, treadmill walking, stair negotiation); activity-based strengthening; and whole-body playful activities (e.g., dance and sports games). New technologies (e.g., videogame-based a...Show More |
No InterventionWait-List Control Children with cerebral palsy assigned to the wait-list control group will not receive the intensive HABIT-ILE-based summer camp intervention during the initial study comparison period. They will continue with their usual care and will be offered participation in the camp intervention next year, according to program availability and study logistics. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in task-related energy expenditure during low-intensity functional activity | Change in energy expenditure during low-intensity functional tasks (e.g., comfortable walking), assessed in the physiology laboratory using gas analysis and electrocardiographic monitoring during task performance. | Baseline, 15 days after, 6 months after |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change in body composition | Change in body composition assessed using DEXA at Universidad Europea de Madrid. | Baseline, 15 days after and 6 months after |
Change in manual function (Assisting Hand Assessment, AHA) | Change in effectiveness of use of the affected hand during bimanual performance, assessed with the Assisting Hand Assessment (AHA). | Baseline, 15 days after and 6 months after |
Change in unilateral hand function performance (Jebsen-Taylor Test of Hand Function) | Change in unilateral hand function performance, assessed by time to complete standardized manual tasks using the Jebsen-Taylor Test of Hand Function | Baseline, 15 days after, 6 months after |
Change in walking capacity (6-Minute Walk Test) | Change in unilateral hand function performance, assessed by time to complete standardized manual tasks using the Jebsen-Taylor Test of Hand Function | Baseline, 15 days after and 6 months after |
Change in gait speed (10-Meter Walk Test) | Change in gait speed, assessed by time required to walk 10 meters during the 10-Meter | Baseline, 15 days after and 6 months after |
Change in functional mobility (Timed Up and Go) | Change in functional mobility, assessed by the Timed Up and Go test (time required to stand up, walk, turn, return, and sit down) | Baseline, 15 days after, 6 months after |
Change in gross motor function (GMFM) | Change in gross motor function (GMFM) | Baselilne, 15 days after, 6 months after |
Change in functional balance (Pediatric Balance Scale) | Change in functional balance (Pediatric Balance Scale) | Baseline, 15 days after and 1 month after |
Change in parent-/tutor-reported functional performance (Canadian Occupational Performance Measure, COPM) | Change in parent-/tutor-reported functional performance (Canadian Occupational Performance Measure, COPM) | Baseline, 15 days after, 6 months after |
Change in disability and function (Pediatric Evaluation of Disability Inventory, PEDI) | Change in disability and function (Pediatric Evaluation of Disability Inventory, PEDI) | Baseline, 15 days after, 6 months after |
Change in parent-reported manual ability ABILHAND-Kids) | Change in parent-reported manual ability (ABILHAND-Kids ) | Baseline, 15 days after and 6 months after |
Change in parent-reported locomotion difficulty (ABILOCO-Kids) | Change in parent-reported locomotion difficulty (ABILOCO-Kids) | Baseline, 15 days after and 6 months after |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child
Minimum Age
6 Years
Eligible Sexes
All
- Children with a diagnosis of cerebral palsy (hemiparesis or diparesis).
- Age 6 to 13 years.
- Moderate cognitive impairment or cognitive status compatible with the ability to follow verbal instructions.
- Ability to participate in an intensive summer camp-format rehabilitation program.
- Parent/legal guardian able to provide informed consent and complete parent-/tutor-reported outcome measures.
- Medical or orthopedic condition that contraindicates participation in intensive physical rehabilitation activities.
- Unstable neurological or medical condition (e.g., uncontrolled seizures) that may interfere with safe participation.
- Severe cognitive or behavioral impairment preventing comprehension of basic verbal instructions or safe participation in group activities.
- Contraindication to study assessment procedures, including physiological testing or DEXA body composition assessment.
- Participation in another concurrent intensive rehabilitation program during the study comparison period.
- Any condition that, in the investigators' judgment, may compromise safety, adherence, or outcome assessment validity.
Universidad Europea de MadridStudy Responsible Party
Vanesa Abuín, Principal Investigator, Associate Professor, Universidad Europea de Madrid
Study Central Contact
Contact: Vanesa Abuín, (+34) 912 115 224, [email protected]
No location data.