Cerebral Palsy
Conditions
Keywords
Cerebral Palsy, HABIT-ILE, Body Composition, Energy Expenditure
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. Participants will attend a summer camp-format intervention delivering 90 hours of upper and lower extremity training over 15 days (6 hours/day), supervised by trained rehabilitation staff in a playful, progressive group setting. The program includes bimanual activities, gait and stair tasks, functional strengthening, and whole-body games, with fatigue prevention strategies.Assessments will be performed at baseline and immediately after the camp in July 2027, with follow-up at 6 months (January 2028). Outcomes include functional performance, parent-reported function, low-intensity task-related energy expenditure measured in a physiology laboratory, and body composition measured by DEXA at Universidad Europea de Madrid
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, improvements in upper limb function have been reported, and benefits may persist over time after the intervention. In addition to motor impairment, children with cerebral palsy may be especially vulnerable to sedentary behavior and related health consequences. The present study is based on the rationale that intensive whole-body functional training may improve not only motor performance but also physiological efficiency during functional tasks. The main novelty of this study is not the intervention format itself, but the evaluation of task-related energy expenditure and post-intervention body composition changes after an intensive HABIT-ILE-based summer camp.This study will implement a summer camp-format intensive intervention in children with cerebral palsy, modeled on previously implemented intensive camp experiences. Participants will receive 90 hours of therapy over 15 days (6 hours/day), delivered by trained interventionists (physiotherapists, occupational therapists, supervised students, and volunteers under professional supervision). The intervention will include bimanual upper limb activities; lower extremity and mobility training (e.g., walking on different surfaces, treadmill walking, stair negotiation); functional strengthening through activity-based tasks; and whole-body playful activities (e.g., dance and sports games), with progressive difficulty tailored to each child's performance. Activities will be delivered in small groups (approximately 4-6 children) to promote motivation and peer interaction, and the program will be organized to prevent excessive fatigue.Outcome assessments will include functional measures for upper and lower extremity performance and parent-/tutor-reported functional perception. The protocol also includes low-intensity task-related energy expenditure assessment using physiological monitoring (gas analysis and electrocardiographic monitoring during functional tasks such as comfortable walking) in the physiology laboratory, and body composition assessment using DEXA at Universidad Europea de Madrid. Assessments will be performed at baseline and immediately after the camp in July 2027, with follow-up assessments at 6 months (January 2028). To improve measurement consistency, pre/post testing will be performed by the same evaluator, and test sessions may be recorded for review; the evaluator is intended to be blinded to the intervention.
Interventions
BEHAVIORALHABIT-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 activities and robot-assisted activities) may be incorporated within a participatory and progressively challenging framework. The intervention will be delivered in small groups (approximately 4 to 6 children) by trained physiotherapists, occupational therapists, supervised students, and volunteers. The intervention schedule will be planned to avoid excessive fatigue.
Sponsors
Universidad Europea de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in task-related energy expenditure during low-intensity functional activity | Baseline, 15 days after, 6 months after | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body composition | Baseline, 15 days after and 6 months after | Change in body composition assessed using DEXA at Universidad Europea de Madrid. |
| Change in manual function (Assisting Hand Assessment, AHA) | Baseline, 15 days after and 6 months after | Change in effectiveness of use of the affected hand during bimanual performance, assessed with the Assisting Hand Assessment (AHA). |
| Change in unilateral hand function performance (Jebsen-Taylor Test of Hand Function) | Baseline, 15 days after, 6 months after | Change in unilateral hand function performance, assessed by time to complete standardized manual tasks using the Jebsen-Taylor Test of Hand Function |
| Change in walking capacity (6-Minute Walk Test) | Baseline, 15 days after and 6 months after | Change in unilateral hand function performance, assessed by time to complete standardized manual tasks using the Jebsen-Taylor Test of Hand Function |
| Change in gait speed (10-Meter Walk Test) | Baseline, 15 days after and 6 months after | Change in gait speed, assessed by time required to walk 10 meters during the 10-Meter |
| Change in functional mobility (Timed Up and Go) | Baseline, 15 days after, 6 months after | Change in functional mobility, assessed by the Timed Up and Go test (time required to stand up, walk, turn, return, and sit down) |
| Change in gross motor function (GMFM) | Baselilne, 15 days after, 6 months after | Change in gross motor function (GMFM) |
| Change in functional balance (Pediatric Balance Scale) | Baseline, 15 days after and 1 month after | Change in functional balance (Pediatric Balance Scale) |
| Change in parent-/tutor-reported functional performance (Canadian Occupational Performance Measure, COPM) | Baseline, 15 days after, 6 months after | Change in parent-/tutor-reported functional performance (Canadian Occupational Performance Measure, COPM) |
| Change in disability and function (Pediatric Evaluation of Disability Inventory, PEDI) | Baseline, 15 days after, 6 months after | Change in disability and function (Pediatric Evaluation of Disability Inventory, PEDI) |
| Change in parent-reported manual ability ABILHAND-Kids) | Baseline, 15 days after and 6 months after | Change in parent-reported manual ability (ABILHAND-Kids ) |
| Change in parent-reported locomotion difficulty (ABILOCO-Kids) | Baseline, 15 days after and 6 months after | Change in parent-reported locomotion difficulty (ABILOCO-Kids) |
Contacts
CONTACTVanesa Abuín
Outcome results
None listed