Effects of an HABIT-ILE-Based Intervention in Children With Cerebral Palsy

Sponsor
Universidad Europea de Madrid
Study ID
NCT07506837
Status
Not Yet Recruiting

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Conditions

  • Cerebral Palsy

Eligibility Criteria

Sex
ALL
Age
6 Years - 13 Years
Healthy Volunteers
Not accepted

Interventions

  • HABIT-ILE — BEHAVIORAL
    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.

Study Details

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

Key Dates

First listed
Apr 2, 2026
Start date
Mar 1, 2027
Status verified
Mar 2026
Primary completion
Jul 30, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cerebral 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 participant performance and fatigue prevention strategies.
  • No Intervention: Wait-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.

Primary Outcome Measure

Change in task-related energy expenditure during low-intensity functional activity [ Time Frame: Baseline, 15 days after, 6 months after ]

Central Contacts

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