NCT07506837

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

Effects of Intensive Motor Control-Based Therapy for Upper and Lower Extremities in Children With Cerebral Palsy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Universidad Europea de Madrid · Academic / Other
• Sex: All
• Age: 6 Years – 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Palsy

Interventions

Type	Name	Description
BEHAVIORAL	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 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.

Timeline

• Start date: 2027-03-01
• Primary completion: 2027-07-30
• Completion: 2028-01-01
• First posted: 2026-04-02
• Last updated: 2026-04-02