Effects of an HABIT-ILE-Based Intervention in Children With Cerebral Palsy (UEM-HABITILE)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Behavioral: HABIT-ILE

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vanesa Abuín; Phone Number: (+34) 912 115 224; Email: vanesa.abuin@universidadeuropea.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.

What is the study measuring?

Primary 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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidad Europea de Madrid

Publications and helpful links

General Publications

• Charles J, Gordon AM. Development of hand-arm bimanual intensive training (HABIT) for improving bimanual coordination in children with hemiplegic cerebral palsy. Dev Med Child Neurol. 2006 Nov;48(11):931-6. doi: 10.1017/S0012162206002039.
• Gordon AM, Schneider JA, Chinnan A, Charles JR. Efficacy of a hand-arm bimanual intensive therapy (HABIT) in children with hemiplegic cerebral palsy: a randomized control trial. Dev Med Child Neurol. 2007 Nov;49(11):830-8. doi: 10.1111/j.1469-8749.2007.00830.x.
• Gordon AM, Hung YC, Brandao M, Ferre CL, Kuo HC, Friel K, Petra E, Chinnan A, Charles JR. Bimanual training and constraint-induced movement therapy in children with hemiplegic cerebral palsy: a randomized trial. Neurorehabil Neural Repair. 2011 Oct;25(8):692-702. doi: 10.1177/1545968311402508. Epub 2011 Jun 23.
• Bleyenheuft Y, Dricot L, Gilis N, Kuo HC, Grandin C, Bleyenheuft C, Gordon AM, Friel KM. Capturing neuroplastic changes after bimanual intensive rehabilitation in children with unilateral spastic cerebral palsy: A combined DTI, TMS and fMRI pilot study. Res Dev Disabil. 2015 Aug-Sep;43-44:136-49. doi: 10.1016/j.ridd.2015.06.014. Epub 2015 Jul 13.
• Bleyenheuft Y, Arnould C, Brandao MB, Bleyenheuft C, Gordon AM. Hand and Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) in Children With Unilateral Spastic Cerebral Palsy: A Randomized Trial. Neurorehabil Neural Repair. 2015 Aug;29(7):645-57. doi: 10.1177/1545968314562109. Epub 2014 Dec 19.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: March 28, 2026
• First Posted (Actual): April 2, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 28, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Body Composition; Energy Expenditure; HABIT-ILE
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: UEM-HABITILE-CAMP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No