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

NCT07506837 | Not Yet Recruiting

• 1 other identifier: UEM-HABITILE-CAMP
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; HABIT-ILE; Body Composition; Energy Expenditure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change in body composition

  Baseline, 15 days after and 6 months after

• Change in manual function (Assisting Hand Assessment, AHA)

  Baseline, 15 days after and 6 months after

• Change in unilateral hand function performance (Jebsen-Taylor Test of Hand Function)

  Baseline, 15 days after, 6 months after

• Change in walking capacity (6-Minute Walk Test)

  Baseline, 15 days after and 6 months after

• Change in gait speed (10-Meter Walk Test)

  Baseline, 15 days after and 6 months after

Study Arms (2)

Cerebral palsy HABIT-ILE Intensive therapy Pediatric rehabilitation Bimanual training Functional mob

EXPERIMENTAL

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

Wait-List Control

NO INTERVENTION

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.

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.

Cerebral palsy HABIT-ILE Intensive therapy Pediatric rehabilitation Bimanual training Functional mob

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Related Publications (5)

• 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.

  PMID: 26183338 BACKGROUND

• 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.

  PMID: 25527487 BACKGROUND

• 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.

  PMID: 21700924 BACKGROUND

• 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.

  PMID: 17979861 BACKGROUND

• 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.

  PMID: 17044964 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Vanesa Abuín

CONTACT

(+34) 912 115 224; vanesa.abuin@universidadeuropea.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: April 2, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share