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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое 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 participat

Первичные конечные точки

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

Вторичные конечные точки (12)

• Change in body composition [Срок оценки: Baseline, 15 days after and 6 months after]
• Change in manual function (Assisting Hand Assessment, AHA) [Срок оценки: Baseline, 15 days after and 6 months after]
• Change in unilateral hand function performance (Jebsen-Taylor Test of Hand Function) [Срок оценки: Baseline, 15 days after, 6 months after]
• Change in walking capacity (6-Minute Walk Test) [Срок оценки: Baseline, 15 days after and 6 months after]
• Change in gait speed (10-Meter Walk Test) [Срок оценки: Baseline, 15 days after and 6 months after]
• Change in functional mobility (Timed Up and Go) [Срок оценки: Baseline, 15 days after, 6 months after]
• Change in gross motor function (GMFM) [Срок оценки: Baselilne, 15 days after, 6 months after]
• Change in functional balance (Pediatric Balance Scale) [Срок оценки: Baseline, 15 days after and 1 month after]
• Change in parent-/tutor-reported functional performance (Canadian Occupational Performance Measure, COPM) [Срок оценки: Baseline, 15 days after, 6 months after]
• Change in disability and function (Pediatric Evaluation of Disability Inventory, PEDI) [Срок оценки: Baseline, 15 days after, 6 months after]
• Change in parent-reported manual ability ABILHAND-Kids) [Срок оценки: Baseline, 15 days after and 6 months after]
• Change in parent-reported locomotion difficulty (ABILOCO-Kids) [Срок оценки: Baseline, 15 days after and 6 months after]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07506837 · UEM-HABITILE-CAMP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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