Effects of HABIT-ILE in Adults with Bilateral Cerebral Palsy

Официальное название

Effects of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Adults with Bilateral Cerebral Palsy

Обзор

This randomized controlled trial (RCT) aims to evaluate the effects of intensive Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in improving body structure, function, daily activities, and participation outcomes among adults with cerebral palsy.

Подробное описание

This randomized controlled trial (RCT) will investigate the impact of two weeks of HABIT-ILE therapy versus conventional rehabilitation on spinal, muscular, and functional outcomes in adults (18-50 years old) with bilateral cerebral palsy (CP). Key assessments will include changes in gross motor function, spinal and muscular adaptations assessed via EMG and ultrasound, strength testing, clinical motor function tests, pain assessment, and questionnaires on activity and participation. This study aims to provide a comprehensive analysis of HABIT-ILE's effects especially on motor function, daily life activities and participation across a wide range of age.

Вмешательства

• Поведенческое Hand and Arm Bimanual Intensive Therapy Including Lower Extremities
  The HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) program is an intensive rehabilitation therapy designed to improve motor functions and promote functional independence. Participants in this arm will engage in 6.5 hours of structured activities per day for two weeks (10 days). The therapy focuses on bimanual coordination combined with constant stimulation of the trunk and/or lower extremities, using task-oriented exercises tailored to individual goals. Each particip
• Поведенческое Conventional intervention
  Participants in the control group will continue their usual care, which includes conventional physical and occupational therapy, for a duration of two weeks. They will follow their regular therapy schedules without any changes to their routines or treatment habits. This approach ensures that the control group reflects standard rehabilitation practices, allowing for a direct comparison with the intervention group.

Первичные конечные точки

• Changes in Gross Motor Function Measurement (GMFM-66) [Срок оценки: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]

Вторичные конечные точки (12)

• Changes in muscle strength (Biodex System 4 pro®) [Срок оценки: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]
• Changes in muscle strength (Jamar) [Срок оценки: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]
• Changes in muscle range of motion (Biodex System 4 pro®) [Срок оценки: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]
• Changes in neuromuscular command (muscle co-contraction) [Срок оценки: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]
• Changes in unimanual dexterity (Box and Blocks Test - BBT) [Срок оценки: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]
• Changes in the 2-Minutes' Walk Test (2MWT) [Срок оценки: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]
• Changes in spinal function (electromyography - EMG) [Срок оценки: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]
• Changes in pain perception (Quantitative Sensory Testing - QST) [Срок оценки: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]
• Changes in daily pain perception (Ecological Moment Assessment) [Срок оценки: Pre-intervention (1 week before), during intervention (camp or control period), post-intervention (1 week after), 3 months follow-up]
• Changes in severity of pain (Brief Pain Inventory - Short Form - BPI-SF) [Срок оценки: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]
• Changes in neuropathic pain (PROMIS PQ-Neuro) [Срок оценки: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]
• Changes in perception of pain (Pain Catastrophizing Scale - PCS) [Срок оценки: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up]

Критерии участия

Критерии включения

• Diagnosed bilateral cerebral palsy,
• Adults aged 18 to 50 years old,
• Level of manual ability : level I to V of MACS
• Level of gross motor function : level I to IV of GMFCS
• Ability to follow instructions and complete testing,
• Ability to walk 10 meters independently without human assistance (technical aids such as orthoses or walking aids are permitted).

Критерии исключения

• Unstable seizure
• Programmed botulinum toxin or orthopedic surgery in the 6 months before the intervention, during intervention period or 6 months after the intervention time
• Alcohol/drug abuse
• Pregnancy
• Severe visual or cognitive (severe aphasia, psychiatric conditions) impairments likely to interfere with intervention or testing session completion
• Uncontrolled health issues (cardiac, metabolic...)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• Faculté des Sciences de la Motricité (UCLouvain) — Louvain-la-Neuve

Идентификаторы

NCT: NCT06767930 · B403201316810i

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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