NCT06767930尚未招募不适用
Effects of Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in Adults with Bilateral Cerebral Palsy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in Gross Motor Function Measurement (GMFM-66)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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...)
研究组 & 干预措施
HABIT-ILE
Experimental
干预措施: Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (Behavioral)
Conventional intervention
Active Comparator
干预措施: Conventional intervention (Behavioral)
结局指标
主要结局
Changes in Gross Motor Function Measurement (GMFM-66)
时间窗: pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up
Measurement of change in gross motor function over time in adults with cerebral palsy.
次要结局
- Changes in daily pain perception (Ecological Moment Assessment)(Pre-intervention (1 week before), during intervention (camp or control period), post-intervention (1 week after), 3 months follow-up)
- Changes in muscle strength (Biodex System 4 pro®)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
- Changes in muscle strength (Jamar)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
- Changes in muscle range of motion (Biodex System 4 pro®)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
- Changes in neuromuscular command (muscle co-contraction)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
- Changes in unimanual dexterity (Box and Blocks Test - BBT)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
- Changes in the 2-Minutes' Walk Test (2MWT)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
- Changes in spinal function (electromyography - EMG)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
- Changes in pain perception (Quantitative Sensory Testing - QST)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
- Changes in severity of pain (Brief Pain Inventory - Short Form - BPI-SF)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
- Changes in neuropathic pain (PROMIS PQ-Neuro)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
- Changes in perception of pain (Pain Catastrophizing Scale - PCS)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
- Changes in coping strategies (Coping Strategies Questionnaire - CSQ-F)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
- Changes in coping strategies (General Self-Efficacy Scale - GSES)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
- Changes in daily activities (Canadian Occupational Performance Measure - COPM)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
- Changes in daily activities (ABILHAND Questionnaire)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
- Changes in daily activities (ACTIVLIM-CP Questionnaire)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
- Changes in daily activities (ABILOCO questionnaire)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
- Changes in participation (Participation in Life Situation Questionnaire - PILS)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
- Changes in psychological well-being (Hospital Anxiety and Depression Scale - HADS)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
- Changes in pain and sleeping (Pain and Sleep Questionnaire 3 - PSQ-3)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
- Changes in fatigue (Multidimensional Fatigue Inventory - MFI)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
- Changes in quality of life (WHOQOL-BREF)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
- Changes in cognitive function (PROMIS Neuro-QOL Short Form Cognitive Function 2.0)(pre-intervention (1 week before), post-intervention (1 week after), 3 months follow-up)
研究者
Yannick Bleyenheuft
Professor
Université Catholique de Louvain
研究点 (1)
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