Implementation of a HABIT-ILE Intervention at the William Lennox Neurological Centre for Sub-acute Adult Post-stroke Patients (<6 Mois): a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Changes on the Adult Assisting Hand Assessment Stroke (Ad-AHA Stroke)
研究概览
简要总结
Using a randomized controlled trial design, in an hospital environment, possible changes induced by the "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" treatment program will be investigated in functional activities of daily living, motor and cognitive assessment of patients with sub-acute post-stroke
详细描述
The aim is to investigate, for the first time, the effectiveness of HABIT-ILE therapy in a hospital setting in the treatment of a population representative of the clinical population for adult patients with subacute stroke.
The hypothesis is that an in-hospital HABIT-ILE protocol will be more effective than conventional therapies usually given to patients with sub-acute post-stroke, and that this difference will be objectively demonstrated by clinical assessments of motor function, cognition and participation conducted before and after treatment periods.
The aim of the study is therefore to evaluate the effect of intensive bimanual hand-arm therapy including the lower extremities (HABIT-ILE) on body functions and structures, activity and participation in adulte patients suffering from subacute stroke..
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Phase aiguë ou subaiguë
排除标准
- •Epilepsie instable
- •Absence à déterminer sa volonté à participer
- •Traitement toxine pendant le stage
结局指标
主要结局
Changes on the Adult Assisting Hand Assessment Stroke (Ad-AHA Stroke)
时间窗: [Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)]
This assessment is an observation-based instrument assessing the effectiveness of the spontaneous use of the affected hand when performing bimanual activities in adults post stroke scored in a logit based 0-100 AHA-unit scale (higher score indicate higher ability)
次要结局
- Changes in upper extremities sensorimotor functions assess by the Fugl-Meyer Assessment (FMA-UE)([Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)])
- Changes in unimanual dexterity: Box and Blocks test (BBT)([Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)])
- Changes in Canadian Occupational Performance Measure (COPM)([Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)])
- Changes in the Stroke Impact Scale (SIS)([Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)])
- Changes in activities of daily living assessed by ACTIVLIM-Stroke Questionnaire([Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)])
- Changes in activities of daily living assessed by ABILHAND Questionnaire([Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)])
- Changes in visual neglect assessed by the Bells Test([Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)])
- Changes in the Montreal Cognitive Assessment (MoCA) test([Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)])
- Changes in balance control assessed by the mini Balance Evaluation System Test (mini BEST test)([Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)])
- Changes in the Two Minutes' Walk Test (2MWT)([Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)])
- Changes in National Institutes of Health Stroke Scale (NIHSS)([Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)])
- Changes in Tardieu Scale et Modified Tardieu Scale (MTS)([Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up))
- Changes in EQ-5D-5L([Time Frame: T0 (baseline), T1 (after 2weeks intervention), T2(3 months follow-up)])
研究者
Yannick Bleyenheuft
Professor
Université Catholique de Louvain