Effect of the Intensive Intervention "Hand-Arm Bimanual Intensive Therapy Including Lower Extremities" (HABIT-ILE) in Chronic (> 6 Months) Adults With Acquired Brain Damage (Stroke)
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 试验地点
- 2
- 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, the possible changes induced by the intensive treatment program "Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)" will be studied in functional, everyday life activities and neuroplastic assessment of adults with chronic stroke.
详细描述
Using a randomized controlled trial design, the possible changes in neuroimaging, motor function, motor learning and everyday life activities of adults with chronic stroke (> 6 months) after participating of the intensive treatment programme "Hand-arm Bimanual Intensive Therapy Including Lower Extremities" (HABIT-ILE) will be studied. Changes, scored by participants in case of questionnaires and by experts in the case of tests, will be observed comparing participants after their regular care/treatment and after receiving HABIT-ILE. Motor function, learning and daily life activities will be correlated with neuroplastic changes.
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
- 40 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hemiparetic patient with a chronic stroke (over 6 months of evolution)
- •age 40 to 90 years old inclusive
- •ability to follow instructions and complete testing according to the age.
排除标准
- •alcohol/drug abuse
- •pregnancy
- •major cognitive impairment interfering with the study (severe aphasia, psychiatric conditions)
- •uncontrolled health issues (cardiac/renal failure)
- •contraindications to perform MRI assessments (Metal implants, etc.)
结局指标
主要结局
Changes on the Adult Assisting Hand Assessment Stroke (Ad-AHA Stroke)
时间窗: baseline, 3 weeks and 13 weeks after baseline
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 on speed/accuracy trade-off during a bimanual reaching task (bi-SAT)(baseline, 3 weeks and 13 weeks after baseline)
- Changes on bimanual coordination during a bimanual reaching task (bi-CO)(baseline, 3 weeks and 13 weeks after baseline)
- Changes on errors during a bimanual reaching task (bi-error)(baseline, 3 weeks and 13 weeks after baseline)
- Changes in finger force tracking dexterity(baseline, 3 weeks and 13 weeks after baseline)
- Changes on the visuospatial short term working memory assessed by the "Corsi block-tapping test"(baseline, 3 weeks and 13 weeks after baseline)
- Changes on bimanual smoothness during a bimanual reaching task (bi-smoothness)(baseline, 3 weeks and 13 weeks after baseline)
- Changes in Fractional Anisotropy (FA) of the corticospinal tract from the motor cortex to the cerebellar peduncle(baseline, 3 weeks and 13 weeks after baseline)
- Changes on the metrics of the corticospinal tract from the motor cortex to the cerebellar peduncle using the NODDI model(baseline, 3 weeks and 13 weeks after baseline)
- Changes in multifinger tapping dexterity(baseline, 3 weeks and 13 weeks after baseline)
- Changes on the Axial, Radial and Mean Diffusivity (AD, RD, MD) of the corticospinal tract from the motor cortex to the cerebellar peduncle(baseline, 3 weeks and 13 weeks after baseline)
- Changes on force during a bimanual reaching task (bi-Force)(baseline, 3 weeks and 13 weeks after baseline)
- Changes in upper extremities sensorimotor functions assess by the Fugl-Meyer Assessment (FMA-UE)(baseline, 3 weeks and 13 weeks after baseline)
- Changes in the Six Minutes' Walk Test (6MWT)(baseline, 3 weeks and 13 weeks after baseline)
- Changes in Canadian Occupational Performance Measure (COPM)(baseline, 3 weeks and 13 weeks after baseline)
- Changes in the Stroke Impact Scale (SIS)(baseline, 3 weeks and 13 weeks after baseline)
- Changes in cortical thickness of the brain's gray matter(baseline, 3 weeks and 13 weeks after baseline)
- Changes in brain white matter microstructure (WM-μs) using the Microstructure Fingerprinting model(baseline, 3 weeks and 13 weeks after baseline)
- Changes in unimanual dexterity assessed by the Box & Block test (BBT)(baseline, 3 weeks and 13 weeks after baseline)
- Changes in visual neglect assessed by the Bells Test(baseline, 3 weeks and 13 weeks after baseline)
- Changes in the Montreal Cognitive Assessment (MoCA) test(baseline, 3 weeks and 13 weeks after baseline)
- Changes on the metrics of the corticospinal tract from the motor cortex to the cerebellar peduncle using the DIAMOND model(baseline, 3 weeks and 13 weeks after baseline)
- Changes in resting-state functional connectivity(baseline, 3 weeks and 13 weeks after baseline)
- Changes in upper extremities motor functions assess by the Wolf Motor Function Test (WMFT)(baseline, 3 weeks and 13 weeks after baseline)
- Changes in activities of daily living assessed by ACTIVLIM-Stroke Questionnaire(baseline, 3 weeks and 13 weeks after baseline)
- Changes in the modified Rankin Scale (mRS) for neurologic disability(baseline, 3 weeks and 13 weeks after baseline)
- Changes in executive functions assessed by the Trail Making Test (TMT)(baseline, 3 weeks and 13 weeks after baseline)
- Changes in activities of daily living assessed by ABILHAND Questionnaire(baseline, 3 weeks and 13 weeks after baseline)
- Changes in inhibitory control assessed by the Stroop Color and Word Test (SCWT)(baseline, 3 weeks and 13 weeks after baseline)
- Changes in the Wechsler Adult Intelligence Scale (WAIS-III)(baseline, 3 weeks and 13 weeks after baseline)
