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临床试验/NCT04664673
NCT04664673Unknown不适用

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)

Université Catholique de Louvain2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2020年12月15日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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