NCT04664673UnknownNot Applicable
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 sites in 1 country48 target enrollmentStarted: December 15, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Changes on the Adult Assisting Hand Assessment Stroke (Ad-AHA Stroke)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.)
Outcomes
Primary Outcomes
Changes on the Adult Assisting Hand Assessment Stroke (Ad-AHA Stroke)
Time Frame: 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)
Secondary Outcomes
- 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)
Investigators
Study Sites (2)
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