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Clinical Trials/NCT04664673
NCT04664673
Unknown
Not 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 Louvain1 site in 1 country48 target enrollmentDecember 15, 2020
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Université Catholique de Louvain
Enrollment
48
Locations
1
Primary Endpoint
Changes on the Adult Assisting Hand Assessment Stroke (Ad-AHA Stroke)
Last Updated
3 years ago

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.

Registry
clinicaltrials.gov
Start Date
December 15, 2020
End Date
December 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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)

Study Sites (1)

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