Clinical trial NCT04664673: HABIT-ILE in Adults With Chronic Stroke (HABIT-ILE Stroke)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: University Hospital of Mont-Godinne
First posted: 2020-12-11
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Allocation
Primary purpose: TREATMENT

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.

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.)

Primary outcomes:
measure: Changes on the Adult Assisting Hand Assessment Stroke (Ad-AHA Stroke)
timeFrame: baseline, 3 weeks and 13 weeks after baseline
Secondary outcomes:
measure: Changes on speed/accuracy trade-off during a bimanual reaching task (bi-SAT)
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes on force during a bimanual reaching task (bi-Force)
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes on bimanual coordination during a bimanual reaching task (bi-CO)
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes on bimanual smoothness during a bimanual reaching task (bi-smoothness)
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes on errors during a bimanual reaching task (bi-error)
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes in finger force tracking dexterity
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes in multifinger tapping dexterity
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes in cortical thickness of the brain's gray matter
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes in Fractional Anisotropy (FA) of the corticospinal tract from the motor cortex to the cerebellar peduncle
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes on the Axial, Radial and Mean Diffusivity (AD, RD, MD) of the corticospinal tract from the motor cortex to the cerebellar peduncle
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes on the metrics of the corticospinal tract from the motor cortex to the cerebellar peduncle using the NODDI model
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes on the metrics of the corticospinal tract from the motor cortex to the cerebellar peduncle using the DIAMOND model
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes in resting-state functional connectivity
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes in brain white matter microstructure (WM-μs) using the Microstructure Fingerprinting model
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes in upper extremities sensorimotor functions assess by the Fugl-Meyer Assessment (FMA-UE)
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes in upper extremities motor functions assess by the Wolf Motor Function Test (WMFT)
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes in unimanual dexterity assessed by the Box & Block test (BBT)
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes in the Six Minutes' Walk Test (6MWT)
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes in Canadian Occupational Performance Measure (COPM)
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes in the Stroke Impact Scale (SIS)
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes in activities of daily living assessed by ACTIVLIM-Stroke Questionnaire
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes in activities of daily living assessed by ABILHAND Questionnaire
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes in the modified Rankin Scale (mRS) for neurologic disability
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes in visual neglect assessed by the Bells Test
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes on the visuospatial short term working memory assessed by the "Corsi block-tapping test"
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes in the Montreal Cognitive Assessment (MoCA) test
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes in inhibitory control assessed by the Stroop Color and Word Test (SCWT)
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes in executive functions assessed by the Trail Making Test (TMT)
timeFrame: baseline, 3 weeks and 13 weeks after baseline
measure: Changes in the Wechsler Adult Intelligence Scale (WAIS-III)
timeFrame: baseline, 3 weeks and 13 weeks after baseline
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institute of Neuroscience, UCLouvain
Study officials:
affiliation: Institute of Neuroscience, UCLouvain; CHU-UCL Namur, Neurology Department, UCLouvain
name: Yves Vandermeeren, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MSL-IN Lab, Institute of Neuroscience, UCLouvain
name: Yannick Bleyenheuft, PhD
role: PRINCIPAL_INVESTIGATOR
References: