HABIT-ILE in Adults With Chronic Stroke (HABIT-ILE Stroke)

Université Catholique de Louvain

Status: Enrolling

Conditions: Stroke

Treatments: Behavioral: Regular care; Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)

Study type: Interventional

Funder types: Other

Identifiers

NCT04664673

B403201316810h

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

HABIT-ILE

Experimental group

Description:

HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) intervention during two weeks adapted for adults stroke survivors

Treatment:

Behavioral: Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)

Regular care

Active Comparator group

Description:

Usual customary treatment for adults stroke survivors during two weeks

Treatment:

Behavioral: Regular care