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RECRUITINGINTERVENTIONAL

Implementation of a HABIT-ILE Intervention at Home for Chronic Stroke

Implementation of a HABIT-ILE Intervention at Home for Individuals With Chronic Stroke: a Non-inferiority Randomized Controlled Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study will use a randomized controlled trial design to assess the possible difference between two intensive treatment programs: a classic "Hand and Arm Bimanual Intensive Therapy Including Lower Extremities" (HABIT-ILE) therapy and a HABIT-ILE therapy implemented at the patient's home. Moreover, this study also aims to assess whether the patient's abilities are better with follow-up than without follow-up after two weeks of HABIT-ILE therapy. The possible difference between the therapies will be studied in terms of functional capacities, activities and social participation.

Who May Be Eligible (Plain English)

Who May Qualify: - Adults with a chronic stroke (older than 6 months) - Ability to interact and understand simple instructions in order to complete assessments and therapy - Ability to perform a partial shoulder flexion or abduction, a partial elbow extension, and hold an object in the paretic hand - Availability of a caregiver for 6h30 per day during two weeks of therapy Who Should NOT Join This Trial: - Non controlled seizure - Botulinum toxin injection in the last 6 months before the first assessment or during the therapy - Intensive therapy in the last 6 months before the first assessment or during the therapy - Surgery that could affect the assessments or therapy in the last 6 months before the first assessment or during the therapy - Severe visual or cognitive impairments interfering with treatment and or assessments Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Adults with a chronic stroke (older than 6 months) * Ability to interact and understand simple instructions in order to complete assessments and therapy * Ability to perform a partial shoulder flexion or abduction, a partial elbow extension, and hold an object in the paretic hand * Availability of a caregiver for 6h30 per day during two weeks of therapy Exclusion Criteria: * Non controlled seizure * Botulinum toxin injection in the last 6 months before the first assessment or during the therapy * Intensive therapy in the last 6 months before the first assessment or during the therapy * Surgery that could affect the assessments or therapy in the last 6 months before the first assessment or during the therapy * Severe visual or cognitive impairments interfering with treatment and or assessments

Treatments Being Tested

BEHAVIORAL

Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) implemented at the patient home

The HABIT-ILE therapy at home will follow the same principles as the classic HABIT-ILE. The therapy will take place in the patient's home and a close person (caregiver) will accompany the patient during the therapy. A device will be used to facilitate the implementation of home therapy. Supervision of the therapeutic process will be done remotely by a team of trained supervisors. One hour of remote supervision per day will be scheduled within 6.5 hours of therapy.

BEHAVIORAL

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

HABIT-ILE ("Hand-Arm Bimanual Intensive Therapy including Lower Extremities") is an intensive therapy that continuously incorporates postural control and LE function. This motor learning-based approach include specificity of the practice, motivation, shaping of the task, intensive blocks of training and Hands-Off. Moreover, the therapy is goal-oriented to increase functional independence during daily living.

BEHAVIORAL

Follow-up Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) at the patient's home

HABIT-ILE follow-up at home follow the same principles as classic HABIT-ILE but is delivered at the patient home with 1 hour per day (4 hours per week in autonomy and 1 hour per week under supervision).

BEHAVIORAL

Usual care

Usual care is all the weekly physiotherapy and occupational therapy sessions that the patient usually receives.

Locations (1)

MSL-IN lab, IoNS, UCLouvain
Brussels, Belgium