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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
MSL-IN lab, IoNS, UCLouvain
RECRUITING
Brussels
Contact Information
Primary
Yannick Bleyenheuft, Phd, Prof.
yannick.bleyenheuft@uclouvain.be
+32 486 91 99 11
Backup
Merlin Somville, Phd student
merlin.somville@uclouvain.be
+32 477 08 26 77
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 48
Treatments
Experimental: HABIT-ILE therapy at home with a HABIT-ILE follow-up at home
2 weeks of HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) therapy at home followed by 9 weeks of HABIT-ILE follow-up at home
Experimental: HABIT-ILE therapy at home followed by usual care
2 weeks of HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) therapy at home followed by 9 weeks of usual care
Active_comparator: Classic HABIT-ILE therapy followed by usual care
2 weeks of classic HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) therapy on site followed by 9 weeks of usual care
Active_comparator: Classic HABIT-ILE therapy with HABIT-ILE follow-up at home
2 weeks of classic HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremities) therapy on site followed by 9 weeks of HABIT-ILE follow-up at home
Related Therapeutic Areas
Sponsors
Leads: Université Catholique de Louvain

This content was sourced from clinicaltrials.gov