NCT05727111Recruiting
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
Source: ClinicalTrials.gov · Last updated 9 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 2 Feb 2023
- Start date
- 1 May 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Université Catholique de Louvain
- Diseases
- Stroke
- NCT number
- NCT05727111
What you commit to
- Study type: Interventional
- Planned participants: 48
- From 1 May 2023 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Non controlled seizure
Other
- Severe visual or cognitive impairments interfering with treatment and or assessments
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MSL-IN lab, IoNS, UCLouvain Coordinator of this site? Confirm its status | Brussels | Belgium | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.