Home-based intensive therapy for chronic stroke recovery
Implementation of a HABIT-ILE Intervention at Home for Individuals With Chronic Stroke: a Non-inferiority Randomized Controlled Trial
This study is testing whether a home-based therapy for stroke recovery works as well as traditional therapy to help people regain their movement and independence.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Université Catholique de Louvain Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT05727111 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of two intensive treatment programs for chronic stroke patients: traditional Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) and a home-based version of the same therapy. It employs a randomized controlled trial design to compare the functional capacities, activities, and social participation of participants receiving these therapies. The study also investigates the impact of follow-up sessions after two weeks of therapy on patient outcomes. By focusing on motor skill learning, the intervention aims to enhance the autonomy of stroke survivors in daily activities.
Who should consider this trial
Good fit: Ideal candidates are adults with chronic stroke who can follow simple instructions and have a caregiver available for therapy sessions.
Not a fit: Patients with severe cognitive or visual impairments, uncontrolled seizures, or recent intensive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the functional independence and quality of life for chronic stroke patients.
How similar studies have performed: Preliminary data from other studies suggest that similar intensive therapies have shown promising results in improving outcomes for stroke patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Brussels
- MSL-IN lab, IoNS, UCLouvain — Brussels, Belgium (Recruiting)
Study contacts
- Principal investigator: Yannick Bleyenheuft, Phd, Prof. — Université Catholique de Louvain
- Study coordinator: Yannick Bleyenheuft, Phd, Prof.
- Email: yannick.bleyenheuft@uclouvain.be
- Phone: +32 486 91 99 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.