Arm-hand BOOST therapy to improve recovery after stroke
Aha BOOST Arm-hand BOOST Therapy to Enhance Recovery After Stroke: Clinical, Health Economic and Process Evaluation
This study is testing if a new arm-hand therapy can help people recovering from a stroke get better faster compared to a standard treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | KU Leuven Academic / other |
| Locations | 2 sites (Edegem, Antwerpen and 1 other locations) |
| Trial ID | NCT06517251 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness and cost-effectiveness of arm-hand BOOST therapy in enhancing recovery for patients in the sub-acute phase after a stroke. Eighty patients will be recruited from two inpatient rehabilitation wards in Belgium and randomly assigned to receive either the arm-hand BOOST therapy or a control intervention, L-BOOST, alongside their usual care. The arm-hand BOOST program includes group exercises focused on neurophysiology, reaching and grasping sequences, de-weighting of the arm, and hand orientation, supplemented by technology-supported therapy. Data will be collected through standardized forms and digital platforms to assess clinical outcomes and process evaluations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced a first-ever unilateral stroke within the last five months and have specific motor impairments in the upper limb.
Not a fit: Patients with severe communication or cognitive deficits may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve upper limb recovery and overall rehabilitation outcomes for stroke patients.
How similar studies have performed: Other studies have shown promise in similar therapeutic approaches, suggesting potential for success in this intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Maximally 5 months after a first-ever unilateral, supra-tentorial stroke * Minimally 18 years old * A residual inpatient stay of minimally 4 weeks * The ability to sit independently * Motor impairment in the upper limb, as defined, based on the JSU diagram, as a score of 8-17 on stage 2 (synergies) of the Fugl-Meyer assessment upper extremity (FMA-UE) or a score of \<8 on stage 2 of the FMA-UE, combined with a score of \>6 on stage 5 (hand) of the FMA-UE. Exclusion Criteria: * Severe communication deficits as defined as a score of \<24 out of 32 on the 'visual sentence comprehension' subscale of the Comprehensive Aphasia Test. * Severe cognitive deficits as defined as a score of \<18 out of 30 on the Montreal Cognitive Assessment.
Where this trial is running
Edegem, Antwerpen and 1 other locations
- Revalidatieziekenhuis RevArte — Edegem, Antwerpen, Belgium (Recruiting)
- Revalidatiecentrum K7 UZ Gent — Ghent, Oost-Vlaanderen, Belgium (Not_yet_recruiting)
Study contacts
- Principal investigator: Verheyden Geert, Professor — KU Leuven
- Study coordinator: Geert Verheyden, Professor
- Email: geert.verheyden@kuleuven.be
- Phone: +32 16 32 91 16
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.