Arm-hand BOOST therapy to improve recovery after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.