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Aha BOOST Arm-hand BOOST Therapy to Enhance Recovery After Stroke: Clinical, Health Economic and Process Evaluation

RecruitingNAAges 18 Years - anyAllKU Leuven
NCT06517251 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The overall aim of this study is to establish the clinical- and cost-effectiveness of the arm-hand BOOST therapy when delivered on top of the usual care program in the sub-acute phase post stroke and to perform a process evaluation. In this phase III RCT, 80 patients with stroke will be recruited from two inpatient stroke rehabilitation wards in Belgium and randomized to the experimental group receiving arm-hand BOOST therapy or the control group receiving the L-BOOST intervention, on top of their usual inpatient care program. The arm-hand BOOST program (1 hour/day, 5x/week, 4 weeks) consists of group exercises based on four key aspects, namely neurophysiology, sequences of reaching and grasping, de-weighting of the arm, and orientation of the hand towards objects. Additionally, technology-supported upper limb therapy will be provided two times 30 minutes per week. The L-BOOST intervent

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📋 Eligibility rules (as published)
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.
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What it tests

  • Arm-hand BOOST
  • Lower limb BOOST
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Where

2 sites
Revalidatieziekenhuis RevArte
Edegem, Belgium
Revalidatiecentrum K7 UZ Gent
Ghent, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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