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

Recruiting now · Not applicable

Conditions studied: Stroke

In brief

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 intervention comprises a dose-matched program of lower limb exercises and general reconditioning. At baseline, after 4 weeks of training, 3 months after the intervention and at 12 months post stroke, outcome assessment will be performed. The primary outcome measure is the action research arm test (ARAT). Secondary outcomes include measures in the domain of upper limb function and capacity, independence, participation and quality of life. Multivariate ANOVA and sensitivity analyses will be used to compare change from baseline between groups. Information on medical costs will be collected to allow a health economic evaluation. Finally, a process evaluation will be performed to assist in identifying why arm-hand BOOST succeeds or fails unexpectedly or has unanticipated consequences, and how this can be optimized. At the start of this study the investigators hypothesize that: (I) Aha BOOST will result in a significant greater improvement in arm-hand activity post-intervention, at follow-up and 12 months post stroke compared to control therapy (L-BOOST); (II) Aha BOOST will result in a significant greater improvement in upper limb function, performance, independence and activity of daily living, and participation post-intervention, at follow up and 12 months post stroke. (III) Investing in 24 hours of extra arm-hand therapy to subacute stroke patient in the inpatient rehabilitation setting can reduce the health-economic and societal cost 12 months post stroke.

Key facts

Study ID

NCT06517251

Run by

KU Leuven

People needed

80

Starts

2024-06-17

Expected to finish

2027-12-01

Last updated by the study team

2026-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Revalidatieziekenhuis RevArte — Edegem, Antwerpen, Belgium (enrolling)
• Revalidatiecentrum K7 UZ Gent — Ghent, Oost-Vlaanderen, Belgium

Full record on ClinicalTrials.gov

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