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Taking people in BelgiumNo phase

Testing an extra arm and hand therapy after stroke in hospital rehabilitation

Tests extra arm and hand exercises in adults recovering from stroke.

Plain-language title generated from the registry record
Registry title: Aha BOOST Arm-hand BOOST Therapy to Enhance Recovery After Stroke: Clinical, Health Economic and Process Evaluation

Key facts

Where
Edegem and Ghent, BelgiumSee the 2 sites

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults in the first 5 months after a first stroke who have weakness in one arm and hand and will stay in hospital rehabilitation for at least 4 more weeks.

Age
18 years or older
Sex
All sexes can join
Disease stage
Maximum 5 months after a first-ever stroke on one side of the brain (unilateral, supra-tentorial). Arm and hand movement is impaired, with a defined Fugl-Meyer upper limb score (stage 2 score of 8-17, or below 8 with a stage 5 hand score above 6).
Earlier treatment
A residual inpatient stay of at least 4 weeks is needed. No other prior treatment is named.

Main reasons for not taking part

  • Severe communication problems (score below 24 out of 32 on the Comprehensive Aphasia Test 'visual sentence comprehension' subscale)
  • Severe thinking and memory problems (score below 18 out of 30 on the Montreal Cognitive Assessment)
  • Not able to sit independently
  • A stroke that was not the first one

Read by machine on 12 November 2026.

Where in Belgium

  • Revalidatieziekenhuis RevArteEdegem, BelgiumContact: Geert Verheyden, ProfessorTaking people
  • Revalidatiecentrum K7 UZ GentGhent, BelgiumContact: Geert Verheyden, ProfessorNot yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
KU Leuven
Trial code
NCT06517251
Record updated
19 March 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: 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.

ClinicalTrials.gov NCT06517251