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

NCT06517251 | Recruiting DMC

• 2 other identifiers: S68329T002323N
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stroke

Keywords

Randomized controlled trial; Upper extremity; Subacute stroke; Inpatient rehabilitation; Additional therapy; Clinical evaluation; Health-economic evaluation; Process evaluation

Outcome Measures

Primary Outcomes (1)

• Action Research Arm Test (ARAT)

  The Action Research Arm Test (ARAT) is the recommended outcome in stroke trials, measuring arm-hand capacity at ICF activity level. The total score ranges from 0 to 57, with higher scores representing better performance.

  Pre-intervention, immediate post-intervention (after 4 weeks of additional therapy), 3 months post-intervention and 12 months post-stroke.

Secondary Outcomes (6)

• Fugl-Meyer assessment- upper extremity (FMA-UE)

  Pre-intervention, immediate post-intervention (after 4 weeks of additional therapy), 3 months post-intervention and 12 months post-stroke.

• Stroke Upper Limb Capacity Scale (SULCS)

  Pre-intervention, immediate post-intervention (after 4 weeks of additional therapy), 3 months post-intervention and 12 months post-stroke.

• Barthel Index (BI)

  Pre-intervention, immediate post-intervention (after 4 weeks of additional therapy), 3 months post-intervention and 12 months post-stroke.

• modified Rankin Scale (mRS)

  Pre-intervention, immediate post-intervention (after 4 weeks of additional therapy), 3 months post-intervention and 12 months post-stroke.

• Stroke Impact Scale (SIS)

  Pre-intervention, immediate post-intervention (after 4 weeks of additional therapy), 3 months post-intervention and 12 months post-stroke.

Other Outcomes (12)

• Total of healthcare services that patients used from inclusion until 12 months post stroke.

  From inclusion until 12 months post stroke.

• Number and type of medication used by patients from inclusion until 12 months post stroke.

  From inclusion until 12 months post stroke.

• The total of transport costs that patient had from inclusion until 12 months post stroke.

  From inclusion until 12 months post stroke.

Study Arms (2)

Arm-hand BOOST (Aha BOOST)

EXPERIMENTAL

Aha BOOST consist of 20 one-hour group sessions (spread over 4 weeks, 5 days a week) and one hour of individual therapy per week (divided in two times 30 minutes). This group will receive therapy for the upper extremity.

Other: Arm-hand BOOST

Lower limb BOOST (L-BOOST)

ACTIVE COMPARATOR

L-BOOST consist of 20 one-hour group sessions (spread over 4 weeks, 5 days a week) and one hour of individual therapy per week (divided in two times 30 minutes). This group will receive therapy for strengthening exercises the lower limbs and general reconditioning.

Other: Lower limb BOOST

Interventions

Arm-hand BOOST OTHER

Aha BOOST consists of 20 one-hour BOOST sessions (spread over 4 weeks, 5 days a week) and one hour of individual technology-supported therapy per week (divided in two times 30 minutes), with the aim to provide intensive, goal-oriented upper limb therapy. The sessions will be executed with a maximum of two participants, under supervision of a trained therapist. The group sessions are focused on four key aspects: neurophysiology, sequences of reaching and grasping, de-weighting of the arm, and orientation of the hand towards objects. The different exercises are tailored to the individual patient, based upon ongoing assessment, discussion within the group of therapists, and individual treatment goals of the patient. Additionally, patients exercise two times 30 minutes per week with the AMADEO® (Tyromotion, Austria), an upper limb robotic device, focusing on finger and hand rehabilitation.

Also known as: Aha BOOST

Arm-hand BOOST (Aha BOOST)

Lower limb BOOST OTHER

L-BOOST consists of 20 one-hour sessions and a personalized two times 30 minutes self-exercise program per week and focused on strengthening exercises for the lower limbs and general reconditioning. During the group sessions, circuit-class training is performed according to a standardized written protocol: 20 minutes of cycling on a sitting bike, 20 minutes of strengthening exercises for muscles around hip and knee (e.g. sit-to-stand training), 10 minutes of knee exercises using quadriceps bench in free swing mode and 10 minutes of leg press exercises. Again, a gradual increase in levels of difficulty is provided. Additionally, each patient receives a self-exercise program (balance; strengthening of foot, knee, and hip muscles; walking exercises), which is executed two times 30 minutes per week under minimal supervision of a therapist. None of the exercises involve the use of the upper limb.

Also known as: L-BOOST

Lower limb BOOST (L-BOOST)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• KU Leuven: lead
• Vrije Universiteit Brussel: collaborator
• Jessa Hospital: collaborator
• Revalidatieziekenhuis RevArte: collaborator
• University Hospital, Ghent: collaborator

Study Sites (2)

Revalidatieziekenhuis RevArte

Edegem, Antwerpen, 2650, Belgium

RECRUITING

Revalidatiecentrum K7 UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

NOT YET RECRUITING

Related Publications (1)

• Cornelis L, Cruycke L, Meyer S, De Smedt A, Fobelets M, Michielsen M, Vander Plaetse M, Putman K, Verheyden G. Additional arm-hand boost therapy (AHA-BOOST) in an inpatient rehabilitation setting during the subacute phase after stroke: protocol for a randomised controlled trial including a clinical, process and health economic evaluation. BMJ Open. 2025 Oct 10;15(10):e093079. doi: 10.1136/bmjopen-2024-093079.

  PMID: 41073121 DERIVED

Related Links

• Project website

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Verheyden Geert, Professor

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geert Verheyden, Professor

CONTACT

+32 16 32 91 16; geert.verheyden@kuleuven.be

Sarah Meyer, Dr.

CONTACT

+32 16 32 83 14; sarah.meyer@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Geert Verheyden

Model Details: Assessor-blinded phase III randomized controlled trial with a parallel design

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 24, 2024
• Study Start: June 17, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available upon publication of the research results, or as soon as possible thereafter.
• Access Criteria: The data will be available via KU Leuven RDR. After publication of the results, the respective data will be made available via a suitable scientific repository, providing the necessary guarantees regarding GDPR compliance (i.e., KU Leuven repository, RDR). The dataset will be under restricted access.

Locations

BE (2)