Aha BOOST Arm-hand BOOST Therapy to Enhance Recovery After Stroke: Clinical, Health Economic and Process Evaluation
NCT Number: NCT06517251
Acronym: AHA-BOOST
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: OTHER: Arm-hand BOOST|OTHER: Lower limb BOOST
Sponsor: KU Leuven
Collaborators: Vrije Universiteit Brussel|Jessa Hospital|Revalidatieziekenhuis RevArte|University Hospital, Ghent
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-17
Completion Date: 2027-04
Locations: Revalidatieziekenhuis RevArte, Edegem, Antwerpen, 2650, Belgium|Revalidatiecentrum K7 UZ Gent, Gent, Oost-Vlaanderen, 9000, Belgium

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.

Primary Outcome Measures: 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 Outcome Measures: Fugl-Meyer assessment- upper extremity (FMA-UE), Assessing the domain of upper limb function. The total score ranges from 0-66, where 0 indicates no motor function and 66 indicates intact motor function., 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), Assessing the domain of upper limb capacity. The total score ranges from 0-10 and reflects the number of items a person can execute., Pre-intervention, immediate post-intervention (after 4 weeks of additional therapy), 3 months post-intervention and 12 months post-stroke.|Barthel Index (BI), Assessing the domain of independence. The total score ranges from 0 (indicating total dependence) to 100 (indicating complete independence)., Pre-intervention, immediate post-intervention (after 4 weeks of additional therapy), 3 months post-intervention and 12 months post-stroke.|modified Rankin Scale (mRS), Assessing the domain of independence. mRS is a 7-point ordinal scale ranging from 0(no symptoms) to 6 (death)., Pre-intervention, immediate post-intervention (after 4 weeks of additional therapy), 3 months post-intervention and 12 months post-stroke.|Stroke Impact Scale (SIS), Assessing the domain of participation. For each subcategory, a domain score is calculated, ranging from 0 to 100, with higher scores indicating less impact., Pre-intervention, immediate post-intervention (after 4 weeks of additional therapy), 3 months post-intervention and 12 months post-stroke.|EuroQOL (EQ-5D-5L), Assessing the domain of quality of life. This test compromises five dimensions, each scored on a 5-level scale: no problems, slight problems, moderate problems, severe problems, unable to/extreme problems., Pre-intervention, immediate post-intervention (after 4 weeks of additional therapy), 3 months post-intervention and 12 months post-stroke.
Other Outcome Measures: Total of healthcare services that patients used from inclusion until 12 months post stroke., Following types of health care resource use will be documented and collected by the use of a diary and questionnaire: primary care visits, emergency visits, inpatient stays, outpatient services, From inclusion until 12 months post stroke.|Number and type of medication used by patients from inclusion until 12 months post stroke., The total number and type of medication used by the patients will be documented (number of days taken, dose, and frequency of intake). This data will be collected by using a diary., From inclusion until 12 months post stroke.|The total of transport costs that patient had from inclusion until 12 months post stroke., The total transportation costs a patients incurs for their rehabilitation (including hospital visits, rehabilitation sessions,...) will be documented in a diary., From inclusion until 12 months post stroke.|Total absence at work that patients experienced due to their stroke., Days away from work due to the stroke will be documented by using a questionnaire., From inclusion until 12 months post stroke.|Number of home modifications that patients had to perform due to their stroke., The total number of home modifications that patients had to perform due to their stroke will be documented using a questionnaire., From inclusion until 12 months post stroke.|Number of equipment and aids that patients have to use due to their stroke., The total number of equipment and aids that patients have to use due to their stroke will be documented using a questionnaire., From inclusion until 12 months post stroke.|Socio-economic status of the participant, The socio-economic status of the participant will be documented using a questionnaire, based on answers about income, education level, employment, and home situation., From inclusion until 12 months post stroke.|Social benefits that participants receive from the government due to their stroke, The social benefits participants receive from the government will be documented (e.g. sickness leave payments) by using a questionnaire., From inclusion until 12 months post stroke.|Barriers and facilitators for implementation Aha BOOST in a rehabilitation center, This outcome measure will be measured by performing interview with patients, treating therapists and the management involved in the implementation process. And by assembling communities op practice in which the Aha BOOST therapists can give feedback on the ongoing implementation process. The interviews with the patient will be performed immediately after their 4 weeks of Aha BOOST therapy. The interviews with the treating therapists and management will be conducted one year after the first included patient. The community of practices will be held frequently (couple of times a year, depending on the need expressed by the Aha BOOST therapists) and will be held for two years., Between first inclusion and 2 years after first inclusion.|Content of study therapy a patient received (experimental or control therapy), The content of the study therapy will be collected by using therapy diaries. Those diaries will be collected during each therapy session for two years., Between first inclusion and 2 years after first inclusion.|Content of usual care therapy a patient received, The content of the usual care therapy will be collected by using therapy diaries. Those diaries will be collected during each therapy session for two years., Between first inclusion and 2 years after first inclusion.|Quality of the Aha BOOST therapy, The quality of the Aha BOOST therapy will be assessed by filming 2 therapy session of the Aha BOOST therapy per Aha BOOST patient. Observation schemes will be used to assess these videos on quality. These videos will be made during Aha BOOST therapy sessions for two years., Between first inclusion and 2 years after first inclusion.