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

ConditionStroke

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorKU Leuven

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Arm-hand BOOST
Other intervention
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.
Lower limb BOOST
Other intervention
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.

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Arm-hand BOOST (Aha BOOST)Experimental treatment 1 intervention

Group B: Lower limb BOOST (L-BOOST)Active comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame