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

Launched by KU LEUVEN · Jul 18, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new therapy called arm-hand BOOST to see if it can help people recover better after having a stroke. The aim is to find out if this therapy, when added to the usual care, can improve the use of the arm and hand, increase independence, and enhance overall quality of life for patients in the weeks following their stroke. The study will involve 80 patients who are within five months of experiencing their first stroke. To participate, individuals must be at least 18 years old, have some movement difficulties in their arm, and be able to sit up independently.

Participants in the study will be randomly assigned to either the arm-hand BOOST therapy group or a control group receiving a different form of therapy focused on leg exercises. The arm-hand BOOST program includes group exercises and technology-supported therapy for one hour a day, five days a week, for four weeks. Throughout the study, researchers will assess how well the therapies work by looking at improvements in arm and hand function, overall independence, and quality of life at several points, including after the therapy and one year later. Additionally, the study will gather information about the costs associated with these therapies to see if the investment in this extra treatment is worthwhile.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.