Circuit class or seven-day therapy for increasing intensity of rehabilitation after stroke. Protocol of the CIRCIT trial.
Susan Hillier, Coralie English, Professor Maria Crotty, Leonie Segal, Julie Bernhardt, and Adrian Esterman.
Acknowledgements and funding
Conflicts of interest: None to declare
Key words:
Stroke, rehabilitation, therapy, clinical trial
Summary
Rationale There is strong evidence for a dose-response relationship between physical therapy early after stroke and recovery of function. The optimal method of maximizing physical therapy within finite health care resources is unknown.
Aims To determine the effectiveness and cost-effectiveness of two alternative models of physical therapy service delivery (seven-day per week therapy services or group circuit class therapy over five days a week) to usual care for people receiving inpatient rehabilitation after stroke.
Design Multicenter, three-armed randomized controlled trial with blinded assessment of outcomes.
Study A total of 282 people admitted to inpatient rehabilitation facilities after stroke with an admission Functional Independence Measure score within the moderate range (total 40-80 points or motor 38-62 points) will be randomized to receive one of three interventions:
· usual care therapy over five days a week
· standard care therapy over seven-days a week, or
· group circuit class therapy over five days a week.
Participants will receive the allocated intervention for the length of their hospital stay. Analysis will be by intention-to-treat.
Outcomes The primary outcome measure is walking ability (six-minute walk test) at four-weeks post-intervention with three and six-month follow-up. Economic analysis will include a costing analysis based on length of hospital stay and staffing/resource costs and a cost-utility analysis (incremental quality of life per incremental cost, relative to usual care). Secondary outcomes include walking speed and independence, ability to perform activities of daily living, arm function, quality of life and participant satisfaction.
