Circuit class or seven-day therapy for increasing intensity of rehabilitation after stroke: protocol of the CIRCIT trial

Rationale There is strong evidence for a doseresponse 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-days 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 (FIM) 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. Participantswill receivetheallocated interventionfor thelength 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-week postintervention 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.