RESUMO
Objective: To present the development of a novel upper extremity (UE) treatment and assess how it was delivered in the Critical Periods After Stroke Study (CPASS), a phase II randomized controlled trial (RCT). Design: Secondary analysis of data from the RCT. Setting: Inpatient and outpatient settings the first year after stroke. Participants: Of the 72 participants enrolled in CPASS (N=72), 53 were in the study groups eligible to receive the treatment initiated at ≤30 days (acute), 2-3 months (subacute), or ≥6 months (chronic) poststroke. Individuals were 65.1±10.5 years of age, 55% were women, and had mild to moderate UE motor capacity (Action Research Arm Test=17.2±14.3) at baseline. Intervention: The additional 20 hours of treatment began using the Activity Card Sort (ACS), a standardized assessment of activities and participation after stroke, to identify UE treatment goals selected by the participants that were meaningful to them. Treatment activities were broken down into smaller components from a standardized protocol and process that operationalized the treatments essential elements. Main Outcome Measures: Feasibility of performing the treatment in a variety of clinical settings in an RCT and contextual factors that influenced adherence. Results: A total of 49/53 participants fully adhered to the CPASS treatment. The duration and location of the treatment sessions and the UE activities practiced during therapy are presented for the total sample (n=49) and per study group as an assessment of feasibility and the contextual factors that influenced adherence. Conclusions: The CPASS treatment and therapy goals were explicitly based on the meaningful activities identified by the participants using the ACS as a treatment planning tool. This approach provided flexibility to customize UE motor therapy without sacrificing standardization or quantification of the data regardless of the location and UE impairments of participants within the first year poststroke.
RESUMO
INTRODUCTION: Seven hundred ninety-five thousand Americans will have a stroke this year, and half will have a chronic hemiparesis. Substantial animal literature suggests that the mammalian brain has much potential to recover from acute injury using mechanisms of neuroplasticity, and that these mechanisms can be accessed using training paradigms and neurotransmitter manipulation. However, most of these findings have not been tested or confirmed in the rehabilitation setting, in large part because of the challenges in translating a conceptually straightforward laboratory experiment into a meaningful and rigorous clinical trial in humans. Through presentation of methods for a Phase II trial, we discuss these issues and describe our approach. METHODS: In rodents there is compelling evidence for timing effects in rehabilitation; motor training delivered at certain times after stroke may be more effective than the same training delivered earlier or later, suggesting that there is a critical or sensitive period for strongest rehabilitation training effects. If analogous critical/sensitive periods can be identified after human stroke, then existing clinical resources can be better utilized to promote recovery. The Critical Periods after Stroke Study (CPASS) is a phase II randomized, controlled trial designed to explore whether such a sensitive period exists. We will randomize 64 persons to receive an additional 20 h of upper extremity therapy either immediately upon rehab admission, 2-3 months after stroke onset, 6 months after onset, or to an observation-only control group. The primary outcome measure will be the Action Research Arm Test (ARAT) at 1 year. Blood will be drawn at up to 3 time points for later biomarker studies. CONCLUSION: CPASS is an example of the translation of rodent motor recovery experiments into the clinical setting; data obtained from this single site randomized controlled trial will be used to finalize the design of a Phase III trial.
