The Critical Period After Stroke Study (CPASS) Upper Extremity Treatment Protocol

Abstract

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.

Keywords: Clinical Trials as topic; Occupational therapy; Rehabilitation; Stroke rehabilitation; Upper extremity.

Fig 1

Essential elements of the treatment protocol. Schematic of the essential elements of the treatment protocol used in the CPASS trial. The 4 specific shaping procedures used to deliver the treatment are presented in the middle of the figure and the strategies used to for their operationalization are in the gray circles.

Fig 2

Process to deliver the treatment protocol. Schematic of the dynamic, iterative process used to deliver the CPASS treatment protocol. A standardized and individualized approach was designed that accounted for the therapist and participant factors that gave rise to a highly collaborative therapeutic process. The double-headed arrows reflect the fluidity between each and all steps.

Fig 3

Identification of shaping tasks from an ACS activity. Example of how one ACS instrumental activity, “taking out the trash,” was broken down into sub-categories and shaping tasks from a top-down, hierarchical approach after observation of task performance and collaboration between the therapist and participant. The sub-categories were deconstructed into shaping tasks that targeted a specific UE joint and motion impairment. Of note, the activity sub-categories and tasks varied across participants based on their individual goals and UE problems.

Fig 4

Adapted CORSORT diagram of the per-protocol analysis. CONSORT diagram from the CPASS trial that has been adapted for this analysis. In the CPASS RCT, participants in 3 of the 4 study groups received an additional 20 hours of UE motor training initiated at ≤30 days (acute), 2-3 months (subacute), or ≥6 months (chronic) poststroke. In this per-protocol analysis, participants were excluded if they completed ≤15 hours of CPASS treatment within 42 days of their treatment start date. The boxes with red outlines toward the bottom of the figure highlight the participants excluded from the per-protocol analysis. Excluded participants were from the acute (n=3) and chronic (n=1) study groups. The acute group participants were unable to complete the study-related treatment due to factors unrelated to the treatment and the chronic participant withdrew from the study after baseline assessments. The number of participants included in the pre-protocol analysis from each of the study groups are presented in the gray boxes at the bottom of the figure.

Fig 5

Percentage of total session hours delivered at the different locations. Each bar shows the percentage of session hours delivered at the inpatient rehabilitation facility (IRF), skilled nursing facility (SNF), outpatient research lab, or the participants’ home for the study groups. NOTE. Subacute participants received zero hours at the IRF and 0.5% of total session hours were delivered at a SNF.

Fig 6

Percentage of total session hours training across the 5 activity domains. Each bar shows, as a percent, the total session hours spent by the acute, subacute, and chronic groups training activities within the different domains including ADLs, instrumental, low-demand leisure, high-demand leisure, and social domains of the ACS.