Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Exploring the Efficacy of Combined Task-Specific and Cognitive Strategy Training in Subacute Stroke: A Phase II Clinical Trial.
Brief Summary: Novel stroke rehabilitation approaches, such as task-specific training (TST), have shown promise in improving stroke recovery components such as basic mobility and activities of daily living; however, evidence suggests these improvements are not generalized and transferred to home, community, or work settings, and usually do not impact overall participation outcomes. Further, these treatments are very intense, with total treatment times as high as 30 to 60 hours, making them clinically or economically unfeasible in many settings. In contrast, approaches incorporating cognitive strategy training have shown great promise to not only improve functional activity performance in people living with stroke, but also to facilitate generalization and transfer beyond the clinical setting, and to do so in 10 to 15 treatment hours. Cognitive Orientation to daily Occupational Performance (CO-OP) is an established treatment approach that uses cognitive strategies in combination with TST. Evidence from other research groups and findings from our own participant interview data indicate that the approach may be even more effective if introduced much earlier in the rehabilitation process, however, CO-OP has not yet been tested in this sub-acute population. Therefore, the specific project goals are: 1. To refine the CO-OP treatment approach for use with people less than three months post stroke; 2. To evaluate, in a Phase II clinical trial, the preliminary efficacy of the refined protocol compared to standard occupational therapy on immediate and longer-term skill performance and participation; 3. To determine effect sizes for power calculations for a future Phase III clinical trial to test the new protocol versus contemporary treatment. The research approach consists of Part 1, Protocol Refinement, and Part 2, Exploratory Phase II Clinical Trial.


Options:
A: Arm Label: animal assisted therapy; Type: EXPERIMENTAL; Interventions: Other: animal assisted therapy | Arm Label: standard therapy; Type: ACTIVE_COMPARATOR; Interventions: Other: standard therapy | Intervention Type: OTHER; Name: animal assisted therapy; Assigned to Arm(s): animal assisted therapy | Intervention Type: OTHER; Name: standard therapy; Assigned to Arm(s): standard therapy
B: Arm Label: CO-OP; Type: EXPERIMENTAL; Interventions: Behavioral: CO-OP | Arm Label: Standard Occupational Therapy; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard Occupational Therapy | Intervention Type: BEHAVIORAL; Name: CO-OP; Assigned to Arm(s): CO-OP | Intervention Type: BEHAVIORAL; Name: Standard Occupational Therapy; Assigned to Arm(s): Standard Occupational Therapy
C: Arm Label: Cognitive training group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Cognitive training | Arm Label: Aerobic exercise training group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Aerobic exercise training | Arm Label: Sequential training group; Type: EXPERIMENTAL; Interventions: Behavioral: Sequential combination of aerobic exercise and cognitive training | Intervention Type: BEHAVIORAL; Name: Cognitive training; Assigned to Arm(s): Cognitive training group | Intervention Type: BEHAVIORAL; Name: Aerobic exercise training; Assigned to Arm(s): Aerobic exercise training group | Intervention Type: BEHAVIORAL; Name: Sequential combination of aerobic exercise and cognitive training; Assigned to Arm(s): Sequential training group
D: Arm Label: CO-OP; Type: EXPERIMENTAL; Interventions: Behavioral: CO-OP | Arm Label: Attention Control; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Attention Control | Intervention Type: BEHAVIORAL; Name: CO-OP; Assigned to Arm(s): CO-OP | Intervention Type: BEHAVIORAL; Name: Attention Control; Assigned to Arm(s): Attention Control

Answer: B