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Clinical Trial Summary

Abstract

Method: Participants with a diagnosis of stroke will be randomly assigned to the intervention group and the attention control group at a 1:1 ratio. Participants received 2 sessions per week for 12 to 15 sessions.

Outcome measures including the Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D), Canadian Occupational Performance Measure(COPM), Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms, Wisconsin Card Sorting Task (WCST), and Participation Strategies Self Efficacy Scale (PS-SES) will be administered at baseline (T1), post-intervention (T2), 3-month follow-up (T3), 6-month follow-up (T4), and 12-month follow-up (T5).


Clinical Trial Description

The proposed study will examine the efficacy of a newly developed intervention program, the Optimizing Participation after Stroke through Strategy-training (OPASS) program on improving participation in productivity, social activities, and community among community-dwelling people with cognitive impairments after stroke. The OPASS program were developed based on the theoretical tenets of strategy training, with the goal of helping participants to set their participation goals, identify barriers to their performance, develop strategies to address these barriers, and generalize their learning through iterative practice. To examine the efficacy of OPASS, the following objectives will be addressed in this study:

1. To examine whether, compared to a control group, participating in the OPASS program will improve participation in productivity, social, and community domains in stroke survivors with cognitive impairments;

2. To determine whether the changes in participation after the intervention is correlated with changes in applied cognition, daily activities, executive functioning, and self-efficacy.

3. To examine whether the intervention effect sustains at 3-, 6-, and 12-month following the intervention.

To address this purpose, parallel-group randomized controlled trial will be implemented to assess the efficacy of the OPASS program in comparison to the control group. An expected sample of 450 adults with stroke-related cognitive impairments and are undergoing outpatient rehabilitation services will be recruited from our collaborative sites in Northern Taiwan. These participants will be randomly assigned to the intervention group and the attention control group at a 1:1 ratio.

Outcome measures including the Participation Measure- 3 Domains, 4 Dimensions (PM-3D4D), Activity Measure for Post-Acute Care (AMPAC) Outpatient Short Forms, Canadian Occupational Performance Measure(COPM), Wisconsin Card Sorting Task (WCST), and Participation Strategies Self Efficacy Scale (PS-SES) will be administered at baseline (T1), post-intervention (T2), 3-month follow-up (T3), 6-month follow-up (T4), and 12-month follow-up (T5). Data will be analyzed using multiple linear regression models and mixed-effects regression models.

Qualitative in-depth interviews with participants, caregivers, and therapists will be conducted following the intervention. Data regarding the interviewees' experiences, satisfaction, and their perceived effectiveness of the intervention will be collected. Transcribed data will be coded by two independent coders and analyzed with thematic analysis method. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03792061
Study type Interventional
Source Taipei Medical University
Contact Fang Heng Chang
Phone 886-2-2736-1661
Email fhchang@tmu.edu.tw
Status Not yet recruiting
Phase N/A
Start date January 14, 2019
Completion date December 31, 2023

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