Enhancing community participation for stroke survivors with cognitive impairment: study protocol for a randomised controlled trial in Taiwan

Introduction Stroke can lead to life-long disability and constitutes a huge financial burden on the family and society. Stroke survivors with cognitive impairment often experience considerable challenges in the process of recovery and returning to society. Interventions that effectively help individ...

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Main Authors: Tsan-Hon Liou, Lu Lu, Feng-Hang Chang, Valeria Chiu, Pengsheng Ni, Yen-Nung Lin, Jiunn-Horng Kang, Der-Sheng Han, Elizabeth R Skidmore
Format: Article
Language:English
Published: BMJ Publishing Group 2020-12-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/10/12/e040241.full
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author Tsan-Hon Liou
Lu Lu
Feng-Hang Chang
Valeria Chiu
Pengsheng Ni
Yen-Nung Lin
Jiunn-Horng Kang
Der-Sheng Han
Elizabeth R Skidmore
author_facet Tsan-Hon Liou
Lu Lu
Feng-Hang Chang
Valeria Chiu
Pengsheng Ni
Yen-Nung Lin
Jiunn-Horng Kang
Der-Sheng Han
Elizabeth R Skidmore
author_sort Tsan-Hon Liou
collection DOAJ
description Introduction Stroke can lead to life-long disability and constitutes a huge financial burden on the family and society. Stroke survivors with cognitive impairment often experience considerable challenges in the process of recovery and returning to society. Interventions that effectively help individuals resume essential daily activities and return to active participation in their communities are lacking. This study examines the efficacy of a newly-developed intervention programme, the Optimising Participation after Stroke through Strategy-training (OPASS) programme, for improving community participation among stroke survivors with cognitive impairment.Methods and analysis A single-blind, parallel-group randomised controlled trial with allocation concealment and assessor blinding will be implemented to assess the efficacy of the OPASS programme. An expected 210 adults with cognitive impairment following stroke will be randomly assigned to either the experimental intervention (OPASS) group or the attention control group. In addition to their usual rehabilitation, both groups will receive 45 min sessions, twice weekly for a total of 12–15 sessions. The primary outcome is change in participation performance, which will be measured using the participation measure—three domains, four dimensions scale. Additional measures include the Activity Measure for Post-Acute Care generic outpatient short forms, Montreal Cognitive Assessment, Stroop Test, Trail Making Test and General Self-Efficacy Scale. These scales will be administered at baseline, post-intervention, 3-month follow-up, 6-month follow-up and 12-month follow-up. Their results will be analysed using multiple linear regression models and mixed-effects regression models. Further assessment of feasibility and acceptability of the intervention will be conducted through structured interviews with participants, caregivers and therapists. These interviews will be transcribed and thematically analysed.Ethics and dissemination Ethics approval was obtained from the Ethics Committee of Taipei Medical University (approval number: N201804055). The findings will be disseminated through presentations at scientific conferences and through publication in peer-reviewed journals.Trial registration number NCT03792061; pre-results.
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spelling doaj-art-c8a5cfe26c3a4f7690e92a43737587752025-08-20T02:26:37ZengBMJ Publishing GroupBMJ Open2044-60552020-12-01101210.1136/bmjopen-2020-040241Enhancing community participation for stroke survivors with cognitive impairment: study protocol for a randomised controlled trial in TaiwanTsan-Hon Liou0Lu Lu1Feng-Hang Chang2Valeria Chiu3Pengsheng Ni4Yen-Nung Lin5Jiunn-Horng Kang6Der-Sheng Han7Elizabeth R Skidmore8Department of Physical Medicine and Rehabilitation, Shuang Ho Hospital, Taipei, TaiwanDepartment of General Surgery, Hepatobiliary Surgery Center, Huashan Hospital & Cancer Metastasis Institute, Fudan University, Shanghai, ChinaGraduate Institute of Injury Prevention and Control, College of Public Health, Taipei Medical University, Taipei, TaiwanDepartment of Physical Medicine and Rehabilitation, Taipei Tzu Chi Hospital, Taipei, TaiwanHealth Law, Policy & Management; Biostatistics and Epidemiology Data Analytics Center, Boston University School of Public Health, Boston, Massachusetts, USAGraduate Institute of Injury Prevention and Control, College of Public Health, Taipei Medical University, Taipei, TaiwanResearch Center of Artificial Intelligence in Medicine, Taipei Medical University College of Medicine, Taipei, TaiwanDepartment of Physical Medicine and Rehabilitation, National Taiwan University College of Medicine, Taipei, TaiwanDepartment of Occupational Therapy, University of Pittsburgh, Pittsburgh, Pennsylvania, USAIntroduction Stroke can lead to life-long disability and constitutes a huge financial burden on the family and society. Stroke survivors with cognitive impairment often experience considerable challenges in the process of recovery and returning to society. Interventions that effectively help individuals resume essential daily activities and return to active participation in their communities are lacking. This study examines the efficacy of a newly-developed intervention programme, the Optimising Participation after Stroke through Strategy-training (OPASS) programme, for improving community participation among stroke survivors with cognitive impairment.Methods and analysis A single-blind, parallel-group randomised controlled trial with allocation concealment and assessor blinding will be implemented to assess the efficacy of the OPASS programme. An expected 210 adults with cognitive impairment following stroke will be randomly assigned to either the experimental intervention (OPASS) group or the attention control group. In addition to their usual rehabilitation, both groups will receive 45 min sessions, twice weekly for a total of 12–15 sessions. The primary outcome is change in participation performance, which will be measured using the participation measure—three domains, four dimensions scale. Additional measures include the Activity Measure for Post-Acute Care generic outpatient short forms, Montreal Cognitive Assessment, Stroop Test, Trail Making Test and General Self-Efficacy Scale. These scales will be administered at baseline, post-intervention, 3-month follow-up, 6-month follow-up and 12-month follow-up. Their results will be analysed using multiple linear regression models and mixed-effects regression models. Further assessment of feasibility and acceptability of the intervention will be conducted through structured interviews with participants, caregivers and therapists. These interviews will be transcribed and thematically analysed.Ethics and dissemination Ethics approval was obtained from the Ethics Committee of Taipei Medical University (approval number: N201804055). The findings will be disseminated through presentations at scientific conferences and through publication in peer-reviewed journals.Trial registration number NCT03792061; pre-results.https://bmjopen.bmj.com/content/10/12/e040241.full
spellingShingle Tsan-Hon Liou
Lu Lu
Feng-Hang Chang
Valeria Chiu
Pengsheng Ni
Yen-Nung Lin
Jiunn-Horng Kang
Der-Sheng Han
Elizabeth R Skidmore
Enhancing community participation for stroke survivors with cognitive impairment: study protocol for a randomised controlled trial in Taiwan
BMJ Open
title Enhancing community participation for stroke survivors with cognitive impairment: study protocol for a randomised controlled trial in Taiwan
title_full Enhancing community participation for stroke survivors with cognitive impairment: study protocol for a randomised controlled trial in Taiwan
title_fullStr Enhancing community participation for stroke survivors with cognitive impairment: study protocol for a randomised controlled trial in Taiwan
title_full_unstemmed Enhancing community participation for stroke survivors with cognitive impairment: study protocol for a randomised controlled trial in Taiwan
title_short Enhancing community participation for stroke survivors with cognitive impairment: study protocol for a randomised controlled trial in Taiwan
title_sort enhancing community participation for stroke survivors with cognitive impairment study protocol for a randomised controlled trial in taiwan
url https://bmjopen.bmj.com/content/10/12/e040241.full
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