NCT03792061

Enhancing Community Participation for Stroke Survivors With Cognitive Impairments

Active, enrolled NA Last updated 20 November 2024

What this trial tests

NA trial testing Strategy Training in Stroke in 210 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

13 January 2019

Primary endpoint
22 August 2024

31 December 2024

Quick facts

Lead sponsor	Taipei Medical University
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	210
Start date	13 January 2019
Primary completion	22 August 2024
Estimated completion	31 December 2024
Sites	4 locations across Taiwan

Drugs / interventions tested

• Strategy Training

Conditions studied

• Stroke — all drugs for Stroke →
• Cognitive Impairment — all drugs for Cognitive Impairment →

Sponsor

Taipei Medical University

Who can join

20 and older, any sex, with Stroke or Cognitive Impairment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Abstract

Method: Participants with a diagnosis of stroke and have cognitive impairment (a score of 3 or more on the Executive Interview, 14-item version) will be randomly assigned to the intervention group and the attention control group at a 1:1 ratio. Each session will be around 45 minutes and will be delivered 1 to 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), Stroop Test, Montreal Cognitive Assessment (MoCA), Trail-Making Test (TMT A and B), The National Institutes of Health Stroke scale (NIHSS), modified Rankin Scale (MRS), Euro-QoL-5-Dimension (EQ-5D) 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).

Of the recruited participants, 50 will recieve the fMRI tests (including the resting-state scan, the fMRI scan with Stroop Test and TMT tasks, and the anatomical structure scan) at baseline, post-intervention, and 6month follow-up.Data will be analyzed using multiple linear regression models and mixed-effects regression models.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Occupational therapy for cognitive impairment in stroke patients.
   Gibson E, Koh CL, Eames S, Bennett S, et al · · 2022 · cited 29× · PMID 35349186 · DOI 10.1002/14651858.cd006430.pub3
2. Enhancing community participation for stroke survivors with cognitive impairment: study protocol for a randomised controlled trial in Taiwan.
   Chang FH, Chiu V, Ni P, Lin YN, et al · · 2020 · cited 8× · PMID 33293312 · DOI 10.1136/bmjopen-2020-040241
3. Effect of participation-focused strategy training on post-stroke cognitive functions and quality of life: results from a randomized trial.
   Hsu SP, Skidmore ER, Kang JH, Chiu V, et al · · 2026 · PMID 42013638 · DOI 10.1016/j.rehab.2026.102116
4. Enhancing Societal Participation for Stroke Survivors With Cognitive Impairments: A Randomized Controlled Trial.
   Hsu SP, Hung TH, Lin YN, Kang JH, et al · · 2025 · PMID 40970531 · DOI 10.1161/jaha.125.042295