Five-year Changes in Patients With Chronic Stroke

Five-year Changes in Physical and Cognitive Function in Patients With Chronic Stroke: a Preliminary Retrospective Cohort Study

Objective of the study:

• To determine changes in physical and cognitive function in patients with chronic stroke over 5 years
• To determine whether there are differences in physical and cognitive function in chronic stroke patients with different baseline levels of physical activity

Study Overview

• Status: Completed
• Conditions: Chronic Stroke
• Intervention / Treatment: Diagnostic test: 6 minute walk test

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Thailand
  • Khon Kaen, Thailand, 40001
    • Srinagarind Hospital Khon Kaen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Stroke patients whose physical activity was assessed in 2018 - 2019 (Previous research study: Validity and Test-Retest Reliability of a Thai Stroke Physical Activity Questionnaire) which the population was stroke patients, aged ≥ 18 years with onset > 3 months. The study population is composed of patients who have achieved a compliance rate of more than 70% with the accelerometer within 1 week, total 50 people.

Description

Inclusion Criteria:

- Stroke patients whose physical activity was assessed in 2018 - 2019 (Previous research study)

Exclusion Criteria:

- None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-minute walk test	walk distance covered over a time of 6 minutes	5 years
10-meter walk test	comfortable & fast gait speed	5 years
Thai MMSE	test patient's cognition with mini-mental state examination (MMSE) Minimum score = 0 (worst outcome, poor cognitive function) Maximum score = 30 (better outcome, good cognitive function)	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global quality of life	Global quality of life questionnaire which the patient will give their own score of their quality of life, scale from 0-100 (0 = worst quality of life, 100 = best quality of life)	5 years
Short FES-I	the Short Falls Efficacy Scale International (Short FES-I) questionnaire Minimum score = 7 (better outcome, less fear of falling) Maximum score = 28 (worst outcome, most fear of falling)	5 years
Fatigue assessment scale	Fatigue assessment scale questionnaire Minimum score = 10 (better outcome, less fatigue) Maximum score = 50 (worst outcome, more fatigue)	5 years
Barthel index	Barthel index questionnaire Minimum score = 0 (worst outcome, mostly dependent in daily living) Maximum score = 100 (better outcome, independent in daily living)	5 years

Collaborators and Investigators

• Sponsor: Khon Kaen University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: December 9, 2023
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: HE661406

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No