Five-year Changes in Patients With Chronic Stroke

Chronic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06191406
• Other study ID #: HE661406
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: January 2024
• Source: Khon Kaen University
• Contact: Yanisa Sinthunyathum, MD
• Phone: +66861735660
• Email: yanisa34854[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Chronic Stroke
• Stroke

Intervention

Diagnostic Test:
• 6 minute walk test
Test for physical functions and cognitive functions

Locations

Country	Name	City	State
Thailand	Srinagarind Hospital Khon Kaen University	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-minute walk test	walk distance covered over a time of 6 minutes	5 years
Primary	10-meter walk test	comfortable & fast gait speed	5 years
Primary	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	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
Secondary	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
Secondary	Fatigue assessment scale	Fatigue assessment scale questionnaire Minimum score = 10 (better outcome, less fatigue) Maximum score = 50 (worst outcome, more fatigue)	5 years
Secondary	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