NCT06191406

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 9, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

8 months

First QC Date

December 9, 2023

Last Update Submit

October 7, 2024

Conditions

Chronic Stroke

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Global quality of life

    5 years

  • Short FES-I

    5 years

  • Fatigue assessment scale

    5 years

  • Barthel index

    5 years

Interventions

6 minute walk testDIAGNOSTIC_TEST

Test for physical functions and cognitive functions

Also known as: 10 meters walk test, Thai MMSE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Srinagarind Hospital Khon Kaen University

Khon Kaen, 40001, Thailand

Location

MeSH Terms

Interventions

Walk Test

Intervention Hierarchy (Ancestors)

Exercise TestHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident in Physical medicine and rehabilitation department, Principal Investigator

Study Record Dates

First Submitted

December 9, 2023

First Posted

January 5, 2024

Study Start

November 1, 2023

Primary Completion

July 1, 2024

Study Completion

September 1, 2024

Last Updated

October 8, 2024

Record last verified: 2024-10

Locations

TH(1)