- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07078903
- Original Trial
Cognitive Impairment and Gait Balance in Chronic Stroke Survivors
July 14, 2025 updated by: Islam Hassan Fayed
Relationship Between Cognitive Impairment and Gait Balance in Chronic Stroke Survivors: A Cross-Sectional Study
This study aims to investigate the relationship between cognitive impairment and gait balance in individuals with chronic stroke.
Using the IQCODE and a balance assessment system, the study evaluates how post-stroke cognitive decline may influence stability and motor control.
The findings will support better rehabilitation strategies tailored to cognitive function.
Study Overview
Status
Not yet recruiting
Conditions
Detailed Description
Cognitive and motor impairments are common consequences of stroke, but they are often treated separately.
A growing body of evidence suggests a potential link between cognitive function and physical performance, including balance and gait.
This prospective, cross-sectional study investigates the relationship between post-stroke cognitive impairment and gait balance in chronic stroke survivors.
Participants will undergo cognitive evaluation using the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE), and gait balance will be assessed through center of pressure velocity with eyes open and closed.
The goal is to identify whether cognitive decline is associated with impaired balance performance and to explore the influence of age, stroke type, and duration on these outcomes.
Study Type
Observational
Enrollment (Estimated)
26
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
A non-random sample of 26 adults aged 25-75 years with chronic stroke, recruited from outpatient rehabilitation centers.
Participants were assessed in a single session to evaluate the relationship between cognitive impairment and gait balance.
Description
Inclusion Criteria:
- Adults aged 25-75 years
- Diagnosed with chronic stroke (≥6 months post-stroke)
- Able to stand independently for testing
- Capable of completing assessments or has an informant available for IQCODE
Exclusion Criteria:
- Severe visual, vestibular, or musculoskeletal impairments
- History of other neurological disorders
- Acute illness or uncontrolled medical condition
- Inability to follow instructions or complete cognitive/balance assessments
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Chronic Stroke Survivors
A group of 26 adults with chronic stroke will be assessed to examine the relationship between cognitive impairment and gait balance.
Cognitive function will be evaluated using the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE), and balance will be assessed using center of pressure measurements with eyes open and closed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between IQCODE scores and center of pressure velocity (eyes open)
Time Frame: At baseline (single session)
|
Assess the relationship between cognitive impairment and balance control by comparing IQCODE scores with center of pressure velocity during quiet standing with eyes open.
|
At baseline (single session)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation between IQCODE scores and center of pressure velocity (eyes closed)
Time Frame: At baseline (single session)
|
Assess the relationship between cognitive impairment and postural control by comparing IQCODE scores with center of pressure velocity during quiet standing with eyes closed.
|
At baseline (single session)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2025
Primary Completion (Estimated)
September 1, 2025
Study Completion (Estimated)
September 1, 2025
Study Registration Dates
First Submitted
July 14, 2025
First Submitted That Met QC Criteria
July 14, 2025
First Posted (Actual)
July 22, 2025
Study Record Updates
Last Update Posted (Actual)
July 22, 2025
Last Update Submitted That Met QC Criteria
July 14, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUREC-March.17/COM-2021/30-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Your dataset is small, with identifiable clinical information, which raises privacy and ethical concerns.
There's no formal plan in place for anonymized data sharing.
Most ICMJE-compliant journals accept a "No" or "Undecided" answer, especially for observational studies that do not involve public databases.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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