Chronic Stroke PatientsNCT07078903
Cognitive Impairment and Gait Balance in Chronic Stroke Survivors
An observational study of Chronic Stroke Patients, run by Islam Hassan Fayed.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Chronic Stroke Patients
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Stroke Patients
- Keywords
- Cognitive Impairment, Chronic Stroke, Gait Balance
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Correlation between IQCODE scores and center of pressure velocity (eyes open)
Assess the relationship between cognitive impairment and balance control by comparing IQCODE scores with center of pressure velocity during quiet standing with eyes open.
Measured: At baseline (single session)
Secondary outcomes (1)
Correlation between IQCODE scores and center of pressure velocity (eyes closed)
Assess the relationship between cognitive impairment and postural control by comparing IQCODE scores with center of pressure velocity during quiet standing with eyes closed.
Measured: At baseline (single session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stroke PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Islam Hassan Fayed
- Sponsor type
- University, hospital or other
- Collaborators
- Majmaah University
- Responsible party
- Sponsor-investigator, Islam Hassan Fayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078903
- Sponsor's protocol ID
- MUREC-March.17/COM-2021/30-3
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Cognitive Impairment and Gait Balance in Chronic Stroke Survivors: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07078903
- Acronym / sponsor ID
- MUREC-March.17/COM-2021/30-3
- Conditions
- Chronic Stroke Patients
- Keywords
- Cognitive Impairment, Chronic Stroke, Gait Balance
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Islam Hassan FayedUniversity, hospital or other
- Collaborators
- Majmaah University
- Study start
- Aug 2025 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Correlation between IQCODE scores and center of pressure velocity (eyes closed)
Time frame: At baseline (single session)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Stroke Patients, run by Islam Hassan Fayed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between IQCODE scores and center of pressure velocity (eyes open) (time frame: At baseline (single session)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.