StrokeNCT07887776
Physical Performance and Cognitive Functions in Patients With Chronic Stroke
An observational study of Stroke, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the impact of cognitive impairment on upper extremity physical performance, cognitive skills, and functional independence in individuals with chronic stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 1 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprises adult patients of both genders, aged between 18 and 80 years, who have experienced a single ischemic or hemorrhagic stroke at least six months prior to enrollment (chronic stroke phase). Participants are recruited from outpatient physical therapy and rehabilitation clinics. Based on their cognitive screening using the Montreal Cognitive Assessment (MoCA), the study population is categorized into two comparative cohorts: a Cognitive Impairment Group and a Control Group. Eligible participants must be able to communicate effectively, be literate, and have no pre-existing cognitive disorders, severe medical comorbidities, or concurrent neurological/orthopedic conditions that could independently affect physical or cognitive performance.
Who may be able to join
- History of ischemic or hemorrhagic stroke diagnosed at least 6 months prior to the study,
- First-ever stroke
- Absence of communication or language disorders that would prevent understanding and cooperation
- Ability to read and write
- Not currently receiving psychotropic medication treatment
- Willingness to participate and provision of signed informed consent
Who cannot join
- Having a chronic and severe medical condition (e.g., epilepsy, cerebral palsy)
- Presence of any other concurrent orthopedic or neurological disease affecting physical or cognitive performance
- History of recent surgery
- History of any pre-existing condition affecting cognitive status (e.g., dementia, neurodegenerative diseases)
- Complete loss of vision or hearing
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Doç. Dr. Mustafa Kalemli Tavsanli State Hospital
Kütahya, Tavşanlı, 43300
About this study
Official title: The Effect of Cognitive Impairment on Upper Extremity Physical Performance and Cognitive Functions in Patients With Chronic Stroke
This study aims to investigate the impact of cognitive impairment on upper extremity physical performance, cognitive skills, and functional independence in individuals with chronic stroke. A total of 66 chronic stroke survivors will be enrolled and categorized into two groups based on their Montreal Cognitive Assessment (MoCA) scores: the Cognitive Impairment Group (n=33) and the Control Group (n=33). Upper extremity performance, cognitive functions, and functional independence will be comprehensively evaluated using standardized clinical outcome measures.
Read the detailed description
Background and Rationale:
Cognitive impairment is a frequent and disabling consequence of stroke that can significantly hinder motor recovery, physical performance, and independence in activities of daily living. Although physical rehabilitation predominantly focuses on motor functions, the intricate relationship between cognitive status and upper extremity performance warrants deeper investigation.
Objective:
To examine the effects of cognitive impairment on upper extremity physical performance, specific cognitive domains (attention and working memory), and functional independence in individuals with chronic stroke.
Study Design and Participants:
This cross-sectional comparative study will include 66 volunteer participants with chronic stroke. Participants will be divided into two equal groups (n=33 each) based on a cutoff threshold of the Montreal Cognitive Assessment (MoCA): a Cognitive Impairment Group and a Control Group. Both groups will be matched for age, stroke duration, sex, education level, and affected stroke side.
Assessments \& Outcome Measures:
Upper Extremity Physical Performance: Evaluated using the Wolf Motor Function Test (WMFT), Fugl-Meyer Upper Extremity Assessment (FM-UE), and the Box and Block Test (BBT).
Cognitive Skills: Evaluated using the Stroop Test, Forward Digit Span Test, and Backward Digit Span Test to assess executive functions, attention, and working memory.
Functional Independence: Evaluated using the Functional Independence Measure (FIM), separating motor and cognitive sub-scores.
Significance:
The findings of this study are expected to highlight the critical interaction between cognitive status and upper extremity motor performance in chronic stroke. Consequently, the results will emphasize the necessity of integrating routine cognitive assessments into standard clinical protocols and tailoring stroke rehabilitation programs to address patients' cognitive profiles.
- Conditions
- Stroke
- Keywords
- Cronic stroke, cognitive impairment, upper extremity, motor performance, functional independence
- Medical subject headings
- Stroke, 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 |
|---|---|---|
| Cognitive Impairment Group | Scoring 20 or lower on the Montreal Cognitive Assessment (MoCA) | |
| Control Group | Scoring 21 or higher on the Montreal Cognitive Assessment (MoCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Function Test (WMFT) Performance Time
valuates upper extremity motor ability and functional performance through timed and functional tasks. WMFT performance time is measured in seconds, where longer durations indicate lower performance.
Measured: Baseline (Single assessment session)
Fugl-Meyer Upper Extremity Assessment (FM-UE) Score
Measures motor recovery, reflex activity, and movement coordination in the upper extremity. Scores range from 0 to 66, with higher scores indicating better motor function.
Measured: Baseline (Single assessment session)
Box and Block Test (BBT) Score
Assesses unilateral manual dexterity. It measures the number of blocks transported from one compartment to another within 60 seconds (evaluated separately for affected and unaffected upper extremities).
Measured: Baseline (Single assessment session)
Functional Independence Measure (FIM) Motor and Cognitive Sub-scores
Evaluates the level of independence in activities of daily living. It consists of motor and cognitive sub-scales, where higher scores reflect greater functional independence.
Measured: Baseline (Single assessment session)
Secondary outcomes (2)
Stroop Test Completion Times
Measures cognitive flexibility, selective attention, and executive functions. Completion times are recorded in seconds, where longer durations indicate greater cognitive impairment.
Measured: Baseline (Single assessment session)
Forward and Backward Digit Span Test Scores
Evaluates attention, short-term memory, and working memory capacity. Scores are based on the maximum number of digits successfully repeated in forward and backward order
Measured: Baseline (Single assessment session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Jan 2025
- Primary completion30 Jun 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Okur, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887776
- Sponsor's protocol ID
- KSBU 2024/11-08
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cognitive Impairment on Upper Extremity Physical Performance and Cognitive Functions in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT07887776
- Acronym / sponsor ID
- KSBU 2024/11-08
- Conditions
- Stroke
- Keywords
- Cronic stroke, cognitive impairment, upper extremity, motor performance, functional independence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 21 Oct 2026 (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 impact of cognitive impairment on upper extremity physical performance, cognitive skills, and functional independence in individuals with chronic stroke. A total of 66 chronic stroke survivors will be enrolled and categorized into two groups based on their Montreal Cognitive Assessment (MoCA) scores: the Cognitive Impairment Group (n=33) and the Control Group (n=33). Upper extremity performance, cognitive functions, and functional independence will be comprehensively evaluated using standardized clinical outcome measures.
Detailed description
Background and Rationale:
Cognitive impairment is a frequent and disabling consequence of stroke that can significantly hinder motor recovery, physical performance, and independence in activities of daily living. Although physical rehabilitation predominantly focuses on motor functions, the intricate relationship between cognitive status and upper extremity performance warrants deeper investigation.
Objective:
To examine the effects of cognitive impairment on upper extremity physical performance, specific cognitive domains (attention and working memory), and functional independence in individuals with chronic stroke.
Study Design and Participants:
This cross-sectional comparative study will include 66 volunteer participants with chronic stroke. Participants will be divided into two equal groups (n=33 each) based on a cutoff threshold of the Montreal Cognitive Assessment (MoCA): a Cognitive Impairment Group and a Control Group. Both groups will be matched for age, stroke duration, sex, education level, and affected stroke side.
Assessments \& Outcome Measures:
Upper Extremity Physical Performance: Evaluated using the Wolf Motor Function Test (WMFT), Fugl-Meyer Upper Extremity Assessment (FM-UE), and the Box and Block Test (BBT).
Cognitive Skills: Evaluated using the Stroop Test, Forward Digit Span Test, and Backward Digit Span Test to assess executive functions, attention, and working memory.
Functional Independence: Evaluated using the Functional Independence Measure (FIM), separating motor and cognitive sub-scores.
Significance:
The findings of this study are expected to highlight the critical interaction between cognitive status and upper extremity motor performance in chronic stroke. Consequently, the results will emphasize the necessity of integrating routine cognitive assessments into standard clinical protocols and tailoring stroke rehabilitation programs to address patients' cognitive profiles.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Impairment Group | – | –Scoring 20 or lower on the Montreal Cognitive Assessment (MoCA) |
| Control Group | – | –Scoring 21 or higher on the Montreal Cognitive Assessment (MoCA) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises adult patients of both genders, aged between 18 and 80 years, who have experienced a single ischemic or hemorrhagic stroke at least six months prior to enrollment (chronic stroke phase). Participants are recruited from outpatient physical therapy and rehabilitation clinics. Based on their cognitive screening using the Montreal Cognitive Assessment (MoCA), the study population is categorized into two comparative cohorts: a Cognitive Impairment Group and a Control Group. Eligible participants must be able to communicate effectively, be literate, and have no pre-existing cognitive disorders, severe medical comorbidities, or concurrent neurological/orthopedic conditions that could independently affect physical or cognitive performance.
Key inclusion criteria (6 listed)
- History of ischemic or hemorrhagic stroke diagnosed at least 6 months prior to the study,
- First-ever stroke
- Absence of communication or language disorders that would prevent understanding and cooperation
- Ability to read and write
- Not currently receiving psychotropic medication treatment
Key exclusion criteria (5 listed)
- Having a chronic and severe medical condition (e.g., epilepsy, cerebral palsy)
- Presence of any other concurrent orthopedic or neurological disease affecting physical or cognitive performance
- History of recent surgery
- History of any pre-existing condition affecting cognitive status (e.g., dementia, neurodegenerative diseases)
- Complete loss of vision or hearing
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
Wolf Motor Function Test (WMFT) Performance Time
Time frame: Baseline (Single assessment session)
valuates upper extremity motor ability and functional performance through timed and functional tasks. WMFT performance time is measured in seconds, where longer durations indicate lower performance.
Fugl-Meyer Upper Extremity Assessment (FM-UE) Score
Time frame: Baseline (Single assessment session)
Measures motor recovery, reflex activity, and movement coordination in the upper extremity. Scores range from 0 to 66, with higher scores indicating better motor function.
Box and Block Test (BBT) Score
Time frame: Baseline (Single assessment session)
Assesses unilateral manual dexterity. It measures the number of blocks transported from one compartment to another within 60 seconds (evaluated separately for affected and unaffected upper extremities).
Functional Independence Measure (FIM) Motor and Cognitive Sub-scores
Time frame: Baseline (Single assessment session)
Evaluates the level of independence in activities of daily living. It consists of motor and cognitive sub-scales, where higher scores reflect greater functional independence.
2 secondary outcomes
Stroop Test Completion Times
Time frame: Baseline (Single assessment session)
Forward and Backward Digit Span Test Scores
Time frame: Baseline (Single assessment session)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 6 inclusion and 5 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: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Wolf Motor Function Test (WMFT) Performance Time (time frame: Baseline (Single assessment session)). The study lists 4 primary outcomes in all. 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 21 Oct 2026.