StrokeNCT07159256
Impact of Processing Speed on Motor, Balance, Gait, and Quality of Life in Stroke"
An observational study of Stroke and Ischaemic Stroke, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial summary
Stroke rehabilitation programs are traditionally designed based on the evaluation of motor and sensory impairments starting from the acute phase. Although studies in diseases such as multiple sclerosis and Parkinson's disease have shown that information processing speed may affect motor function and balance, no such… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Stroke, Ischaemic Stroke
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2025to 7 Nov 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients aged 40-74 years who experienced a first-ever ischemic stroke and are hemodynamically stable. Eligible participants will be literate, without prior psychiatric, neurological, visual, auditory, or orthopedic conditions affecting mobilization. Patients must have full scores in the vision and speech domains of the NIH Stroke Scale (NIHSS) after stroke. Individuals with recurrent stroke, severe cognitive or language impairments, post-stroke visual or auditory deficits, neglect, cardiovascular or orthopedic conditions preventing mobilization, or those aged 75 years and older will be excluded.
Who may be able to join
- Age 40 years or older
- First-ever ischemic stroke
- Hemodynamically stable
- Able to read and write (literate)
- No history of psychiatric, neurological, visual, auditory, or orthopedic conditions prior to stroke that could affect mobilization
- After stroke, full scores in the vision and speech domains according to the NIH Stroke Scale (NIHSS)
Who cannot join
- Recurrent stroke
- Post-stroke visual or hearing impairment
- Neglect
- Aphasia
- Conditions causing impaired consciousness such as dementia, confusion, or delirium
- Presence of cardiovascular or orthopedic conditions after stroke that prevent mobilization
- Age 75 years or older
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul Aydın University
Istanbul, Küçükçekmece, 34295
About this study
Official title: The Effect of Information Processing Speed on Motor Function, Balance, Gait, and Quality of Life in Patients With Ischemic Stroke
Stroke rehabilitation programs are traditionally designed based on the evaluation of motor and sensory impairments starting from the acute phase. Although studies in diseases such as multiple sclerosis and Parkinson's disease have shown that information processing speed may affect motor function and balance, no such study has been conducted in stroke patients.
This study aims to investigate the effect of information processing speed on motor function, balance, gait, and quality of life in patients with ischemic stroke.
Read the detailed description
A review of the literature reveals that in stroke patients, motor and sensory impairments are evaluated beginning in the acute phase, and rehabilitation programs are structured accordingly. While research has demonstrated that information processing speed can influence motor function and balance in other neurological conditions such as multiple sclerosis and Parkinson's disease, no similar studies exist for stroke populations.
The investigators hypothesize that early evaluation of motor, sensory, and cognitive deficits in patients with ischemic stroke, and incorporating these findings into rehabilitation programs, may positively impact prognosis.
This study will recruit patients admitted for treatment at the Physical Medicine and Rehabilitation Unit of Istanbul Aydın University VM Medical Park Florya Hospital. Inclusion criteria are: age ≥ 40 years, first-ever ischemic stroke, hemodynamic stability, literacy, and absence of pre-stroke psychiatric, neurological, visual, auditory, or orthopedic conditions that may affect mobilization. Additionally, patients must score full points in the vision and speech domains of the NIHSS after stroke.
Eligible participants' demographic and clinical data will be recorded. Information processing speed will be assessed using the Symbol Digit Modalities Test (SDMT). Motor function will be evaluated with the Fugl-Meyer Assessment (FMA), balance with the Berg Balance Scale (BBS) and the Sense4Motion Euleria Health device, gait with the Timed Up and Go Test (TUG), and quality of life with the Stroke-Specific Quality of Life Scale (SS-QOL).
- Conditions
- Stroke, Ischaemic Stroke
- Keywords
- Information Processing Speed, Motor Function, Balance, Gait, Quality of Life, ischaemic stroke
- Medical subject headings
- Stroke, Ischemic Stroke
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 |
|---|---|---|
| Single Group Assignment | All participants will be patients diagnosed with first-ever ischemic stroke, aged 40 years or older, hemodynamically stable, literate, and without pre-stroke psychiatric, neurological, visual, auditory, or orthopedic conditions that could affect mobilization. Participants will undergo a series of standardized assessments including information processing speed (Symbol Digit Modalities Test), motor function (Fugl-Meyer Assessment), balance (Berg Balance Scale and Sense4Motion Euleria Health device), gait (Timed Up and Go Test), and quality of life (Stroke-Specific Quality of Life Scale). The aim is to evaluate the relationship between processing speed and functional outcomes in ischemic stroke rehabilitation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symbol Digit Modalities Test (SDMT) Score
The Symbol Digit Modalities Test (SDMT) will be used to assess information processing speed. The test requires participants to match symbols with corresponding numbers according to a reference key within 90 seconds. The total number of correct responses will be recorded, with higher scores indicating better processing speed.
Measured: At baseline (single assessment)
Secondary outcomes (5)
Berg Balance Scale (BBS) Score
The Berg Balance Scale (BBS) will be used to evaluate functional balance. The test consists of 14 tasks, including sitting, standing, reaching, and turning activities, each scored on a 5-point scale from 0 (unable to perform) to 4 (independent performance). The total score ranges from 0 to 56, with higher scores indicating better balance.
Measured: At baseline (single assessment)
Fugl-Meyer Assessment (FMA) Score
The Fugl-Meyer Assessment (FMA) will be used to evaluate motor function in stroke patients. The scale assesses movement, coordination, and reflexes of the upper and lower extremities. Scores range from 0 to 100, with higher scores indicating better motor function and recovery.
Measured: At baseline (single assessment)
Stroke-Specific Quality of Life Scale (SS-QOL) Score
The Stroke-Specific Quality of Life Scale (SS-QOL) will be used to assess health-related quality of life. It consists of 49 items across 12 domains (e.g., mobility, mood, energy, self-care, social roles). Each item is scored on a 5-point Likert scale, with higher scores indicating better quality of life.
Measured: At baseline (single assessment)
Balance Assessment with Sense4Motion Euleria Health / Euleria Lab Device
The Sense4Motion Euleria Health (Euleria Lab) device will be used for objective balance assessment. This wearable inertial sensor system measures postural stability and body sway during standardized balance tasks. Quantitative parameters such as sway velocity, sway area, and stability index will be recorded. Lower sway values and higher stability indices indicate better balance performance.
Measured: At baseline (single assessment)
Timed Up and Go Test (TUG) with Euleria Health / Euleria Lab
The gait module of Euleria Health (Euleria Lab) device will be used to perform the Timed Up and Go (TUG) test. Participants will be asked to rise from a chair, walk three meters, turn, return, and sit down. The device's inertial sensors will record spatiotemporal gait parameters such as duration (seconds), number of steps, gait speed, and turning characteristics. Lower times and more stable gait parameters indicate better functional mobility.
Measured: At baseline (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start5 Sep 2025
- Primary completion7 Oct 2025 (estimated)
- Study completion7 Nov 2025 (estimated)
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 only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dudu Kübra AKYOL, Istanbul Aydın University
- Investigators
- Gökhan ÖZKOÇAK, MD, Study chair, Istanbul Aydın UniversityÖzden Erkan Oğul, Asst. Prof, Study chair, Medipol Universityİbrahim H Ural, MD, Study chair, Beykent UniversityArzu DİNÇ YAVAŞ, MD, Study chair, Istanbul Aydın UniversityDudu K AKYOL, PT, Principal investigator, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159256
- Sponsor's protocol ID
- IstanbulIAU
- Status last verified
- Sep 2025
- First submitted
- 29 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Information Processing Speed on Motor Function, Balance, Gait, and Quality of Life in Patients With Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07159256
- Acronym / sponsor ID
- IstanbulIAU
- Conditions
- Stroke, Ischaemic Stroke
- Keywords
- Information Processing Speed, Motor Function, Balance, Gait, Quality of Life, ischaemic stroke
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Study start
- 5 Sep 2025 (actual)
- Primary completion
- 7 Oct 2025 (estimated)
- Study completion
- 7 Nov 2025 (estimated)
- First posted
- 8 Sep 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.
Stroke rehabilitation programs are traditionally designed based on the evaluation of motor and sensory impairments starting from the acute phase. Although studies in diseases such as multiple sclerosis and Parkinson's disease have shown that information processing speed may affect motor function and balance, no such study has been conducted in stroke patients.
This study aims to investigate the effect of information processing speed on motor function, balance, gait, and quality of life in patients with ischemic stroke.
Detailed description
A review of the literature reveals that in stroke patients, motor and sensory impairments are evaluated beginning in the acute phase, and rehabilitation programs are structured accordingly. While research has demonstrated that information processing speed can influence motor function and balance in other neurological conditions such as multiple sclerosis and Parkinson's disease, no similar studies exist for stroke populations.
The investigators hypothesize that early evaluation of motor, sensory, and cognitive deficits in patients with ischemic stroke, and incorporating these findings into rehabilitation programs, may positively impact prognosis.
This study will recruit patients admitted for treatment at the Physical Medicine and Rehabilitation Unit of Istanbul Aydın University VM Medical Park Florya Hospital. Inclusion criteria are: age ≥ 40 years, first-ever ischemic stroke, hemodynamic stability, literacy, and absence of pre-stroke psychiatric, neurological, visual, auditory, or orthopedic conditions that may affect mobilization. Additionally, patients must score full points in the vision and speech domains of the NIHSS after stroke.
Eligible participants' demographic and clinical data will be recorded. Information processing speed will be assessed using the Symbol Digit Modalities Test (SDMT). Motor function will be evaluated with the Fugl-Meyer Assessment (FMA), balance with the Berg Balance Scale (BBS) and the Sense4Motion Euleria Health device, gait with the Timed Up and Go Test (TUG), and quality of life with the Stroke-Specific Quality of Life Scale (SS-QOL).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group Assignment | – | –All participants will be patients diagnosed with first-ever ischemic stroke, aged 40 years or older, hemodynamically stable, literate, and without pre-stroke psychiatric, neurological, visual, auditory, or orthopedic conditions that could affect mobilization. Participants will undergo a series of standardized assessments including information processing speed (Symbol Digit Modalities Test), motor function (Fugl-Meyer Assessment), balance (Berg Balance Scale and Sense4Motion Euleria Health device), gait (Timed Up and Go Test), and quality of life (Stroke-Specific Quality of Life Scale). The aim is to evaluate the relationship between processing speed and functional outcomes in ischemic stroke rehabilitation. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients aged 40-74 years who experienced a first-ever ischemic stroke and are hemodynamically stable. Eligible participants will be literate, without prior psychiatric, neurological, visual, auditory, or orthopedic conditions affecting mobilization. Patients must have full scores in the vision and speech domains of the NIH Stroke Scale (NIHSS) after stroke. Individuals with recurrent stroke, severe cognitive or language impairments, post-stroke visual or auditory deficits, neglect, cardiovascular or orthopedic conditions preventing mobilization, or those aged 75 years and older will be excluded.
Key inclusion criteria (6 listed)
- Age 40 years or older
- First-ever ischemic stroke
- Hemodynamically stable
- Able to read and write (literate)
- No history of psychiatric, neurological, visual, auditory, or orthopedic conditions prior to stroke that could affect mobilization
Key exclusion criteria (7 listed)
- Recurrent stroke
- Post-stroke visual or hearing impairment
- Neglect
- Aphasia
- Conditions causing impaired consciousness such as dementia, confusion, or delirium
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
Symbol Digit Modalities Test (SDMT) Score
Time frame: At baseline (single assessment)
The Symbol Digit Modalities Test (SDMT) will be used to assess information processing speed. The test requires participants to match symbols with corresponding numbers according to a reference key within 90 seconds. The total number of correct responses will be recorded, with higher scores indicating better processing speed.
5 secondary outcomes
Berg Balance Scale (BBS) Score
Time frame: At baseline (single assessment)
Fugl-Meyer Assessment (FMA) Score
Time frame: At baseline (single assessment)
Stroke-Specific Quality of Life Scale (SS-QOL) Score
Time frame: At baseline (single assessment)
Balance Assessment with Sense4Motion Euleria Health / Euleria Lab Device
Time frame: At baseline (single assessment)
Timed Up and Go Test (TUG) with Euleria Health / Euleria Lab
Time frame: At baseline (single assessment)
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 11 Sep 2025.
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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.
Gökhan ÖZKOÇAK, MD study chair
Istanbul Aydın University
Özden Erkan Oğul, Asst. Prof study chair
Medipol University
İbrahim H Ural, MD study chair
Beykent University
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 and Ischaemic Stroke, run by Istanbul Aydın 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 7 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: enrolling by invitation, as of the sponsor's last update on 11 Sep 2025. 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?
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?
Symbol Digit Modalities Test (SDMT) Score (time frame: At baseline (single assessment)). 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 11 Sep 2025.