Functional IndependenceNCT05665673
Relation of Functional ındependence to Balance, Exercise Capacity, and Peripheral Muscle Strength
An observational study of Functional Independence and Balance; Distorted, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
Stroke is one of the leading causes of death worldwide and is among the most important diseases that cause long-term disability in adults. In high-income countries, the incidence of stroke has decreased significantly with increased use of preventive therapies and control of risk factors. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Functional Independence, Balance; Distorted, Exercise Capacity
- What is being tested?
- Physical functions test
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Dec 2022to 1 Jul 2023
- How long will I take part?
- 1 Day
- 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 40 to 85 years
- All sexes
- Adult, Older adult
Study population: Individuals with chronic stroke
Who may be able to join
- Having had a stroke for the first time at least 6 months ago
- Being 40 years or older
- Having a Mini-Mental Test result of more than 24 points
- The lower extremity score for Brunnstrom is 5-7
- Being 3 and above according to the functional ambulation scale
- Willingness and willingness to work
- Being able to speak and understand Turkish
Who cannot join
- Having a different neurological, orthopedic, and rheumatological disease
- Having a visual or hearing impairment
- Having uncontrollable cardiopulmonary and unstable chronic diseases
- Having had a transient ischemic attack or multiple strokes
- Lack of independent sitting and standing balance
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yunus Emre TÜTÜNEKEN
Istanbul, Zeytinburnu, 34010
About this study
Official title: Relation of Functional ındependence to Balance, Exercise Capacity, and Peripheral Muscle Strength in Individuals With Chronic Stroke
Stroke is one of the leading causes of death worldwide and is among the most important diseases that cause long-term disability in adults. In high-income countries, the incidence of stroke has decreased significantly with increased use of preventive therapies and control of risk factors. Stroke has a significant impact on individuals' independence and productivity.
Walking capacity is limited due to motor control, balance, and muscle strength disorders after stroke. In addition, it was determined that the functional exercise capacity of stroke patients decreased when compared to healthy individuals of the same age. The quantitative decrease in muscle mass due to physical inactivity is accompanied by sarcopenia, which worsens the situation. Although the primary impairments affecting gait are muscle strength weakness and loss of coordination, impaired cardiorespiratory fitness can also affect walking performance by limiting endurance. Depending on the change in each parameter after stroke, the functional independence and daily living activities of individuals are affected.
A correlation was found between balance and functional mobility and the level of functional independence in stroke patients. It has been found that having a good balance function after stroke significantly increases the likelihood of being functionally independent. When the studies in the literature were examined, no study was found that directly showed the relationship between functional exercise capacity and muscle strength in stroke patients. Therefore, in our study, we aimed to investigate the relationship between balance, functional exercise capacity, peripheral muscle strength, and functional independence level in stroke patients.
- Conditions
- Functional Independence, Balance; Distorted, Exercise Capacity, Peripheral Muscle Strength
- Being tested
- Physical functions test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical functions testOther
Participants; sociodemographic and descriptive data will be recorded. The Standardized Mini-Mental Test will be used for the global cognitive assessment of participants, the Brunnstrom staging to assess lower extremity motor recovery and indicate at what motor level, and the Functional Ambulation Classification to classify them according to the basic motor skills required for functional ambulation. Gait and balance assessment will be evaluated with Tinetti Balance and Gait Assessment (POMA), functional exercise capacity will be evaluated with 6 Minute Walking Test (6MWT), and peripheral muscle strength will be evaluated with knee extension strength.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Sociodemographic information about the stroke patients included in the study will be obtained and some physical tests will be performed. Receives: Other: Physical functions test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tinetti balance and walking test
TBGT evaluates balance ability and gait under 2 main headings: the first 9 questions are about balance and the next 7 questions are about walking. Calculation of the survey score; The total score of the first 9 items gives the balance score, the total score of the next 7 items gives the walking score, and the sum of the balance and walking scores gives the total score. Item 16 is the whole of the actions done during ADL. As a result of the evaluation made by observation, the scoring is as follows: 2 points; correct execution of the indicated movement, 1 point; performing the specified movement with adaptations, 0 points; failure to move. If the total scale score is 18 and below, it indicates a high risk of falling, a score of 19-24 indicates a moderate fall risk, and a score of 24 and above indicates a low risk of falling.
Measured: 1 day
Timed up and go test (TUG)
TUG is a measurement that can be applied for different purposes in different age and patient groups, evaluating functional mobility, dynamic balance, fall risk, and postural stability. The activities that make up the test evaluate the transition from sitting to standing position, walking, turning, and sitting again, which are necessary for functional mobility and dynamic balance. The ZQM test measures the time it takes for an individual to get up from a standard chair with armrests and walk a distance of 3 meters, return from a designated or marked place, return to the chair, and sit back down. Widely used in clinical practice, this test is used to evaluate functional mobility, fall risk, or dynamic balance as an outcome measure and to establish normative values in the population.
Measured: 1 day
Measuring peripheral muscle strength
Knee extensor strength as peripheral muscle strength will be measured with a portable manual muscle strength measuring device..
Measured: 1 day
6-Minute Walk Test
The individual is asked to walk on a certain track for a period of 6 minutes. The test is performed in a closed area, on a flat surface of 30 m in length, and under the supervision of the evaluator. After six minutes, the total distance walked is recorded in meters.
Measured: 1 day
Functional independence scale (FIM)
This scale, which is used to evaluate the level of physical activity, is an 18-item scale that evaluates 4 physical and 2 cognitive domains and consists of 6 subsections. Each item is scored between 1-7 (1: Fully assisted, 7: Completely independent), and the total score varies between 18-126 (fully dependent-fully independent).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start19 Dec 2022
- Primary completion1 Feb 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional IndependenceStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunus Emre Tutuneken, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665673
- Sponsor's protocol ID
- 5
- Status last verified
- Apr 2025
- First submitted
- 19 Dec 2022
- Last updated
- 15 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tutuneken YE, Yeldan I. Relation of functional independence to balance, exercise capacity, and peripheral muscle strength in individuals with chronic stroke: A cross-sectional study. J Bodyw Mov Ther. 2024 Oct;40:1514-1519. doi: 10.1016/j.jbmt.2024.08.002. Epub 2024 Aug 6.
PubMed 39593480
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relation of Functional ındependence to Balance, Exercise Capacity, and Peripheral Muscle Strength in Individuals With Chronic Stroke
- ClinicalTrials.gov ID
- NCT05665673
- Acronym / sponsor ID
- 5
- Conditions
- Functional Independence, Balance; Distorted, Exercise Capacity, Peripheral Muscle Strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 19 Dec 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 27 Dec 2022 (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 is one of the leading causes of death worldwide and is among the most important diseases that cause long-term disability in adults. In high-income countries, the incidence of stroke has decreased significantly with increased use of preventive therapies and control of risk factors. Stroke has a significant impact on individuals' independence and productivity.
Walking capacity is limited due to motor control, balance, and muscle strength disorders after stroke. In addition, it was determined that the functional exercise capacity of stroke patients decreased when compared to healthy individuals of the same age. The quantitative decrease in muscle mass due to physical inactivity is accompanied by sarcopenia, which worsens the situation. Although the primary impairments affecting gait are muscle strength weakness and loss of coordination, impaired cardiorespiratory fitness can also affect walking performance by limiting endurance. Depending on the change in each parameter after stroke, the functional independence and daily living activities of individuals are affected.
A correlation was found between balance and functional mobility and the level of functional independence in stroke patients. It has been found that having a good balance function after stroke significantly increases the likelihood of being functionally independent. When the studies in the literature were examined, no study was found that directly showed the relationship between functional exercise capacity and muscle strength in stroke patients. Therefore, in our study, we aimed to investigate the relationship between balance, functional exercise capacity, peripheral muscle strength, and functional independence level in stroke patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Other: Physical functions testSociodemographic information about the stroke patients included in the study will be obtained and some physical tests will be performed. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals with chronic stroke
Key inclusion criteria (7 listed)
- Having had a stroke for the first time at least 6 months ago
- Being 40 years or older
- Having a Mini-Mental Test result of more than 24 points
- The lower extremity score for Brunnstrom is 5-7
- Being 3 and above according to the functional ambulation scale
Key exclusion criteria (5 listed)
- Having a different neurological, orthopedic, and rheumatological disease
- Having a visual or hearing impairment
- Having uncontrollable cardiopulmonary and unstable chronic diseases
- Having had a transient ischemic attack or multiple strokes
- Lack of independent sitting and standing balance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical functions testParticipants; sociodemographic and descriptive data will be recorded. The Standardized Mini-Mental Test will be used for the global cognitive assessment of participants, the Brunnstrom staging to assess lower extremity motor recovery and indicate at what motor level, and the Functional Ambulation Classification to classify them according to the basic motor skills required for functional ambulation. Gait and balance assessment will be evaluated with Tinetti Balance and Gait Assessment (POMA), functional exercise capacity will be evaluated with 6 Minute Walking Test (6MWT), and peripheral muscle strength will be evaluated with knee extension strength. | Other | Study Group |
Primary outcome
Tinetti balance and walking test
Time frame: 1 day
TBGT evaluates balance ability and gait under 2 main headings: the first 9 questions are about balance and the next 7 questions are about walking. Calculation of the survey score; The total score of the first 9 items gives the balance score, the total score of the next 7 items gives the walking score, and the sum of the balance and walking scores gives the total score. Item 16 is the whole of the actions done during ADL. As a result of the evaluation made by observation, the scoring is as follows: 2 points; correct execution of the indicated movement, 1 point; performing the specified movement with adaptations, 0 points; failure to move. If the total scale score is 18 and below, it indicates a high risk of falling, a score of 19-24 indicates a moderate fall risk, and a score of 24 and above indicates a low risk of falling.
Timed up and go test (TUG)
Time frame: 1 day
TUG is a measurement that can be applied for different purposes in different age and patient groups, evaluating functional mobility, dynamic balance, fall risk, and postural stability. The activities that make up the test evaluate the transition from sitting to standing position, walking, turning, and sitting again, which are necessary for functional mobility and dynamic balance. The ZQM test measures the time it takes for an individual to get up from a standard chair with armrests and walk a distance of 3 meters, return from a designated or marked place, return to the chair, and sit back down. Widely used in clinical practice, this test is used to evaluate functional mobility, fall risk, or dynamic balance as an outcome measure and to establish normative values in the population.
Measuring peripheral muscle strength
Time frame: 1 day
Knee extensor strength as peripheral muscle strength will be measured with a portable manual muscle strength measuring device..
6-Minute Walk Test
Time frame: 1 day
The individual is asked to walk on a certain track for a period of 6 minutes. The test is performed in a closed area, on a flat surface of 30 m in length, and under the supervision of the evaluator. After six minutes, the total distance walked is recorded in meters.
Functional independence scale (FIM)
Time frame: 1 day
This scale, which is used to evaluate the level of physical activity, is an 18-item scale that evaluates 4 physical and 2 cognitive domains and consists of 6 subsections. Each item is scored between 1-7 (1: Fully assisted, 7: Completely independent), and the total score varies between 18-126 (fully dependent-fully independent).
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 15 Apr 2025.
- Derived from this study: PubMed 39593480Tutuneken YE, Yeldan I. Relation of functional independence to balance, exercise capacity, and peripheral muscle strength in individuals with chronic stroke: A cross-sectional study. J Bodyw Mov Ther. 2024 Oct;40:1514-1519. doi: 10.1016/j.jbmt.2024.08.002. Epub 2024 Aug 6.
- Individual participant dataSharing planned: Undecided
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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 Functional Independence and Balance; Distorted, run by Istinye 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 7 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 15 Apr 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?
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?
Tinetti balance and walking test (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05665673, which also lists 1 linked publication.
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 15 Apr 2025.