Chronic StrokeNCT07468110
Evaluation Of The Relationship Between The Conut Score And Balance And Functional Status In Patients With Chronic Stroke
An observational study of Chronic Stroke and CONUT Score, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study is to evaluate the relationship between the CONUT score, which reflects nutritional status, and balance performance in patients with chronic stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Stroke, CONUT Score, Balance Assessment
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2026to 10 Mar 2027
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 47 patients with chronic stroke, aged between 18 and 85 years, who were followed in the Physical Medicine and Rehabilitation and Neurology outpatient clinics of Marmara University Pendik Training and Research Hospital and met the study inclusion criteria.
Who may be able to join
- Being 18 years of age or older
- Having a diagnosis of ischemic or hemorrhagic stroke
- At least 6 months having elapsed since the stroke event (chronic phase)
- Being clinically stable
- Being able to participate in standing and balance assessments (walking with an assistive device is acceptable)
- Having sufficient cognitive capacity to understand and respond to the assessment scales used in the study
- Voluntarily agreeing to participate in the study and providing written informed consent
Who cannot join
- Acute or subacute stroke phase (< 6 months)
- Inability to administer assessment scales due to severe cognitive impairment or aphasia
- Presence of other neurological disorders that may significantly affect balance and functional status (e.g., Parkinson's disease, multiple sclerosis, peripheral neuropathy)
- Significant orthopedic conditions unrelated to stroke (e.g., advanced hip or knee osteoarthritis, lower extremity amputation)
- Presence of active infection, malignancy, or systemic inflammatory disease (as these conditions may affect the CONUT score)
- Cerebellar localization of the cerebrovascular event
Show all 9Show fewer
- History of major surgery or intensive care unit admission within the past 3 months
- Inability to safely perform balance tests due to severe visual or hearing impairment
- Patients with incomplete laboratory data or insufficient information to calculate the CONUT score
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, 1 recruiting
- Recruiting
Marmara University Faculty of Medicine Pendik Training and Research Hospital
Istanbul, Pendik, 34890
Secretary General Secretary, +90 216 625 45 45, ozgekenis@gmail.com
About this study
The primary aim of this study is to evaluate the relationship between the CONUT score, which reflects nutritional status, and balance performance in patients with chronic stroke. The secondary aims are to investigate the association between the CONUT score and functional status and stroke-specific quality of life, as well as to assess the relationships of mid-upper arm circumference, an anthropometric indicator of nutritional status, and ultrasonographic rectus femoris muscle thickness, which reflects muscle mass, with balance performance, functional status, and stroke-specific quality of life. In addition, the study aims to examine the relationships between bone mineral density and balance, functional status, and ambulation level in patients with chronic stroke.
Read the detailed description
Stroke is a clinical syndrome characterized by rapidly developing neurological deficits resulting from the sudden interruption or reduction of cerebral blood flow and remains one of the leading causes of mortality and long-term disability among adults worldwide. Following the acute phase, a substantial proportion of patients transition to the chronic stage, during which persistent functional impairments such as motor deficits, balance disorders, gait limitations, and dependence in activities of daily living frequently occur.
During the post-stroke period, the risk of malnutrition increases due to factors such as dysphagia, immobility, reduced oral intake, increased catabolism, and muscle loss, all of which may negatively affect functional recovery and rehabilitation outcomes. In particular, deterioration of nutritional status in patients with chronic stroke has been reported to be associated with reduced muscle strength, impaired postural control, and increased dependence in activities of daily living.
Balance disorders in patients with chronic stroke are closely associated with reduced postural control, decreased muscle strength, and impaired sensorimotor integration. Impaired balance increases the risk of falls during the chronic phase of stroke, reduces walking speed, and limits functional independence. In addition, malnutrition characterized by decreased muscle mass and muscle function has been reported to have adverse effects on postural stability and balance performance. Therefore, evaluating the relationship between nutritional status and balance performance in patients with chronic stroke is of considerable importance for clinical management and rehabilitation strategies.
In the assessment of nutritional status, anthropometric measurements, in addition to biochemical markers, provide valuable information regarding muscle and fat tissue reserves. Mid-upper arm circumference is a simple and reliable anthropometric parameter reflecting muscle mass and peripheral tissue reserves, and it has been shown to be associated with nutritional status and functional outcomes in chronic diseases. Considering muscle loss related to immobility and asymmetric loading in stroke patients, the use of mid-upper arm circumference as a complementary indicator in evaluating the relationship between nutritional status and balance and functional status is clinically meaningful.
The Controlling Nutritional Status (CONUT) score, used to assess nutritional status, is an objective nutritional assessment index based on serum albumin level, total lymphocyte count, and total cholesterol concentration, reflecting not only nutritional status but also immunological and metabolic conditions. Although the CONUT score was initially developed for hospitalized patients, it has been shown to be associated with functional outcomes and mortality in patients with stroke. Evidence suggests that nutritional status may deteriorate from the acute phase through the chronic stage and remains clinically relevant even during the chronic phase of stroke.
In recent years, ultrasonography has increasingly been used in clinical research for the assessment of muscle mass because it is a non-invasive, radiation-free, and reproducible method. Ultrasonographic measurement of rectus femoris muscle thickness, an important antigravity muscle of the lower extremity, has been reported to be a valid and reliable indicator of muscle mass and peripheral muscle reserve and to show significant associations with muscle strength, balance performance, and walking capacity. In stroke patients, pronounced thinning of the rectus femoris muscle, particularly in the paretic lower extremity due to immobility, has been demonstrated, and this muscle loss has been associated with impaired postural control, reduced walking performance, and decreased functional independence.
During the post-stroke period, marked reductions in bone mineral density may occur due to immobility, decreased weight bearing, and reduced mechanical loading. This loss has been reported to be more pronounced on the paretic side and particularly in the hip and proximal femur regions. Loss of walking ability and low levels of weight bearing have been associated with accelerated bone mineral density loss, whereas preservation or recovery of ambulatory capacity may help limit this decline. These findings suggest that the relationship between balance, functional mobility, muscle status, and bone health may be clinically important in patients with chronic stroke.
In light of these findings, the primary aim of the present study is to evaluate the relationship between the CONUT score, reflecting nutritional status, and balance performance in patients with chronic stroke. The secondary aims are to investigate the association between the CONUT score and functional status and stroke-specific quality of life, as well as to evaluate the relationships of mid-upper arm circumference, an anthropometric indicator of nutritional status, and ultrasonographic rectus femoris muscle thickness, reflecting muscle mass, with balance performance, functional status, and stroke-specific quality of life. Additionally, the study aims to examine the relationships between bone mineral density and balance, functional status, and ambulation level in patients with chronic stroke.
- Conditions
- Chronic Stroke, CONUT Score, Balance Assessment, Functional Status
- Keywords
- CONUT Score, Tinetti Performance-Oriented Mobility Assessment (POMA), Stroke-Specific Quality of Life Scale (SS-QOL), Rectus femoris muscle thickness, Mid-upper arm circumference measurement, Bone Mineral Density (BMD)
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 |
|---|---|---|
| Patients with chronic stroke | Patients followed up in our outpatient clinics due to chronic stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
The Berg Balance Scale is a measure developed to assess individuals' balance performance and consists of 14 items that include activities of daily living. Each item is scored between 0 and 4, with the total score ranging from 0 to 56. Lower scores indicate poorer balance performance and an increased risk of falls.
Measured: At baseline
Secondary outcomes (2)
Tinetti Performance-Oriented Mobility Assessment
This measure was developed to evaluate individuals' balance and gait performance and consists of balance and gait subscales. The balance subscale is scored between 0 and 16, while the gait subscale is scored between 0 and 12, resulting in a total score ranging from 0 to 28. Lower scores indicate a higher risk of falls and poorer mobility.
Measured: At baseline
Stroke-Specific Quality of Life Scale (SS-QOL)
The Stroke-Specific Quality of Life Scale is a multidimensional measure developed to evaluate stroke-specific quality of life, encompassing physical, functional, and psychosocial domains in patients with stroke. The scale consists of a total of 49 items, each scored on a scale from 1 to 5, with higher total scores indicating a better quality of life.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start10 Mar 2026
- Primary completion10 Feb 2027 (estimated)
- Study completion10 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468110
- Sponsor's protocol ID
- 09.2026.26-0165
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of The Relationship Between The Conut Score And Balance And Functional Status In Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT07468110
- Acronym / sponsor ID
- 09.2026.26-0165
- Conditions
- Chronic Stroke, CONUT Score, Balance Assessment, Functional Status
- Keywords
- CONUT Score, Tinetti Performance-Oriented Mobility Assessment (POMA), Stroke-Specific Quality of Life Scale (SS-QOL), Rectus femoris muscle thickness, Mid-upper arm circumference measurement, Bone Mineral Density (BMD)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 10 Mar 2026 (actual)
- Primary completion
- 10 Feb 2027 (estimated)
- Study completion
- 10 Mar 2027 (estimated)
- First posted
- 12 Mar 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.
The primary aim of this study is to evaluate the relationship between the CONUT score, which reflects nutritional status, and balance performance in patients with chronic stroke. The secondary aims are to investigate the association between the CONUT score and functional status and stroke-specific quality of life, as well as to assess the relationships of mid-upper arm circumference, an anthropometric indicator of nutritional status, and ultrasonographic rectus femoris muscle thickness, which reflects muscle mass, with balance performance, functional status, and stroke-specific quality of life. In addition, the study aims to examine the relationships between bone mineral density and balance, functional status, and ambulation level in patients with chronic stroke.
Detailed description
Stroke is a clinical syndrome characterized by rapidly developing neurological deficits resulting from the sudden interruption or reduction of cerebral blood flow and remains one of the leading causes of mortality and long-term disability among adults worldwide. Following the acute phase, a substantial proportion of patients transition to the chronic stage, during which persistent functional impairments such as motor deficits, balance disorders, gait limitations, and dependence in activities of daily living frequently occur.
During the post-stroke period, the risk of malnutrition increases due to factors such as dysphagia, immobility, reduced oral intake, increased catabolism, and muscle loss, all of which may negatively affect functional recovery and rehabilitation outcomes. In particular, deterioration of nutritional status in patients with chronic stroke has been reported to be associated with reduced muscle strength, impaired postural control, and increased dependence in activities of daily living.
Balance disorders in patients with chronic stroke are closely associated with reduced postural control, decreased muscle strength, and impaired sensorimotor integration. Impaired balance increases the risk of falls during the chronic phase of stroke, reduces walking speed, and limits functional independence. In addition, malnutrition characterized by decreased muscle mass and muscle function has been reported to have adverse effects on postural stability and balance performance. Therefore, evaluating the relationship between nutritional status and balance performance in patients with chronic stroke is of considerable importance for clinical management and rehabilitation strategies.
In the assessment of nutritional status, anthropometric measurements, in addition to biochemical markers, provide valuable information regarding muscle and fat tissue reserves. Mid-upper arm circumference is a simple and reliable anthropometric parameter reflecting muscle mass and peripheral tissue reserves, and it has been shown to be associated with nutritional status and functional outcomes in chronic diseases. Considering muscle loss related to immobility and asymmetric loading in stroke patients, the use of mid-upper arm circumference as a complementary indicator in evaluating the relationship between nutritional status and balance and functional status is clinically meaningful.
The Controlling Nutritional Status (CONUT) score, used to assess nutritional status, is an objective nutritional assessment index based on serum albumin level, total lymphocyte count, and total cholesterol concentration, reflecting not only nutritional status but also immunological and metabolic conditions. Although the CONUT score was initially developed for hospitalized patients, it has been shown to be associated with functional outcomes and mortality in patients with stroke. Evidence suggests that nutritional status may deteriorate from the acute phase through the chronic stage and remains clinically relevant even during the chronic phase of stroke.
In recent years, ultrasonography has increasingly been used in clinical research for the assessment of muscle mass because it is a non-invasive, radiation-free, and reproducible method. Ultrasonographic measurement of rectus femoris muscle thickness, an important antigravity muscle of the lower extremity, has been reported to be a valid and reliable indicator of muscle mass and peripheral muscle reserve and to show significant associations with muscle strength, balance performance, and walking capacity. In stroke patients, pronounced thinning of the rectus femoris muscle, particularly in the paretic lower extremity due to immobility, has been demonstrated, and this muscle loss has been associated with impaired postural control, reduced walking performance, and decreased functional independence.
During the post-stroke period, marked reductions in bone mineral density may occur due to immobility, decreased weight bearing, and reduced mechanical loading. This loss has been reported to be more pronounced on the paretic side and particularly in the hip and proximal femur regions. Loss of walking ability and low levels of weight bearing have been associated with accelerated bone mineral density loss, whereas preservation or recovery of ambulatory capacity may help limit this decline. These findings suggest that the relationship between balance, functional mobility, muscle status, and bone health may be clinically important in patients with chronic stroke.
In light of these findings, the primary aim of the present study is to evaluate the relationship between the CONUT score, reflecting nutritional status, and balance performance in patients with chronic stroke. The secondary aims are to investigate the association between the CONUT score and functional status and stroke-specific quality of life, as well as to evaluate the relationships of mid-upper arm circumference, an anthropometric indicator of nutritional status, and ultrasonographic rectus femoris muscle thickness, reflecting muscle mass, with balance performance, functional status, and stroke-specific quality of life. Additionally, the study aims to examine the relationships between bone mineral density and balance, functional status, and ambulation level in patients with chronic stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic stroke | – | –Patients followed up in our outpatient clinics due to chronic stroke |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 47 patients with chronic stroke, aged between 18 and 85 years, who were followed in the Physical Medicine and Rehabilitation and Neurology outpatient clinics of Marmara University Pendik Training and Research Hospital and met the study inclusion criteria.
Key inclusion criteria (7 listed)
- Being 18 years of age or older
- Having a diagnosis of ischemic or hemorrhagic stroke
- At least 6 months having elapsed since the stroke event (chronic phase)
- Being clinically stable
- Being able to participate in standing and balance assessments (walking with an assistive device is acceptable)
Key exclusion criteria (9 listed)
- Acute or subacute stroke phase (< 6 months)
- Inability to administer assessment scales due to severe cognitive impairment or aphasia
- Presence of other neurological disorders that may significantly affect balance and functional status (e.g., Parkinson's disease, multiple sclerosis, peripheral neuropathy)
- Significant orthopedic conditions unrelated to stroke (e.g., advanced hip or knee osteoarthritis, lower extremity amputation)
- Presence of active infection, malignancy, or systemic inflammatory disease (as these conditions may affect the CONUT score)
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
Berg Balance Scale
Time frame: At baseline
The Berg Balance Scale is a measure developed to assess individuals' balance performance and consists of 14 items that include activities of daily living. Each item is scored between 0 and 4, with the total score ranging from 0 to 56. Lower scores indicate poorer balance performance and an increased risk of falls.
2 secondary outcomes
Tinetti Performance-Oriented Mobility Assessment
Time frame: At baseline
Stroke-Specific Quality of Life Scale (SS-QOL)
Time frame: At baseline
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 24 Mar 2026.
- Individual participant dataSharing planned: No
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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.
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 Chronic Stroke and CONUT Score, run by Marmara 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 9 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: looking for participants now, as of the sponsor's last update on 24 Mar 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?
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?
Contact Fatma B Akdağ (+90 537 452 96 60, fatma.betul820@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: At baseline). 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 24 Mar 2026.