- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07468110
Evaluation Of The Relationship Between The Conut Score And Balance And Functional Status In Patients With Chronic Stroke
Study Overview
Status
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Fatma B Akdağ
- Phone Number: +90 537 452 96 60
- Email: fatma.betul820@gmail.com
Study Contact Backup
- Name: Özge Keniş Coşkun
- Phone Number: +90 505 829 49 47
- Email: ozgekenis@gmail.com
Study Locations
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Pendik
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Istanbul, Pendik, Turkey (Türkiye), 34890
- Recruiting
- Marmara University Faculty of Medicine Pendik Training and Research Hospital
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Contact:
- Secretary General Secretary
- Phone Number: +90 216 625 45 45
- Email: ozgekenis@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Patients with chronic stroke
Patients followed up in our outpatient clinics due to chronic stroke
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg Balance Scale
Time Frame: At baseline
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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.
|
At baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tinetti Performance-Oriented Mobility Assessment
Time Frame: At baseline
|
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.
|
At baseline
|
|
Stroke-Specific Quality of Life Scale (SS-QOL)
Time Frame: At baseline
|
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.
|
At baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Controlling Nutritional Status (CONUT) Score
Time Frame: At baseline
|
The CONUT score is a laboratory-based screening index developed to assess patients' nutritional status. It is calculated using serum albumin level, total lymphocyte count, and total cholesterol concentration. Scoring is based on the combined evaluation of these three parameters, and the total score ranges from 0 to 12; higher scores indicate an increased risk of malnutrition and greater severity of nutritional impairment. |
At baseline
|
|
Mid-Upper Arm Circumference (MUAC)
Time Frame: At baseline
|
It is a simple anthropometric method that indirectly assesses an individual's muscle and adipose tissue and is commonly used to evaluate nutritional status and the risk of malnutrition.
The measurement is typically performed at the midpoint between the acromion and the olecranon using a flexible measuring tape and recorded in centimeters.
The obtained values are interpreted by comparison with age- and sex-specific reference values.
In our study, mid-upper arm circumference measurements will be obtained from both the hemiplegic and non-affected sides of the patients and evaluated comparatively.
|
At baseline
|
|
Rectus Femoris Muscle Thickness
Time Frame: The baseline
|
Rectus femoris muscle thickness is a parameter used in the assessment of muscle mass and sarcopenia and can be measured non-invasively using ultrasonography. The measurement is typically performed by placing the ultrasound probe at the midpoint between the anterior superior iliac spine and the superior border of the patella, and measuring the muscle thickness between the fascial boundaries in millimeters or centimeters. There is no standardized scoring system for this measurement; the obtained values are generally reported as absolute muscle thickness or interpreted by comparison with the contralateral side, population reference values, or clinical parameters. In our study, rectus femoris muscle thickness will be |
The baseline
|
|
Bone Mineral Densitometry (BMD)
Time Frame: At baseline
|
Bone mineral densitometry is an imaging method used to assess bone mineral density and is most commonly measured using dual-energy X-ray absorptiometry (DXA). Measurements are typically obtained from the lumbar spine and femoral neck regions, and bone mineral density is reported in g/cm². Evaluation is performed using the T-score and Z-score. A T-score ≥ -1 is considered normal, a T-score between -1 and -2.5 indicates osteopenia, and a T-score ≤ -2.5 is classified as osteoporosis. |
At baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 09.2026.26-0165
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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