NCT07468110

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
9mo left

Started Mar 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Mar 2026Mar 2027

First Submitted

Initial submission to the registry

March 9, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

March 10, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2027

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2027

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

March 9, 2026

Last Update Submit

March 19, 2026

Conditions

Chronic StrokeCONUT ScoreBalance AssessmentFunctional Status

Keywords

CONUT ScoreTinetti Performance-Oriented Mobility Assessment (POMA)Stroke-Specific Quality of Life Scale (SS-QOL)Rectus femoris muscle thicknessMid-upper arm circumference measurementBone Mineral Density (BMD)

Outcome Measures

Primary Outcomes (1)

  • 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.

    At baseline

Secondary Outcomes (2)

  • Tinetti Performance-Oriented Mobility Assessment

    At baseline

  • Stroke-Specific Quality of Life Scale (SS-QOL)

    At baseline

Other Outcomes (4)

  • Controlling Nutritional Status (CONUT) Score

    At baseline

  • Mid-Upper Arm Circumference (MUAC)

    At baseline

  • Rectus Femoris Muscle Thickness

    The baseline

  • +1 more other outcomes

Study Arms (1)

Patients with chronic stroke

Patients followed up in our outpatient clinics due to chronic stroke

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Faculty of Medicine Pendik Training and Research Hospital

Istanbul, Pendik, 34890, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Fatma B Akdağ

CONTACT

+90 537 452 96 60fatma.betul820@gmail.com

Özge Keniş Coşkun

CONTACT

+90 505 829 49 47ozgekenis@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 12, 2026

Study Start

March 10, 2026

Primary Completion (Estimated)

February 10, 2027

Study Completion (Estimated)

March 10, 2027

Last Updated

March 24, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)