NCT07734506

Brief Summary

The aim of this study is to evaluate the relationship between ultrasonography-measured quadriceps muscle thickness and the sarcopenia markers SARC-F questionnaire and handgrip strength in patients diagnosed with ischemic stroke. In addition, the relationship between quadriceps muscle thickness and the level of kinesiophobia will be quantitatively assessed. This study is a cross-sectional clinical study conducted between August 1, 2025, and August 1, 2026, at the Physical Medicine and Rehabilitation Clinic of the University of Health Sciences İstanbul Physical Medicine and Rehabilitation Training and Research Hospital. Fifty volunteer participants with ischemic stroke and a lower-extremity Brunnstrom motor stage of 3 or higher, who presented to the clinic during the study period, were included. Bilateral quadriceps femoris muscle thickness, including the rectus femoris and vastus intermedius muscles, was measured using ultrasonography. The SARC-F questionnaire was used to assess sarcopenia risk, handgrip strength measurement was used to evaluate muscle strength, and the Tampa Scale for Kinesiophobia was used to determine the level of kinesiophobia. Motor recovery stage was assessed using the Brunnstrom Staging system; motor and cognitive independence were assessed using the Functional Independence Measure; walking independence was assessed using the Functional Ambulation Scale; and independence in activities of daily living was assessed using the Barthel Index of Activities of Daily Living. Because balance impairment, muscle weakness, and limited mobility are common after stroke, physical performance tests may be difficult to administer safely and consistently in this patient population. Therefore, the relationship between quadriceps muscle thickness and physical performance tests was not evaluated in this study. The Chair Stand Test, which requires repeated sit-to-stand movements as well as adequate balance and lower-extremity muscle strength, was also not included because it may increase the risk of falls in patients with limited mobility. This study aims to demonstrate the clinical potential of ultrasonography in the assessment of post-stroke sarcopenia and to support a more holistic approach to stroke rehabilitation planning that considers both physical and psychological factors.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 29, 2026

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

July 29, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 21, 2026

Last Update Submit

July 27, 2026

Conditions

Keywords

Quadriceps Muscle ThicknessUltrasonographySarcopeniaSARC-FHandgrip StrengthKinesiophobiaStroke Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Quadriceps Muscle Thickness

    Bilateral quadriceps femoris muscle thickness (rectus femoris and vastus intermedius) measured by ultrasonography

    Measured once at the time of study enrollment (baseline, cross-sectional assessment). Within this single session, three consecutive measurements were obtained per participant, and the mean value was recorded as the outcome value

Secondary Outcomes (3)

  • SARC-F Score

    Measured once at the time of study enrollment

  • Handgrip Strength

    Measured once at the time of study enrollment (baseline, cross-sectional assessment). Within this single session, three consecutive measurements were obtained per participant, and the highest value was recorded as the outcome value

  • Tampa Scale for Kinesiophobia Score

    Measured once at the time of study enrollment

Study Arms (1)

Ischemic Stroke Patients

Fifty volunteer participants diagnosed with ischemic stroke, admitted to the Physical Medicine and Rehabilitation Clinic of the University of Health Sciences Istanbul Physical Medicine and Rehabilitation Training and Research Hospital between August 1, 2025 and August 1, 2026, were included. Inclusion criteria were: chronic stroke duration between 6 months and 2 years, ischemic stroke type, age between 40-80 years, Brunnstrom lower extremity motor stage ≥3 with ambulatory status, and provision of written informed consent. Patients with hemorrhagic stroke, stroke onset more than 2 years prior, inflammatory arthritis or other rheumatologic disease, history of knee trauma, pre-stroke neurological gait disorder, recurrent stroke, lower extremity amputation, or knee joint contracture were excluded.

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic ischemic stroke who presented to the Physical Medicine and Rehabilitation Clinic of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital.

You may qualify if:

  • Chronic stroke duration between 6 months and 2 years
  • Ischemic stroke type
  • Age between 40-80 years
  • Brunnstrom lower extremity motor stage ≥3, ambulatory
  • Provision of written informed consent

You may not qualify if:

  • Hemorrhagic stroke
  • Stroke onset more than 2 years prior
  • Inflammatory arthritis or other rheumatologic disease
  • History of knee trauma
  • Pre-stroke neurological gait disorder
  • Recurrent stroke
  • Lower extremity amputation
  • Knee joint contracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

Istanbul, Istanbul, 34180, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Cigercioglu N, Bazancir Apaydin Z, Apaydin H, Guney H. The relationship between kinesiophobia and muscle architectural characteristics and functional tests in women with knee osteoarthritis: an analytical study. Turkiye Klinikleri Journal of Health Sciences. 2024;9(1). doi:10.5336/healthsci.2024-101654.

    BACKGROUND
  • Rech A, Radaelli R, Goltz FR, da Rosa LH, Schneider CD, Pinto RS. Echo intensity is negatively associated with functional capacity in older women. Age (Dordr). 2014;36(5):9708. doi: 10.1007/s11357-014-9708-2. Epub 2014 Aug 29.

    PMID: 25167965BACKGROUND
  • Gomes TLN, Borges TC, Pichard C, Pimentel GD. Correlation between SARC-F Score and Ultrasound-Measured Thigh Muscle Thickness in Older Hospitalized Cancer Patients. J Nutr Health Aging. 2020;24(10):1128-1130. doi: 10.1007/s12603-020-1524-z.

    PMID: 33244572BACKGROUND

MeSH Terms

Conditions

StrokeSarcopeniaKinesiophobia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • ALPEREN KOLUKISAOĞLU, MD

    Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

    PRINCIPAL INVESTIGATOR
  • NUR KESİKTAŞ, MD, Professor

    Istanbul Physical Medicine and Rehabilitation Training and Research Hospital

    STUDY CHAIR

Central Study Contacts

ALPEREN KOLUKISAOĞLU, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 21, 2026

First Posted

July 29, 2026

Study Start

August 1, 2025

Primary Completion

August 1, 2026

Study Completion

August 1, 2026

Last Updated

July 29, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared as there is currently no plan or infrastructure in place for external data sharing. The data collected in this study will be used solely for the purposes of this thesis research and any related publications. No mechanism for de-identified data transfer or a data sharing agreement has been established. This decision may be reconsidered in the future if a formal data sharing framework becomes available at the institutional level.

Locations