NCT06254573

Brief Summary

introduction:The aim of this study was to show the relationship of distal femoral cartilage and quadriceps thicknesses with functional status and presence of sarcopenia in ambulatory stroke patients with voluntary movement. Materials and Method: Forty-eight patients who were diagnosed with stroke due to cerebrovascular disease, had started voluntary movement, and had a motor recovery of 3 or above according to Brunnstrom's Staging were included in this cross-sectional study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

May 10, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

8 months

First QC Date

January 24, 2024

Last Update Submit

February 3, 2024

Conditions

Hemiplegia

Keywords

Distal femoral cartilage thicknessQuadriceps muscle thicknessFunctionalitySarcopeniaHemiplegia

Outcome Measures

Primary Outcomes (2)

  • Distal Femoral Cartilage Measurement

    Horizontal imaging was performed from the suprapatellar region using the patient in the supine position with the knees at maximum flexion, and the femoral cartilage thickness was measured three times separately from 3 different locations: medial, intercondylar and lateral, and the averages were be recorded.

    once at the beginning

  • Quadriceps Femoris Muscle Thickness Measurement

    Each participant was scanned in a relaxed supine position. The examiner placed the probe on the anterior aspect of the thigh, perpendicular to its long axis at a point midway between the anterior superior iliac spine and the proximal end of the patella according to a previous study.The examiner identified the subcutaneous adipose tissue, rectus femoris, vastus intermedius, and the femur. Excess gel was applied to the skin to minimize distortion.

    once at the baseline

Secondary Outcomes (8)

  • Functional Independence Scale

    once at the beginning

  • Brunnstrom Stages of Stroke Recovery

    once at the baseline

  • Modified Ashworth Scale

    once at the baseline

  • Barthel Index for Activities of Daily Living

    once at the baseline

  • Functional Ambulation Scale

    once at the baseline

  • +3 more secondary outcomes

Eligibility Criteria

Age34 Years - 89 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who applied to Kayseri City Hospital Physical Medicine and Rehabilitation outpatient clinic and were diagnosed with clinically and radiologically confirmed stroke caused by cerebrovascular disease were included in the study after their consent was obtained. Inclusion and exclusion criteria were stated below.

You may qualify if:

  • Between 18 and 90 years old
  • Presence of a history of ischemic or hemorrhagic stroke (based on CT and/or magnetic resonance imaging (MRI) report)
  • Brunnstrom hemiplegia recovery staging, stage 3≥

You may not qualify if:

  • History of recurrent cerebrovascular accident
  • More than 2 years have passed since the history of cerebrovascular accident
  • Inflammatory arthritis or any other rheumatic disease
  • History of trauma to the knee (cruciate ligament or meniscus trauma)
  • Previous knee surgery
  • Pre-stroke neurological gait disorder
  • Lower extremity amputation
  • Knee joint contracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Health Sciences University, Kayseri Medicine Faculty

Talas, Kayseri, 38280, Turkey (Türkiye)

Location

Health Sciences University, Kayseri Medicine Faculty

Kayseri, Kocasinan, 38080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HemiplegiaSarcopenia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsAtrophyPathological Conditions, Anatomical

Study Officials

  • HAVVA TALAY ÇALIŞ

    KAYSERİ CITY HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 12, 2024

Study Start

May 10, 2022

Primary Completion

December 30, 2022

Study Completion

April 13, 2023

Last Updated

February 12, 2024

Record last verified: 2024-02

Locations

TU(2)