NCT04042818

Brief Summary

The purpose of the study is search the interrater and intrarater reliability of the quadriceps muscle using rehabilitative ultrasound imaging and search for an association between sarcopenia and quadriceps muscle in poststroke patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2019

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

August 2, 2019

Status Verified

July 1, 2019

Enrollment Period

6 months

First QC Date

July 20, 2019

Last Update Submit

July 31, 2019

Conditions

SarcopeniaStroke, ComplicationQuadriceps Muscle AtrophyHemiplegiaUltrasonographyHand Strength

Keywords

SarcopeniaStrokeQuadriceps Muscle AtrophyHemiplegiaUltrasonographyHand Strength

Outcome Measures

Primary Outcomes (3)

  • Thickness of Rectus Femoris Muscle

    Longitudinal and Transverse thickness of rectus femoris muscle

    One week

  • Thickness of vastus intermedius muscle

    Longitudinal and Transverse thickness of vastus intermedius muscle

    One week

  • Cross-sectional area of Rectus Femoris Muscle

    Cross-sectional area of Rectus Femoris Muscle

    One week

Interventions

Rehabilitative UltrasoundDIAGNOSTIC_TEST

Ultrasound imagining

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Poststroke patients

You may qualify if:

  • Poststroke patients (\>6 months)

You may not qualify if:

  • \< 6 months after stroke
  • Multiple stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpasa Taksim Training and Research Hospital

Istanbul, 34255, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

SarcopeniaStrokeHemiplegia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysis

Study Officials

  • Ebru Y Yalçınkaya, M.D.

    Gaziosmanpasa Taksim Training and Research Hospital

    STUDY DIRECTOR

Central Study Contacts

Mehmet A Guler, M.D.

CONTACT

+905054930098makifguler89@gmail.com

Zeynel Karakullukçuoğlu, M.D.

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 20, 2019

First Posted

August 2, 2019

Study Start

July 1, 2019

Primary Completion

December 30, 2019

Study Completion

January 30, 2020

Last Updated

August 2, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)