The Change in Temporal Muscle Thickness in Stroke Patients

September 1, 2023 updated by: Bozyaka Training and Research Hospital

The Change in Temporal Muscle Thickness and Its Relationship With Sarcopenia and Functional Outcomes in Stroke Patients.

This study aims to evaluate the relationship between sarcopenia and functional outcomes with temporal muscle mass change.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

It is well known that stroke increases the risk of developing sarcopenia . In addition, prestroke sarcopenia is associated with worse functional outcomes in patients with stroke. Temporal muscle thickness (TMT) has recently been proposed as a new marker of whole-body muscle mass and function. Measurement of temporal muscle mass by computed tomography (CT) and magnetic resonance imaging (MRI) has been studied in the literature in recent years. All stroke patients undergo cranial CT or MRI examinations at the time of admission. By evaluating the temporal muscle mass of these patients with these examinations, information about pre-stroke muscle mass and sarcopenia can be obtained. Ultrasonography (USG), on the other hand, may be a more accessible, less expensive, and safer option for assessing muscle mass in the follow-up of stroke patients. This study aims to evaluate the relationship between sarcopenia and functional outcomes with temporal muscle mass change by MRI/CT at admission and by USG in the chronic period.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İzmir, Turkey
        • Izmir Bozyaka Research and Training Hostpital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A tertiary health care facility

Description

Inclusion Criteria:

  • Diagnosis of stroke
  • Presence of cranial MRI/CT in hospital records

Exclusion Criteria:

  • Medically unstable condition (presence or high risk of impaired consciousness, respiration, or circulation).
  • Severe cognitive impairment
  • Patients who require intensive care unit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Ambulation Scale
Time Frame: Baseline
This scale consists of six levels of function, ranging from 0 ( non-ambulatory ) to 5 (independently ambulatory).
Baseline
Functional Ambulation Scale
Time Frame: 6. month
This scale consists of six levels of function, ranging from 0 ( non-ambulatory ) to 5 (independently ambulatory).
6. month
The Functional Independence Measure (FIM)
Time Frame: Baseline
FIM is a scale that assesses 18 activities, including self-care, sphincter control, transfer, movement, communication, and social awareness. Total scores range from 18 to 126 (dependent in all domains - independent in all domains).
Baseline
The Functional Independence Measure (FIM)
Time Frame: 6.month
FIM is a scale that assesses 18 activities, including self-care, sphincter control, transfer, movement, communication, and social awareness. Total scores range from 18 to 126 (dependent in all domains - independent in all domains).
6.month
Modified Rankin Scale (mRS)
Time Frame: Baseline
It categorizes poststroke disability into six levels ranging from 0 to 5, with absence of symptoms rated as 0 and severe disability or bedriddenness rated as 5. An mRS score of 2 or less was defined as a good outcome, and an mRS score above 2 was defined as a poor outcome.
Baseline
Modified Rankin Scale (mRS)
Time Frame: 6. month
It categorizes poststroke disability into six levels ranging from 0 to 5, with absence of symptoms rated as 0 and severe disability or bedriddenness rated as 5. An mRS score of 2 or less was defined as a good outcome, and an mRS score above 2 was defined as a poor outcome.
6. month
Handgrip strength
Time Frame: Baseline
With the JAMAR Hand Dynamometer, 3 measurements will be taken for both hands 60 seconds apart in the standard position and the highest reading will be recorded.
Baseline
Handgrip strength
Time Frame: 6. month
With the JAMAR Hand Dynamometer, 3 measurements will be taken for both hands 60 seconds apart in the standard position and the highest reading will be recorded.
6. month
Dual energy X-ray absorptiometry (DEXA)
Time Frame: Baseline
DEXA can be used to determine lean body mass and total body fat. The appendicular skeletal mass index will be used in the evaluation of sarcopenia and in other analyzes.
Baseline
Dual energy X-ray absorptiometry (DEXA)
Time Frame: 6.month
DEXA can be used to determine lean body mass and total body fat. The appendicular skeletal mass index will be used in the evaluation of sarcopenia and in other analyzes.
6.month
Bioelectrical impedance analysis (BIA)
Time Frame: Baseline
Body water mass, total body fat, and muscle mass can be determined with BIA.The appendicular skeletal mass index will be used in the evaluation of sarcopenia and in other analyzes.
Baseline
Bioelectrical impedance analysis (BIA)
Time Frame: 6.month
Body water mass, total body fat, and muscle mass can be determined with BIA.The appendicular skeletal mass index will be used in the evaluation of sarcopenia and in other analyzes.
6.month
Functional Oral Intake Scale
Time Frame: Baseline
The scale is rated with values between 1 and 7. Level 1-3 refers to tube-dependent feeding, level 4-6 to full oral feeding with restrictions, and level 7 to oral feeding without restrictions.
Baseline
Functional Oral Intake Scale
Time Frame: 6. month
The scale is rated with values between 1 and 7. Level 1-3 refers to tube-dependent feeding, level 4-6 to full oral feeding with restrictions, and level 7 to oral feeding without restrictions.
6. month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bozyaka Training and Research Hospital

Investigators

  • Principal Investigator: Bugra Ince, MD, Izmir Bozyaka Education and Resarch Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2022

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

July 11, 2022

First Submitted That Met QC Criteria

July 11, 2022

First Posted (Actual)

July 13, 2022

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

September 1, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BITMS0722

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

upon request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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