The Change in Temporal Muscle Thickness in Stroke Patients

• Conditions: Stroke; Sarcopenia

• Registration Number: NCT05456646
• Lead Sponsor: Bozyaka Training and Research Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-07-11
• Study First Submitted QC: 2022-07-11
• Study First Posted: 2022-07-13
• Study Start: 2022-07-15
• Status Verified: 2023-01
• Last Update Submitted: 2023-09-01
• Last Update Posted: 2023-09-05
• Primary Completion: 2024-03
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional Ambulation Scale	6. month	This scale consists of six levels of function, ranging from 0 ( non-ambulatory ) to 5 (independently ambulatory).
Modified Rankin Scale (mRS)	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.
Functional Oral Intake Scale	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.
Dual energy X-ray absorptiometry (DEXA)	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.
Bioelectrical impedance analysis (BIA)	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.
The Functional Independence Measure (FIM)	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).
Handgrip strength	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.

Trial Locations

Locations (1)

Izmir Bozyaka Research and Training Hostpital; 🇹🇷 İzmir, Turkey