The Change in Temporal Muscle Thickness in Stroke Patients

NCT05456646 | Unknown

• 1 other identifier: BITMS0722
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke; Sarcopenia

Outcome Measures

Primary Outcomes (14)

• Functional Ambulation Scale

  This scale consists of six levels of function, ranging from 0 ( non-ambulatory ) to 5 (independently ambulatory).

  Baseline

• Functional Ambulation Scale

  This scale consists of six levels of function, ranging from 0 ( non-ambulatory ) to 5 (independently ambulatory).

  6. month

• The Functional Independence Measure (FIM)

  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)

  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)

  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)

  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

  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

  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)

  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)

  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)

  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)

  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

  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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A tertiary health care facility

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bozyaka Training and Research Hospital: lead

Study Sites (1)

Izmir Bozyaka Research and Training Hostpital

Izmir, Turkey (Türkiye)

Location

Related Publications (3)

• Ryan AS, Ivey FM, Serra MC, Hartstein J, Hafer-Macko CE. Sarcopenia and Physical Function in Middle-Aged and Older Stroke Survivors. Arch Phys Med Rehabil. 2017 Mar;98(3):495-499. doi: 10.1016/j.apmr.2016.07.015. Epub 2016 Aug 13.

  PMID: 27530769 BACKGROUND

• Nozoe M, Kanai M, Kubo H, Yamamoto M, Shimada S, Mase K. Prestroke sarcopenia and functional outcomes in elderly patients who have had an acute stroke: A prospective cohort study. Nutrition. 2019 Oct;66:44-47. doi: 10.1016/j.nut.2019.04.011. Epub 2019 Apr 25.

  PMID: 31207438 BACKGROUND

• Nakanishi N, Okura K, Okamura M, Nawata K, Shinohara A, Tanaka K, Katayama S. Measuring and Monitoring Skeletal Muscle Mass after Stroke: A Review of Current Methods and Clinical Applications. J Stroke Cerebrovasc Dis. 2021 Jun;30(6):105736. doi: 10.1016/j.jstrokecerebrovasdis.2021.105736. Epub 2021 Mar 20.

  PMID: 33756264 BACKGROUND

MeSH Terms

Conditions

Stroke; Sarcopenia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Bugra Ince, MD

  Izmir Bozyaka Education and Resarch Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 13, 2022
• Study Start: July 15, 2022
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: September 5, 2023

Record last verified: 2023-01

Locations

TU (1)