Stroke Clinical Trial
Official title:
The Change in Temporal Muscle Thickness and Its Relationship With Sarcopenia and Functional Outcomes in Stroke Patients.
Verified date | January 2023 |
Source | Bozyaka Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study aims to evaluate the relationship between sarcopenia and functional outcomes with temporal muscle mass change.
Status | Enrolling by invitation |
Enrollment | 150 |
Est. completion date | April 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Izmir Bozyaka Research and Training Hostpital | Izmir |
Lead Sponsor | Collaborator |
---|---|
Bozyaka Training and Research Hospital |
Turkey,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional Ambulation Scale | This scale consists of six levels of function, ranging from 0 ( non-ambulatory ) to 5 (independently ambulatory). | Baseline | |
Primary | Functional Ambulation Scale | This scale consists of six levels of function, ranging from 0 ( non-ambulatory ) to 5 (independently ambulatory). | 6. month | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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