The Relationship of Multifidus and Gastrocnemius Muscle Thickness With Postural Stability in Patients With Stroke

NCT ID: NCT05871723

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2023-12-01

Brief Summary

This study aims to investigate the relationship between multifidus and gastrocnemius muscle thickness with postural stability in patients with stroke.

Detailed Description

Multifidus and gastrocnemius muscle thickness will be measured using ultrasound imaging. Postural stability will be assessed using the Berg Balance Scale, a clinical balance test that assesses an individual's ability to maintain balance during various functional tasks. The Berg Balance Scale includes 14 items, such as standing unsupported, reaching forward, turning, and standing on one leg. The Berg Balance Scale is a widely used clinical balance test that has good reliability and validity in stroke patients. Data will be analyzed using appropriate statistical methods, including correlation and regression analysis, to investigate the relationship between the multifidus and gastrocnemius muscle thickness and postural stability.

Conditions

Stroke; Postural; Defect; Hemiplegia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Stroke Patients

Patients diagnosed with stroke.

Measurement of multifidus and gastrocnemius muscle thickness with Ultrasound

Intervention Type: OTHER

o measure multifidus and gastrocnemius muscle thickness using ultrasound imaging, the following steps are typically followed. First, the patient is positioned appropriately to allow access to the muscles to be imaged. For example, the patient may lie prone for imaging of the lumbar multifidus or sit with the leg extended for imaging of the gastrocnemius. Next, a trained clinician or technician places an ultrasound probe on the skin over the target muscle and adjusts the settings on the ultrasound machine to optimize the image quality. The probe is then moved around to obtain different views of the muscle, and the images are stored for later analysis. To measure muscle thickness, the clinician or technician identifies the muscle fascia on the ultrasound image and measures the distance between the fascia and the underlying bone or tissue. This measurement provides an estimate of the muscle thickness.

Berg Balance Scale

Intervention Type: OTHER

The Berg Balance Scale is a clinical assessment tool used to measure an individual's ability to maintain balance during various functional tasks. The test includes 14 items, such as standing unsupported, reaching forward, turning, and standing on one leg. Each item is scored on a 5-point scale, ranging from 0 (unable to perform the task) to 4 (able to perform the task independently and safely). The scores for each item are summed to provide a total score, with a maximum possible score of 56. The Berg Balance Scale is commonly used in clinical and research settings to assess balance impairment and monitor changes in balance over time, particularly in individuals with neurological conditions such as stroke. The test has good reliability and validity and is considered a gold standard for assessing balance in these populations.

Interventions

Measurement of multifidus and gastrocnemius muscle thickness with Ultrasound

o measure multifidus and gastrocnemius muscle thickness using ultrasound imaging, the following steps are typically followed. First, the patient is positioned appropriately to allow access to the muscles to be imaged. For example, the patient may lie prone for imaging of the lumbar multifidus or sit with the leg extended for imaging of the gastrocnemius. Next, a trained clinician or technician places an ultrasound probe on the skin over the target muscle and adjusts the settings on the ultrasound machine to optimize the image quality. The probe is then moved around to obtain different views of the muscle, and the images are stored for later analysis. To measure muscle thickness, the clinician or technician identifies the muscle fascia on the ultrasound image and measures the distance between the fascia and the underlying bone or tissue. This measurement provides an estimate of the muscle thickness.

Intervention Type: OTHER

Berg Balance Scale

The Berg Balance Scale is a clinical assessment tool used to measure an individual's ability to maintain balance during various functional tasks. The test includes 14 items, such as standing unsupported, reaching forward, turning, and standing on one leg. Each item is scored on a 5-point scale, ranging from 0 (unable to perform the task) to 4 (able to perform the task independently and safely). The scores for each item are summed to provide a total score, with a maximum possible score of 56. The Berg Balance Scale is commonly used in clinical and research settings to assess balance impairment and monitor changes in balance over time, particularly in individuals with neurological conditions such as stroke. The test has good reliability and validity and is considered a gold standard for assessing balance in these populations.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with stroke: Patients who have a confirmed diagnosis of stroke based on medical history, clinical examination, and diagnostic imaging.
• Time since stroke onset: The trial may include patients who are at least 6 months post-stroke onset.
• Ability to understand instructions: Patients who are able to understand and follow instructions provided for the study procedures.
• Ability to provide informed consent: Patients who are able to provide informed consent or have a legal representative who can provide informed consent on their behalf.

Exclusion Criteria

• Cognitive impairment: Patients who have significant cognitive impairment that may affect their ability to follow instructions or participate in the study procedures.
• Severe motor deficits: Patients with severe motor deficits that may limit their ability to perform the study procedures.
• Other medical conditions: Patients with other medical conditions or comorbidities that may affect muscle thickness or postural stability, such as Parkinson's disease, multiple sclerosis, or severe osteoarthritis.
• Inability to tolerate testing: Patients who are unable to tolerate the testing procedures, such as the Berg Balance Scale or ultrasound imaging.
• Implanted devices: Patients with implanted devices, such as pacemakers, that may be affected by the ultrasound imaging.
• Not giving consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Başakşehir Çam & Sakura City Hospital

OTHER_GOV

Sponsor Role: collaborator

Uskudar State Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mustafa Hüseyin Temel

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mustafa H Temel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Uskudar State Hospital

Central Contacts

Mustafa H Temel, M.D.

Role: CONTACT

mhuseyintemel@gmail.com

+905342714872

Fatih Bağcıer, M.D.

Role: CONTACT

bagcier_42@hotmail.com

05442429042

Other Identifiers

SVOposture1

Identifier Type: -

Identifier Source: org_study_id