Multifidus & Gastrocnemius Muscle Thickness & Postural Stability in Spinal Cord Injury Patients: A Correlational Study

NCT ID: NCT05871697

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-06-01
• 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 spinal cord injury.

Detailed Description

Ultrasound imaging will be used to measure multifidus and gastrocnemius muscle thickness in patients with spinal cord injury. Postural stability will be assessed using the Berg Balance Scale, a clinical balance test consisting of 14 items that evaluate an individual's ability to maintain balance during various functional tasks such as standing unsupported, reaching forward, turning, and standing on one leg. The Berg Balance Scale is a reliable and valid clinical balance test that is commonly used in spinal cord injury patients. Statistical methods, including correlation and regression analysis, will be used to analyze the data and investigate the relationship between the multifidus and gastrocnemius muscle thickness and postural stability.

Conditions

Spinal Cord Injuries

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with spinal cord injury

Patients who have spinal cord injury.

Measurement of multifidus and gastrocnemius muscle thickness with Ultrasound

Intervention Type: OTHER

To 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.

Interventions

Measurement of multifidus and gastrocnemius muscle thickness with Ultrasound

To 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with a confirmed diagnosis of spinal cord injury at least 6 months prior to study enrollment.
• Patients who are able to follow instructions and comply with study procedures.

Exclusion Criteria

• Patients with severe cognitive impairment or inability to follow instructions.
• Patients with other medical conditions that may affect muscle thickness or postural stability, such as Parkinson's disease, multiple sclerosis, or severe osteoarthritis.
• Patients with contraindications for ultrasound imaging, such as pregnancy or implanted devices that may be affected by the imaging.
• Patients with severe motor deficits that may limit their ability to perform the study procedures.
• Patients who are unable to tolerate the testing procedures, such as the Berg Balance Scale or ultrasound imaging.

• 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

SKLPosture1

Identifier Type: -

Identifier Source: org_study_id