The Relationship Between Ambulation Capacity and Piriformis Muscle in Patients With Chronic Spinal Cord Injury

NCT ID: NCT05829837

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2023-11-01

Brief Summary

Spinal cord injury (SCI) is a neurological condition causing paralysis, sensory abolishmentS and deficits including circulatory, respiratory, otonomic nervous systems, bowel and bladder functions. For patients with SCI, reducing disability, limitations of the impairment and regaining the walking ability are the main rehabilitation goals. There many prognostic factors effecting the recovery and ambulation capacity of patients.

The piriformis muscle (PM) is placed posterior to the hip joint, originates on the anterior surface of the sacrum and the sacrotuberous ligament and passes out of the pelvis through the greater sciatic foramen and separates the foramen into two spaces. The PM is the solely muscle coursing transversely throughout the greater sciatic notch, and it is the main landmark to all the important neurovasculer structures that pass from the pelvis to the gluteal region. PM serves as a hip abductor when the hip is flexed and as a hip external rotator when the hip is extended. It is innervated by branches of the posterior division of the ventral rami of S1, S2 and is the largest muscle among the deep, short external rotators of the hip and provides postural stability while standing and walking. PM has also a functional importance as it connects the sacroiliac joint and hip joint. For these reasons morphology of PM may have a clinical importance for SCI patients whom can walk.

Ultrasonography is radiation-free, noninvasive, available technique that can be used to measure muscle thickness in the monitoring and management of muscle changes during rehabilitation.

The aim of our study is to evaluate the relationship between the PM and the ambulation pattern of motor incomplete patients with chronic SCI. To the best of our knowledge, this is the first study evaluating PM in patients with SCI.

Conditions

Spinal Cord Injuries

Study Design

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

Study Groups

Motor incomplete paraplegia patients

Participants with the age of 18 - 65, were selected for the study based on the following inclusion criteria: diagnosis of motor incomplete paraplegia at C or D level according to the spinal cord injury classification of the American Spinal Injury Association (ASIA) Impairment Scale with a neurological injury level between T2-S1.

Ultrasonographic evaluation

Intervention Type: OTHER

Ultrasonographic evaluation for the thickness of piriformis muscle

Non-ambulatory patients with complete spinal cord injury

Participants with the age of 18 - 65, were selected for the study based on the following inclusion criteria: non-ambulatory patients with diagnosis of motor complete paraplegia at A level according to the spinal cord injury classification of the American Spinal Injury Association (ASIA) Impairment Scale with a neurological injury level between T2-S1.

Ultrasonographic evaluation

Intervention Type: OTHER

Ultrasonographic evaluation for the thickness of piriformis muscle

Interventions

Ultrasonographic evaluation

Ultrasonographic evaluation for the thickness of piriformis muscle

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Being between the ages of 18-65
• Diagnosis of motor incomplete paraplegia at C or D level according to the spinal cord injury classification of the American Spinal Injury Association (ASIA) Impairment Scale with a neurological injury level between T2-S1

Exclusion Criteria

• Being under the age of 18 and over the age of 65
• Having joint contracture in the legs
• Unstable medical conditions
• Severe osteoporosis and high fracture risk
• Sacral or coccygeal grade 2 and higher pressure ulcers
• Peripheral neuropathy,
• Psychiatric disorder or cognitive problems

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yasin Demir

Physical Medicine and Rehabilitation Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Özlem Köroğlu

Role: PRINCIPAL_INVESTIGATOR

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Central Contacts

Özlem Köroğlu

Role: CONTACT

drozlemkoroglu@gmail.com

+905056005504

Other Identifiers

37

Identifier Type: -

Identifier Source: org_study_id