Clinical trial NCT05829837: The Relationship Between Ambulation Capacity and Piriformis Muscle in Patients With Chronic Spinal Cord Injury
Official title: The Relationship Between Ambulation Capacity and Piriformis Muscle in Patients With Chronic Spinal Cord Injury: A Controlled, Clinical and Sonographic Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Cord Injuries
Keywords: spinal cord injury
piriformis muscle
ultrasonographic evaluation
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 60 patients aged 18-65 years with diagnosis of paraplegia

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.


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

Primary outcomes:
measure: piriformis muscle thickness with ultrasonographic evaluation
timeFrame: Through study completion, an average of one and a half months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
name: Özlem Köroğlu
role: PRINCIPAL_INVESTIGATOR
References: