The Relationship Between Ambulation Capacity and Piriformis Muscle in Patients With Chronic Spinal Cord Injury
1 other identifier
observational
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2023
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2023
CompletedFirst Posted
Study publicly available on registry
April 26, 2023
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedApril 26, 2023
April 1, 2023
6 months
April 13, 2023
April 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
piriformis muscle thickness with ultrasonographic evaluation
The thickness of piriformis muscle was measured by using a curvilinear transducer first placing in the lateral margin of the sacrum. The transducer was moved inferolaterally toward the greater trochanter until the medial end of the transducer remained at the lateral end of the sacrum. Piriformis muscle thickness was measured in the medial part of the tip of the ischium, that was parallel to the longitudinal plane at the sciatic notch with the patient's leg was abducted 45 degrees when the piriformis muscle was seen as a deep hypoechoic appearance beneath the gluteus maximus muscle.
Through study completion, an average of one and a half months
Study Arms (2)
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.
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.
Interventions
Ultrasonographic evaluation for the thickness of piriformis muscle
Eligibility Criteria
60 patients aged 18-65 years with diagnosis of paraplegia
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Özlem Köroğlu
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physical Medicine and Rehabilitation Specialist
Study Record Dates
First Submitted
April 13, 2023
First Posted
April 26, 2023
Study Start
May 1, 2023
Primary Completion
November 1, 2023
Study Completion
November 1, 2023
Last Updated
April 26, 2023
Record last verified: 2023-04