NCT05829837

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

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Status
unknown

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

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

April 13, 2023

Last Update Submit

April 13, 2023

Conditions

Keywords

spinal cord injurypiriformis muscleultrasonographic evaluation

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.

Other: Ultrasonographic evaluation

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.

Other: Ultrasonographic evaluation

Interventions

Ultrasonographic evaluation for the thickness of piriformis muscle

Motor incomplete paraplegia patientsNon-ambulatory patients with complete spinal cord injury

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Özlem Köroğlu

    Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

    PRINCIPAL INVESTIGATOR

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