NCT05871697

Brief Summary

This study aims to investigate the relationship between multifidus and gastrocnemius muscle thickness with postural stability in patients with spinal cord injury.

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 Jun 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

May 8, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

2 months

First QC Date

May 8, 2023

Last Update Submit

May 20, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Relationship between multifidus thickness and postural stability

    The relationship between multifidus muscle thickness measured by ultrasound in cm and results of berg scale will be measured statistically by calculating correlation coefficients. The Berg Balance Scale is a widely used clinical assessment tool designed to measure balance and stability in individuals who may have balance impairments due to various conditions such as stroke, Parkinson's disease, or multiple sclerosis. It consists of a series of 14 balance-related tasks that assess various aspects of balance, including sitting balance, standing balance, and dynamic balance. Each task is scored on a 5-point scale ranging from 0 to 4, with higher scores indicating better balance performance. The tasks involve different movements and challenges, such as maintaining sitting balance without arm support, standing up from a seated position, reaching forward while standing, turning around, and maintaining balance in different standing positions.

    1 day

  • Relationship between gastrocnemius muscle thickness and postural stability

    The relationship between gastrocnemius muscle thickness measured by ultrasound in cm and results of berg scale will be measured statistically by calculating correlation coefficients. The Berg Balance Scale is a widely used clinical assessment tool designed to measure balance and stability in individuals who may have balance impairments due to various conditions such as stroke, Parkinson's disease, or multiple sclerosis. It consists of a series of 14 balance-related tasks that assess various aspects of balance, including sitting balance, standing balance, and dynamic balance. Each task is scored on a 5-point scale ranging from 0 to 4, with higher scores indicating better balance performance. The tasks involve different movements and challenges, such as maintaining sitting balance without arm support, standing up from a seated position, reaching forward while standing, turning around, and maintaining balance in different standing positions.

    1 day

Study Arms (1)

Patients with spinal cord injury

Patients who have spinal cord injury.

Other: Measurement of multifidus and gastrocnemius muscle thickness with UltrasoundOther: Berg Balance Scale

Interventions

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.

Patients with spinal cord injury

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.

Patients with spinal cord injury

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have spinal cord injury that gave consent to participate.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Mustafa H Temel, M.D.

    Uskudar State Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa H Temel, M.D.

CONTACT

Fatih Bağcıer, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 8, 2023

First Posted

May 23, 2023

Study Start

June 1, 2023

Primary Completion

August 1, 2023

Study Completion

December 1, 2023

Last Updated

May 23, 2023

Record last verified: 2023-05