CClinicalTrials.gg
Not yet recruitingNCT05871723Updated May 23, 2023

The Relationship of Multifidus and Gastrocnemius Muscle Thickness With Postural Stability in Patients With Stroke

An observational study in Stroke, Postural; Defect and Hemiplegia, sponsored by Uskudar State Hospital. Not yet recruiting. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2023-05-23.

Sponsored by Uskudar State Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2023, 3 years ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
30
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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

Read the detailed description

Multifidus and gastrocnemius muscle thickness will be measured using ultrasound imaging. Postural stability will be assessed using the Berg Balance Scale, a clinical balance test that assesses an individual's ability to maintain balance during various functional tasks. The Berg Balance Scale includes 14 items, such as standing unsupported, reaching forward, turning, and standing on one leg. The Berg Balance Scale is a widely used clinical balance test that has good reliability and validity in stroke patients. Data will be analyzed using appropriate statistical methods, including correlation and regression analysis, to investigate the relationship between the multifidus and gastrocnemius muscle thickness and postural stability.

02

Conditions studied

  • Stroke
  • Postural; Defect
  • Hemiplegia
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 30 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Uskudar State Hospital is the lead sponsor of 27 studies on the registry; 23 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Stroke patients who gave consent to participate.

Inclusion criteria

  • Patients diagnosed with stroke: Patients who have a confirmed diagnosis of stroke based on medical history, clinical examination, and diagnostic imaging.
  • Time since stroke onset: The trial may include patients who are at least 6 months post-stroke onset.
  • Ability to understand instructions: Patients who are able to understand and follow instructions provided for the study procedures.
  • Ability to provide informed consent: Patients who are able to provide informed consent or have a legal representative who can provide informed consent on their behalf.

Exclusion criteria

Exclusion Criteria:

  • Cognitive impairment: Patients who have significant cognitive impairment that may affect their ability to follow instructions or participate in the study procedures.
  • Severe motor deficits: Patients with severe motor deficits that may limit their ability to perform the study procedures.
  • Other medical conditions: Patients with other medical conditions or comorbidities that may affect muscle thickness or postural stability, such as Parkinson's disease, multiple sclerosis, or severe osteoarthritis.
  • Inability to tolerate testing: Patients who are unable to tolerate the testing procedures, such as the Berg Balance Scale or ultrasound imaging.
  • Implanted devices: Patients with implanted devices, such as pacemakers, that may be affected by the ultrasound imaging.
  • Not giving consent.
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
30 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Stroke Patients

    Patients diagnosed with stroke.

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

Interventions

  • OtherMeasurement of multifidus and gastrocnemius muscle thickness with Ultrasound

    o 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.

  • OtherBerg Balance Scale

    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. The Berg Balance Scale is commonly used in clinical and research settings to assess balance impairment and monitor changes in balance over time, particularly in individuals with neurological conditions such as stroke. The test has good reliability and validity and is considered a gold standard for assessing balance in these populations.

06

What researchers measure

Primary outcomes

  1. Relationship between multifidus thickness and postural stability

    he 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.

    Time frame: 1 day

  2. 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.

    Time frame: 1 day

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — Individual participant data will be shared upon reasonable request by the corresponding author.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05871723
Lead sponsor
Uskudar State Hospital
Collaborators
Başakşehir Çam & Sakura City Hospital
Responsible party
Mustafa Hüseyin Temel (Principal Investigator, Uskudar State Hospital) — Principal investigator
First posted
May 23, 2023
Start date
Aug 1, 2023 (estimated)
Primary completion
Oct 1, 2023 (estimated)
Completion
Dec 1, 2023 (estimated)
Last update
May 23, 2023

Study contacts

Mustafa H Temel, M.D.
Contact
mhuseyintemel@gmail.com
+905342714872
Fatih Bağcıer, M.D.
Contact
bagcier_42@hotmail.com
05442429042
Mustafa H Temel, M.D.
principal investigator · Uskudar State Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion