NCT05871723

Brief Summary

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

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 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
2 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
2 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

    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.

    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)

Stroke Patients

Patients diagnosed with stroke.

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

Interventions

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.

Stroke Patients

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.

Stroke Patients

Eligibility Criteria

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

Stroke patients who gave consent to participate.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeHemiplegia

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
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

August 1, 2023

Primary Completion

October 1, 2023

Study Completion

December 1, 2023

Last Updated

May 23, 2023

Record last verified: 2023-05