- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06006988
Trunk Control and Viscoelastic Properties of Trunk Muscles in Acute Stroke Patients
Investigation of the Relationship Between Trunk Control and Viscoelastic Properties of Trunk Muscles in Acute Stroke Patients
Study Overview
Detailed Description
Trunk control is the ability to maintain an upright posture, adjust weight shift, and perform selective movements in the trunk to keep the center of gravity within the base of support . Stroke is one of the main causes of impaired trunk control, including center of gravity and balance reaction . In stroke patients, trunk control ability is decreased in all planes, especially in the frontal plane. Studies have reported that stroke patients have a decrease in trunk muscle strength compared to healthy individuals , and when trunk proprioception is measured in chronic stroke patients, it is affected more than healthy participants . In addition, skeletal muscles undergo various changes after stroke. These changes that occur in the musculoskeletal system are muscle weakness, fatigue, and abnormal muscle tone . Changes at the muscle level include tissue elasticity and viscous properties. In patients with stroke, trunk control should be at a sufficient level in order to ensure functionality in the acute period. Muscle tone and viscoelasticity must be normal in order for trunk control to be at an adequate level. For this reason, in our study, the ability to control the trunk of patients with acute stroke will be associated with the viscoelastic properties of trunk muscles. Gaining a better understanding of changes in tissue distribution by looking at the viscoelasticity of trunk muscles and comparing them to the unaffected intact extremity will lead to better and more targeted interventions for rehabilitation.
The study will be carried out at Sanko University Sani Konukoğlu Practice and Research Hospital. Acute stroke patients who will voluntarily participate in the study will be included.
Inclusion criteria;
- Patients with ischemic cerebro-vascular disease within the first 72 hours,
- Patients with a National Institute of Health (NIH) score below 15
- No additional neurological and orthopedic problems
- Patients who do not have any inconvenience in sitting hemodynamically
- agree to participate in the study voluntarily Exclusion criteria;
- Patients who come to the service outside the first 72 hours
- Uncooperative patients
- patients who have had two or more strokes
- Those who have had a Trans Ischemic Attack (TIA)
- Refused to participate in the study Patients who are hospitalized from SANKO University Hospital Neurology Service will be included in the study. Socio-demographic information of the included patients will be obtained. Then, trunk impairment scale, which is a 17-item scale developed to evaluate trunk performance in stroke patients, will be used for trunk control . MyotonPro device will be used to measure the elasticity of Thoracis Longissimus, Lumbar Multifidus, Trapeze and Rectus Femoris muscles.
Demographic information form: this form is a form that evaluates the demographic information, contact information and general information of individuals.
Trunk impairment scale: It is a 17-parameter scale developed to evaluate trunk control in patients with neurological deficits . Existing sections in the scale; static sitting balance (GBÖ Static), dynamic sitting balance (GBÖ Dynamic) and coordination (GBÖ Coordination). The total score is a minimum of 0 and a maximum of 23 points and it is accepted that the higher score shows better performance. For the initial position in all items, the patients are asked to sit with the thighs parallel to the floor, feet in full contact with the ground, knees flexed to 90º, without back support, with the hands and forearms supported on the thighs. All items are repeated 3 times and the best performance of the patient is recorded. In between tests, the patient is given stimuli and verbal or visual feedback by the observer. A total score of 0 is given to individuals who cannot maintain the starting position for 10 seconds. A Turkish validity and reliability study of the GBS in stroke patients was performed .
MyotonPRO is a mobile, removable handheld myotonometer. This tool is noninvasive and provides a quantitative assessment of a muscle's viscoelastic properties. These properties are characterized by various parameters such as hardness, tone and elasticity. The probe of MyotonPRO delivers a short (15 ms), low intensity (0.58 N) mechanical impact/impact on the skin on the muscle. The response of the touch then generates a recorded signal and an internal software program generates an acceleration graph. Measurements of various viscoelastic muscle properties such as stiffness, tone, and elasticity are then extracted from this graph . Measurements of Thoracis Longissimus, Lumbar Multifidus, Trapeze and Rectus Femoris muscles will be recorded bilaterally, in 3-repetition measurements.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hakan Polat
- Phone Number: 05386487265
- Email: hakan.polat@sanko.edu.tr
Study Locations
-
-
-
Gaziantep, Turkey, 27500
- Recruiting
- SANKO University
-
Contact:
- hakan polat, Dr.
- Phone Number: 05386487265
- Email: hakan.polat@sanko.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Patients with ischemic cerebro-vascular disease within the first 72 hours,
- Patients with a National Institute of Health (NIH) score below 15
- No additional neurological and orthopedic problems
- Patients who do not have any inconvenience in sitting hemodynamically
- agree to participate in the study voluntarily
Exclusion Criteria:
- Patients who come to the service outside the first 72 hours
- Uncooperative patients
- patients who have had two or more strokes
- Those who have had a Trans Ischemic Attack (TIA)
- Refused to participate in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: trunk disorder scale
It is a 17-parameter scale developed for the evaluation of trunk control.
Existing sections in the scale; static sitting balance (GBÖ Static), dynamic sitting balance (GBÖ Dynamic) and coordination (GBÖ Coordination).
The total score is a minimum of 0 and a maximum of 23 points and it is accepted that the higher score shows better performance.
|
MyotonPRO is a mobile, removable handheld myotonometer.
This tool is noninvasive and provides a quantitative assessment of a muscle's viscoelastic properties.
These properties are characterized by various parameters such as hardness, tone and elasticity.
The probe of MyotonPRO delivers a short (15 ms), low intensity (0.58 N) mechanical impact/impact on the skin on the muscle.
The response of the touch then generates a recorded signal and an internal software program generates an acceleration graph.
Measurements of various viscoelastic muscle properties such as stiffness, tone and elasticity are then extracted from this graph.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
trunk disorder scale
Time Frame: 1 weeks
|
It is a scale consisting of 17 parameters developed for the evaluation of trunk control in patients with neurological deficits (EK8).
Existing sections in the scale; static sitting balance (GBÖ Static), dynamic sitting balance (GBÖ Dynamic) and coordination (GBÖ Coordination).
The total score is a minimum of 0 and a maximum of 23 points and it is accepted that the higher score shows better performance.
For the initial position in all items, the patients are asked to sit with the thighs parallel to the floor, feet in full contact with the ground, knees flexed to 90º, without back support, with the hands and forearms supported on the thighs.
All items are repeated 3 times and the best performance of the patient is recorded.
In between tests, the patient is given stimuli and verbal or visual feedback by the observer.
|
1 weeks
|
viscoelastic properties of muscle
Time Frame: 1 weeks
|
MyotonPRO is a mobile, removable handheld myotonometer.
This tool is noninvasive and provides a quantitative assessment of a muscle's viscoelastic properties.
These properties are characterized by various parameters such as hardness, tone and elasticity.
The probe of MyotonPRO delivers a short (15 ms), low intensity (0.58 N) mechanical impact/impact on the skin on the muscle.
The response of the touch then generates a recorded signal and an internal software program generates an acceleration graph.
Measurements of various viscoelastic muscle properties such as stiffness, tone and elasticity are then extracted from this graph.
Measurements of Thoracis Longissimus, Lumbar Multifidus, Trapeze and Rectus Femoris muscles will be recorded bilaterally, in 3-repetition measurements.
|
1 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DrHakanPolat
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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