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Trunk Control and Viscoelastic Properties of Trunk Muscles in Acute Stroke Patients

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
myoton pro
Sponsored by
Sanko University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sanko UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

trunk disorder scale

Arm Description

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.

Outcomes

Primary Outcome Measures

trunk disorder scale
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.
viscoelastic properties of muscle
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.

Secondary Outcome Measures

Full Information

First Posted
August 1, 2023
Last Updated
August 17, 2023
Sponsor
Sanko University
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1. Study Identification

Unique Protocol Identification Number
NCT06006988
Brief Title
Trunk Control and Viscoelastic Properties of Trunk Muscles in Acute Stroke Patients
Official Title
Investigation of the Relationship Between Trunk Control and Viscoelastic Properties of Trunk Muscles in Acute Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sanko University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Stroke is a health problem that ranks second among the causes of death and third in the rate of severe disability . One of the most commonly reported problems after stroke is the structural and functional changes in the muscles . At the beginning of the structural changes of the muscles is the effect of the viscoelastic properties of the muscles. Various studies have reported an increase in skeletal muscle stiffness, which is dependent on elasticity as well as muscle viscosity after stroke . The initial condition of the affected trunk on both the ipsilateral and contralateral sides after stroke is defined as the earliest and most important factor in predicting functional recovery. Functional recovery after stroke was found to be associated with trunk control at a rate of 45-71% in general . We think that viscoelastic properties will change in trunk muscles of individuals with acute stroke and these changes may be related to trunk control disorder.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
trunk disorder scale
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
myoton pro
Intervention Description
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.
Primary Outcome Measure Information:
Title
trunk disorder scale
Description
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.
Time Frame
1 weeks
Title
viscoelastic properties of muscle
Description
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.
Time Frame
1 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hakan Polat
Phone
05386487265
Email
hakan.polat@sanko.edu.tr
Facility Information:
Facility Name
Sanko University
City
Gaziantep
ZIP/Postal Code
27500
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hakan polat, Dr.
Phone
05386487265
Email
hakan.polat@sanko.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No

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Trunk Control and Viscoelastic Properties of Trunk Muscles in Acute Stroke Patients

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