- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06059482
The Effect of Trunk Control on Sitting Balance and Upper Extremity Functions in Patients With Subacute Stroke
Study Overview
Detailed Description
Patients who meet the inclusion and exclusion criteria will be informed about the study and the participants who agree to participate in the study will be given the "Mini-Mental Test" and "Brunnstrom Upper Extremity Staging" tests, respectively. Then, Trunk Impairment Scale, Trunk Control Test, Function in Sitting Test, and "Fugl Meyer Upper Extremity Test" will be applied respectively.
Thirty patients with stroke will included in the study. Trunk Impairment Scale and Trunk Control Test will used to assess trunk control assessment. Fugl-Meyer Assessment of the upper extremity will used to assess upper extremity. Function in Sitting Test will used to assess sitting balance. To evaluate between correlation trunk control and upper extremity and sitting balance will used to correlation analysis tests
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Merkez
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Kütahya, Merkez, Turkey, 43100
- Kütahya Health Sciences University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Being diagnosed with stroke and being in the subacute period (stroke onset time is between 0-6 months),
- Over 18 years old,
- Mini-Mental Test score ≥ 24 points,
- Able to sit independently in a chair for 10 minutes
- To be able to understand and follow simple explanations.
Exclusion Criteria:
- Having been diagnosed with a brain stem or cerebellar stroke,
- Having neurological or orthopedic pathology,
- Having acute low back pain,
- Having undergone surgery in the last 6 months,
- Having neglect, aphasia and heminanopsis.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trunk Impairment Scale
Time Frame: Baseline (First assessment)
|
It is a scale developed for the evaluation of the trunk after stroke. It consists of 3 parts:static sitting balance, dynamic sitting balance and coordination. A maximum of 23 points can be obtained, 3 from the static section, 10 from the dynamic section, and 4 from the coordination section. Except for the coordination part, each part is evaluated bilaterally. |
Baseline (First assessment)
|
Trunk Control Test
Time Frame: Baseline (First assessment)
|
Trunk Control Test is a test developed to evaluate trunk control.
It consists of 4 parts.
The test consists of the parameters of turning from the supine position to the weak and strong side, coming from the supine position to the sitting position and maintaining the sitting balance.
The scoring of each section is 0-12-25.
The total score is between 0-100.
Higher scores indicate better trunk control of the patient.
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Baseline (First assessment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fugl-Meyer Assessment
Time Frame: Baseline (First assessment)
|
The Fugl-Meyer Assessment is a disease-specific impairment index designed to assess motor function, balance, sensation qualities and joint function in hemiplegic post-stroke patients.The scale consists of four categories (Shoulder/Elbow/Forearm, Wrist, Hand/Finger, and Coordination) and evaluates 23 different movements in 33 sections.The maximum score is 66 points
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Baseline (First assessment)
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Function in Sitting Test (FIST)
Time Frame: Baseline (First assessment)
|
The FIST is a clinical examination of sitting balance, designed to be conducted at the patient's bedside.
Consists of 14 functional, everyday activities as test items.
Each item of the test is scored between 0-4.
The total score range of FIST is 0-56.
|
Baseline (First assessment)
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Collaborators and Investigators
Investigators
- Study Director: Lütfiye AKKURT, PhD, Kütahya Health Sciences University
- Study Chair: Güllü A YAGCIOĞLU, PhD, Saglik Bilimleri Universitesi
- Study Chair: Cihan Caner AKSOY, PhD, Kütahya Health Sciences University
- Study Chair: Fatıma YAMAN, MD, Kütahya Health Sciences University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- 2023/06-10
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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