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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06059482
Other study ID # 2023/06-10
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 5, 2023
Est. completion date March 8, 2024

Study information

Verified date June 2023
Source Kutahya Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study aims to examine whether trunk control affects sitting balance and upper extremity functions in patients with subacute stroke.


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


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date March 8, 2024
Est. primary completion date March 7, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Assessment
Evaluations will be made once.

Locations

Country Name City State
Turkey Kutahya Health Sciences University Kütahya Merkez

Sponsors (1)

Lead Sponsor Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Trunk Impairment Scale 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)
Primary Trunk Control Test 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. Baseline (First assessment)
Secondary Fugl-Meyer 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 Baseline (First assessment)
Secondary Function in Sitting Test (FIST) 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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