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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06272175
Other study ID # 10102023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 4, 2024
Est. completion date December 30, 2024

Study information

Verified date March 2024
Source Istinye University
Contact Çiçek GÜNDAY, PhD(c)
Phone +90 507 188 8848
Email cckdmn@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Stroke is a sudden disruption of blood flow to the brain, resulting in physical and mental disabilities. It's a global health issue affecting millions each year, often leading to paralysis, altered muscle tone, and loss of motor control and balance. This study aims to examine the immediate effects of open and closed kinetic chain activites on upper extremity spasticity and motor dexterity in hemiplegic patients. This study will be conducted simultaneously at İstinye University Hospital Medical Park Gaziosmanpaşa and İstinye University Physiotherapy and Rehabilitation Application and Research Center (İSÜFİZYOTEM). 50 stroke patients will be included in the study, and all participants will be asked to sign an informed consent form. At the beginning of the session, all participants will be evaluated for their socio-demographic characteristics by a questionnaire created by the researchers, muscle viscoelastic properties by MyotonPRO, upper extremity muscle tone by Modified Ashworth Scale, upper extremity motor dexterity by Box and Block Test, and upper extremity joint range of motion by goniometer and by a phone application named as PhysioMaster. After the assessment, participants will be randomly assigned to two groups: open kinetic chain activity group and closed kinetic chain activity group. After performing the exercises, all evaluations will be conducted again. Thus, the aim is to understand the immediate effects of two different group exercises on the evaluated parameters.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Stroke diagnosis; - Hemiplegia; - Subacute&chronic phase (more than 3 months); - Brunnstrom 3-4-5; - Unsupported sitting ability; - Being volunteer. Exclusion Criteria: - Having Botox within the last 6 months; - 4 according to Modified Ashworth Scale; - Other neurological diagnosis other than stroke.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Open Kinetic Chain Activity
PNF Flexion-Abduction-External Rotation and Flexion-Adduction-External Rotation patterns will be actively performed on the hemiplegic upper extremity.
Closed Kinetic Chain Activity
Weight-bearing on the hemiplegic hand with extended elbow in standing position

Locations

Country Name City State
Turkey Istinye University Hospital Medical Park Gaziosmanpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istinye University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary MyotonPRO digital palpation device This device is a patented, certified, digital measurement device that measures the amount of tissue displacement that occurs per unit force applied by a probe pressed perpendicularly to the skin overlying the muscle. It measures the viscoelastic properties of the muscles. Latissimus Dorsi will be measured from a point 5 cm above the lower corner of the scapula with the shoulder in 80 flexion. Pectoralis Major will be measured three-quarters of the way from the line between the sternum and the nodule prominence. Measurement of the Biceps Brachii and Brachioradialis muscles will be made from the most swollen points of the muscles. For measurement of the Flexor Carpi Radialis muscle, patients will be taken supine, with the forearm supinated and the elbow approximately 40 degrees flexed, at the one-third (approximately) point of the distance between the elbow line and the lateral side of the ulnar styloid. All measurements will be repeated 3 times and the average will be calculated. 6 minutes
Primary Box and Block Test It is a standardized assessment used to measure upper extremity motor dexterity. It involves moving blocks from one side of a box to the other within a minute. It is a clinic-friendly standardized assessment that is portable, easy to obtain, simple to administer, and can be administered quickly without a specific setting. 1 minute
Secondary Modified Ashworth Scale Upper extremity spasticity level of participants will be evaluated with the Modified Ashworth Scale (MAS). In the MAS evaluation, participants were in a supine position, with the arms next to the body and the shoulder in slight abduction. Shoulder adductors, elbow flexors and wrist flexors will be assessed. 3 minutes
Secondary Goniometer It will be used to measure the range of motion. Shoulder flexion and abduction, elbow extension, supination and pronation, and wrist extension, ulnar & radial deviation will be measured. 5 minutes
Secondary PhysioMaster This phone application will be used to measure the range of motion. Shoulder flexion and abduction, elbow extension, supination and pronation, and wrist extension, ulnar & radial deviation will be measured. 5 minutes
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