- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06272175
Immediate Effects of Open and Closed Kinetic Chain Exercises on Upper Extremity in Stroke Patients.
March 5, 2024 updated by: Çiçek Günday, Istinye University
Immediate Effects of Open and Closed Kinetic Chain Activities on Upper Extremity Spasticity and Motor Dexterity in Stroke Patients"
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Çiçek GÜNDAY, PhD(c)
- Phone Number: +90 507 188 8848
- Email: cckdmn@gmail.com
Study Locations
-
-
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Istanbul, Turkey
- Recruiting
- Istinye University Hospital Medical Park Gaziosmanpasa
-
Contact:
- Mehmet Salih Baran, Assist. Prof.
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Open Kinetic Chain Activity Group
Open kinetic chain activity will involve Flexion-Abduction-External Rotation and Flexion-Adduction-External Rotation patterns from the Proprioceptive Neuromuscular Facilitation (PNF).
During the application, participants will lie on their back, and the pattern will be initiated from the opposite direction of the targeted movement.
Participants will be encouraged to perform the movement as actively as possible.
Assistance will be provided if the participant cannot complete the pattern.
No other PNF techniques will be applied.
Both patterns will be practiced for 10 repetitions.
Resting periods will be provided as needed to prevent fatigue.
The entire application is planned to last approximately 5 minutes.
|
PNF Flexion-Abduction-External Rotation and Flexion-Adduction-External Rotation patterns will be actively performed on the hemiplegic upper extremity.
|
Experimental: Closed Kinetic Chain Activity Group
For closed kinetic chain activity of the upper extremity, an activity involving weight shifting onto the hands on a table while standing with the elbows in extension will be used.
Participants will be asked to shift weight onto the hemiplegic upper extremity for 30 seconds.
After a 30-second rest period, the weight shifting will be repeated for a second time.
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Weight-bearing on the hemiplegic hand with extended elbow in standing position
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MyotonPRO digital palpation device
Time Frame: 6 minutes
|
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.
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6 minutes
|
Box and Block Test
Time Frame: 1 minute
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Ashworth Scale
Time Frame: 3 minutes
|
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.
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3 minutes
|
Goniometer
Time Frame: 5 minutes
|
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
|
PhysioMaster
Time Frame: 5 minutes
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Merve Can, Istinye University
- Study Chair: Seyhan Söyüncü, Istinye University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 4, 2024
Primary Completion (Estimated)
September 30, 2024
Study Completion (Estimated)
December 30, 2024
Study Registration Dates
First Submitted
February 15, 2024
First Submitted That Met QC Criteria
February 15, 2024
First Posted (Actual)
February 22, 2024
Study Record Updates
Last Update Posted (Actual)
March 7, 2024
Last Update Submitted That Met QC Criteria
March 5, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10102023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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