- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04292613
"The Effect of Hemiplegic Shoulder Pain on Balance, Upper Extremity Function and Quality of Life"
August 3, 2020 updated by: Sibel Gayretli Atan, Istanbul University
The Effect of Hemiplegic Shoulder Pain on Balance, Upper Extremity Function and Quality of Life"
"The Effect of Hemiplegic Shoulder Pain on Balance, Upper Extremity Function and Quality of Life"
Study Overview
Status
Completed
Conditions
Detailed Description
Hemiplegic shoulder pain is a common symptom.
Our aim in this study is to investigate the relationship between hemiplegic shoulder pain and balance and upper extremity functions.
Study Type
Observational
Enrollment (Actual)
48
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Istanbul
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Bahçelievler, Istanbul, Turkey, 34180
- Istanbul Physical Therapy and Rehabilitation Training and Research Hospital
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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
40 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
hemiplegic shoulder pain
Description
Inclusion Criteria:
- Having had a cerebrovascular accident
- Ages ranging from 40 to 75
- Right or left hemiplegic
- Without mental problems
- Cooperative
- According to Brunnstrom staging, upper extremity stage 1-2-3-4-5
Exclusion Criteria:
- who do not want to be evaluated
- Under the age of 40 and over the age of 75
- Non-cooperative
- Another orthopedic shoulder problem
- Newly operated patients will not be included in the study.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Upper Extremite Fugl-Meyer Assessment (UA-FMA)
Time Frame: 1 day (Evaluation will be done once)
|
Upper Extremite Fugl-Meyer Assessment (UA-FMA) is a scale that evaluates upper extremity functionality.
The total score is at least 0 and at most 66 and the high scores are positively correlated with the normal function.
|
1 day (Evaluation will be done once)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
McGill Melzack Pain Questionnaire
Time Frame: 1 day (Evaluation will be done once)
|
McGill Melzack Pain Questionnaire is used to assess pain.
High scores are positively correlated with pain.
|
1 day (Evaluation will be done once)
|
Short Form- 36
Time Frame: 1 day (Evaluation will be done once)
|
SF-36 will be used to assess physical and mental health-related quality of life.
The total score is at least 0 and at most 100, and the high scores are positively correlated with high quality of life.
|
1 day (Evaluation will be done once)
|
Berg Balance Scale
Time Frame: 1 day (Evaluation will be done once)
|
Berg balance scale is a scale used to evaluate balance.The total score is at least 0 and at most 56, and the high scores are negatively correlated with high quality of life.
|
1 day (Evaluation will be done once)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sibel Gayretli Atan, Istanbul Physical Therapy and Rehabilitation Training and Research Hospital
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 5, 2020
Primary Completion (ACTUAL)
July 22, 2020
Study Completion (ACTUAL)
August 3, 2020
Study Registration Dates
First Submitted
March 1, 2020
First Submitted That Met QC Criteria
March 2, 2020
First Posted (ACTUAL)
March 3, 2020
Study Record Updates
Last Update Posted (ACTUAL)
August 4, 2020
Last Update Submitted That Met QC Criteria
August 3, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ''SBU''
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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