Hemiplegic Shoulder PainNCT04292613
"The Effect of Hemiplegic Shoulder Pain on Balance, Upper Extremity Function and Quality of Life"
An observational study of Hemiplegic Shoulder Pain, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
"The Effect of Hemiplegic Shoulder Pain on Balance, Upper Extremity Function and Quality of Life" Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemiplegic Shoulder Pain
- What is being tested?
- "The Effect of Hemiplegic Shoulder Pain on Balance, Upper Extremity Function and Quality of Life"
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Mar 2020to 3 Aug 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: hemiplegic shoulder pain
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Therapy and Rehabilitation Training and Research Hospital
Bahçelievler, Istanbul, 34180
About this study
Official title: 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"
Read the 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.
- Conditions
- Hemiplegic Shoulder Pain
- Being tested
- "The Effect of Hemiplegic Shoulder Pain on Balance, Upper Extremity Function and Quality of Life"
- Keywords
- shoulder pain, hemiplegic, function, balance
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"The Effect of Hemiplegic Shoulder Pain on Balance, Upper Extremity Function and Quality of Life"Other
The Effect of Hemiplegic Shoulder Pain on Balance, Upper Extremity Function and Quality of Life"
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Extremite Fugl-Meyer Assessment (UA-FMA)
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.
Measured: 1 day (Evaluation will be done once)
Secondary outcomes (3)
McGill Melzack Pain Questionnaire
McGill Melzack Pain Questionnaire is used to assess pain. High scores are positively correlated with pain.
Measured: 1 day (Evaluation will be done once)
Short Form- 36
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.
Measured: 1 day (Evaluation will be done once)
Berg Balance Scale
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.
Measured: 1 day (Evaluation will be done once)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start5 Mar 2020
- Primary completion22 Jul 2020
- Study completion3 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic Shoulder PainStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Gayretli Atan, Istanbul University
- Investigators
- Sibel Gayretli Atan, Principal investigator, istanbul physical therapy and rehabilitation training and research hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292613
- Sponsor's protocol ID
- ''SBU''
- Status last verified
- Aug 2020
- First submitted
- 1 Mar 2020
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hemiplegic Shoulder Pain on Balance, Upper Extremity Function and Quality of Life"
- ClinicalTrials.gov ID
- NCT04292613
- Acronym / sponsor ID
- ''SBU''
- Conditions
- Hemiplegic Shoulder Pain
- Keywords
- shoulder pain, hemiplegic, function, balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 22 Jul 2020 (actual)
- Study completion
- 3 Aug 2020 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"The Effect of Hemiplegic Shoulder Pain on Balance, Upper Extremity Function and Quality of Life"
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- hemiplegic shoulder pain
Key inclusion criteria (6 listed)
- Having had a cerebrovascular accident
- Ages ranging from 40 to 75
- Right or left hemiplegic
- Without mental problems
- Cooperative
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "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" | Other | – |
Primary outcome
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.
3 secondary outcomes
McGill Melzack Pain Questionnaire
Time frame: 1 day (Evaluation will be done once)
Short Form- 36
Time frame: 1 day (Evaluation will be done once)
Berg Balance Scale
Time frame: 1 day (Evaluation will be done once)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sibel Gayretli Atan principal investigator
istanbul physical therapy and rehabilitation training and research hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemiplegic Shoulder Pain, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Extremite Fugl-Meyer Assessment (UA-FMA) (time frame: 1 day (Evaluation will be done once)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.