- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05828706
The Effects of Pain and Disability Resulting From Shoulder Pathologies On Balance and Mobility
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
İstanbul, Turkey, 347093
- Prof. Dr. Bezmialem Vakif University Faculty of Medicine, Department of Physical Medicine and Rehabilitation.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Our study was carried out by Prof. Dr. Bezmialem Vakif University Faculty of Medicine, Department of Physical Medicine and Rehabilitation. Dr. It is planned to include patients referred by Teoman Aydın. In our study, post-hoc power analysis was performed and it was determined that 36 individuals were needed to achieve 95% power with an effect size of r:0.50. Considering the possibility of cases dropping out of the study, it is planned to include 40 individuals.
Sociodemographic information form, Shoulder Pain and Disability Index (SPADI), One-leg standing test, 5 sit and stand test, TINetti balance and walking test will be evaluated for the included patients.
Description
Inclusion Criteria:
- Having a pathology related to the upper extremity shoulder such as Impingement, Rotator cuff tear or repair, Adhesive capsulitis (frozen shoulder),
- Able to communicate
- Individuals between the ages of 40-65 who agreed to participate in the study
Exclusion Criteria:
- Having vision and hearing problems
- Having other accompanying neurological, psychiatric and/or orthopedic problems other than shoulder pathologies
- Having a pregnancy status
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of Shoulder Pain and Functionality (SPADI)
Time Frame: 10 minutes
|
SPADI includes 5 questions about pain and 8 questions about disability, and patients are asked to answer these questions on a numerical scale (22).
The score is calculated for pain and disability separately and together.
While calculating the score, the sum of the points given to the questions in each section is divided by the maximum score that can be obtained from that section and multiplied by 100.
Similarly, in the total score, the total score of all questions is divided by 130 and multiplied by 100.
Thus, the scores obtained as a percentage range from 0 to 100.
|
10 minutes
|
One Leg Stance Test
Time Frame: 10 minutes
|
The one-leg stance test is a test that measures the time of standing on the right and left extremities of the patient and evaluates the static balance.
Evaluation is made by recording the time from the moment the patient starts to stand on one leg to the first moment when postural stability is impaired (25).
It gives an idea about an individual's risk of falling.
If he can stand on one leg for 30 seconds, it can be said that the test is over.
If the cut-off value is <10 seconds, it means "unbalance", and if it is <5 seconds, it means "there is a risk of falling" (26).
|
10 minutes
|
5 Repetition Sit and Stand Test
Time Frame: 10 minutes
|
It is a performance test that evaluates the functional strength of the lower extremity, transitional movements, fall risk, and dynamic balance by recording the performance of individuals sitting and standing on a chair 5 times in series (27).
Whitney et al.
Developed by The patient is asked to quickly stand up and sit down from the standard chair in which he sits with his arms crossed over his shoulders and his back leaning against the chair (28).
Norm times according to age are '60-69' 11.4 seconds, '70-79' 12.6 seconds, and '80-89' 14.8 seconds.
The periods indicating the presence of risk of falling are 'Old >12 sec.
(If >15 repetitive), Vestibular disease >15 sec., Parkinson's >16 sec' (29).
|
10 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Biruni Univ
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Shoulder Injuries
-
University of FloridaMajor League BaseballCompletedShoulder Injuries | Shoulder Flexibility | Rotational Resistance of ShoulderUnited States
-
Schulthess KlinikCompletedShoulder Injuries and DisordersSwitzerland
-
Encore Research Inc.CoolSystems, Inc.Completed
-
University of North Carolina, Chapel HillCompleted
-
University GhentCompletedRisk Factors for Shoulder InjuriesNetherlands
-
Asklepieion Voulas General HospitalAretaieion University HospitalCompletedRotator Cuff Injury | Shoulder Arthritis | Shoulder Dislocation | Shoulder FractureGreece
-
Schulthess KlinikWithdrawn
-
Istituto Nazionale Assicurazione contro gli Infortuni...Istituto Italiano di TecnologiaCompletedShoulder Injuries and DisordersItaly
-
University of ChileCompleted
-
Panam ClinicRecruitingAnterior Shoulder Instability | Anterior Shoulder DislocationCanada