- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06391567
Balance in People With Frozen Shoulder
April 25, 2024 updated by: Atahan TURHAN, Kirsehir Ahi Evran Universitesi
Determination of Balance Characteristics in People With Frozen Shoulders
The aim of this study was to investigate the balance characteristics of patients with Frozen Shoulder.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
86
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
-
-
Merkez
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Kirsehir, Merkez, Turkey, 40100
- Atahan TURHAN
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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
N/A
Sampling Method
Probability Sample
Study Population
Patients admitted to the Physical Medicine and Rehabilitation Outpatient Clinic with complaints of shoulder pain were examined by a physiatrist.
Patients who were diagnosed with Frozen Shoulder by physical examination, who met the inclusion criteria, and who agreed to participate in the study were included in the study.
The control group consisted of hospital and university staff.
The control group was also assessed by the same physiatrist and confirmed by the country's health database as having no chronic disease affecting balance.
Description
Inclusion Criteria:
- Volunteers aged 40-65 years,
- Diagnosed with unilateral Frozen Shoulder, Frozen Shoulder stage 2-3,
- Pain lasting more than 3 months,
- No mental or cognitive impairment
- At least 25% movement limitation in at least 2 movement planes and
- Able to cooperate.
Exclusion Criteria:
- Who had a neurological, rheumatic, cardiac and active malignant diseases
- Who had a history of surgery, trauma, and fracture
- Who had comorbid conditions that would affect balance
The control group consisted of healthy subjects who were not diagnosed with Frozen Shoulder and did not have a chronic disease that would affect balance between the ages of 40-65.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control Group
The control group consisted of healthy subjects who were not diagnosed with Frozen Shoulder and did not have a chronic disease that would affect balance between the ages of 40-65.
|
There was no intervention in this study.
|
Patient Group
Patients who were diagnosed with Frozen Shoulder by physical examination, met the inclusion criteria, and agreed to participate in the study were selected for the patient group.
|
There was no intervention in this study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sociodemographic Form
Time Frame: 8 week
|
Sociodemographic information of the patients included in the study, such as age, gender, height, weight, BMI, educational status, dominant side, comorbid status, and clinical information such as affected side, pain intensity, and pain duration were collected in a case report form by face-to-face interview
|
8 week
|
Balance Function
Time Frame: 8 week
|
Balance function was measured with the Timed Up and Go Test (TUG).
The TUG is a short, simple, and reliable test used to assess balance.
It shows that people who complete the test in less than 20 seconds are independent in transfers, while people who complete the test in 30 seconds or more are more dependent in activities of daily living.
|
8 week
|
Static and Dynamic Postural Balance
Time Frame: 8 week
|
Biodex Balance System was used for objective assessment of static and dynamic postural balance.
A high balance score indicates poor balance performance.
|
8 week
|
Pain Intensity
Time Frame: 8 week
|
The pain intensity of the patients was measured using the Visual Analogue Scale.
The pain intensity score ranges from 0 to 10.
An increase in the score indicates an increase in pain; a decrease in the score indicates a decrease in pain.
|
8 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
October 10, 2023
Primary Completion (Actual)
April 10, 2024
Study Completion (Actual)
April 16, 2024
Study Registration Dates
First Submitted
April 18, 2024
First Submitted That Met QC Criteria
April 25, 2024
First Posted (Actual)
April 30, 2024
Study Record Updates
Last Update Posted (Actual)
April 30, 2024
Last Update Submitted That Met QC Criteria
April 25, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAEU-T.ATAHAN-002
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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