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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06391567
Other study ID # KAEU-T.ATAHAN-002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 10, 2023
Est. completion date April 16, 2024

Study information

Verified date April 2024
Source Kirsehir Ahi Evran Universitesi
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this study was to investigate the balance characteristics of patients with Frozen Shoulder.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date April 16, 2024
Est. primary completion date April 10, 2024
Accepts healthy volunteers
Gender All
Age group 40 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
There was no intervention in this study.
There was no intervention in this study.

Locations

Country Name City State
Turkey Atahan TURHAN Kirsehir Merkez

Sponsors (1)

Lead Sponsor Collaborator
Kirsehir Ahi Evran Universitesi

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sociodemographic Form 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
Primary Balance Function 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
Primary Static and Dynamic Postural Balance Biodex Balance System was used for objective assessment of static and dynamic postural balance. A high balance score indicates poor balance performance. 8 week
Primary Pain Intensity 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
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