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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05893706
Other study ID # E-10840098-772.02-3002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 10, 2023
Est. completion date February 13, 2024

Study information

Verified date February 2024
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Osteoarthritis is characterized by progressive degeneration of articular cartilage, weakening of subchondral bone, synovial inflammation, meniscal degeneration, and intra-articular osteophytes.


Description:

Dual tasking is when two tasks can be done simultaneously. A dual task may involve two different simultaneous motor tasks, or it may include a cognitive task in addition to the motor task. Following the additional task given, there may be a decrease in the performance of the main task or in the performance of both tasks. Decreased balance control can lead to fall injuries that result in serious physical, psychological and social losses. Before the management of this condition, an effective evaluation of balance control in patients with knee osteoarthritis is required.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 13, 2024
Est. primary completion date June 13, 2023
Accepts healthy volunteers No
Gender Female
Age group 45 Years to 65 Years
Eligibility Inclusion Criteria: - Being between the ages of 40-65 - A diagnosis of knee osteoarthritis in at least one of the knees clinically and radiographically according to the criteria of the American Society of Rheumatology - Findings consistent with stage II-III osteoarthritis - Pain is between 2 and 7 according to the visual analog scale. Exclusion Criteria: - Acute osteoarthritis in the knee - Comorbid diseases (advanced osteoporosis, vertigo, neurological diseases, etc.), injuries and surgeries for which exercise is contraindicated - NSAID and similar disease-modifying drug use (Diaserein, Glucosamine, etc.) - Having exercised regularly in the last 6 months (more than 1 day per week) - Having undergone arthroplasty surgery - Intra-articular injection (hyaluronic acid/steroid) administration in the last 6 months

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Medipol hospital Istanbul Istanbul Avrupa Kitasi

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Abdallat R, Sharouf F, Button K, Al-Amri M. Dual-Task Effects on Performance of Gait and Balance in People with Knee Pain: A Systematic Scoping Review. J Clin Med. 2020 May 21;9(5):1554. doi: 10.3390/jcm9051554. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Lower extremity muscle strength In the measurement of lower extremity muscle strength, Quadriceps and Hamstring muscle strength will be measured with an isokinetic dynamometer (CSMI-Cybex Humac-Norm Testing & Rehabilitation System). The knee extension test will be performed in a sitting position. The test foot will be secured with a Velcro strap by placing it on the dynamometer arm 1 inch above the ankle. The lateral epicondyle of the femur will be used as the anatomical reference with which the axis of the dynamometer is aligned. Two different speeds of maximal reciprocal concentric isokinetic knee extension and flexion; will be measured as slow (60°/s, 5 reps, 10 sec. rest) and fast (180°/s, 15 reps, 10 sec. rest) 3 days
Primary 30 second sit and stand test It is a functional evaluation test. It measures the time it takes to sit and stand in a 43-centimeter-high chair with back support but no armrests for 30 seconds. After the "Start" command, the participant must stand up fully, then return to the initial sitting position. The participant will be motivated to complete as many full sit-ups as possible within 30 seconds. The score is the total number of sits in 30 seconds. 3 days
Secondary Western Ontario and MacMaster The Western Ontario and MacMaster (WOMAC) questionnaire consists of a series of questions that assess three primary dimensions of osteoarthritis: pain, stiffness, and physical functionThe most commonly used scoring system for the WOMAC is the Likert scale, which ranges from 0 to 4 or 0 to 5 for each item.The maximum score would be 96 (the sum of the maximum scores from the three subscales). one day
Secondary Visual Analog Scale Visual Analogue Scale, pain level, right and left extremities were evaluated separately. In addition, three different measurements were taken as rest, activity and night. For individuals, a value of 0 was "no pain"; A value of 10 was defined as "unbearably severe pain". The point marked by the patient was measured with a tape measure, and the examined value was recorded. one day
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