NCT05893706

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

June 6, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2023

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 13, 2024

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

7 days

First QC Date

May 30, 2023

Last Update Submit

November 14, 2025

Conditions

Keywords

dual task

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Dual task

A dual-task paradigm is a procedure in experimental neuropsychology that requires an individual to perform two tasks simultaneously, in order to compare performance with single-task conditions.

Single task

Single task

Eligibility Criteria

Age45 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A second assessment will be done 48 hours after the initial one. It will be completed as a dual job for the second evaluation. The patient will be given activities involving colors and numbers as part of the dual evaluation, and concurrently, after the isokinetic device has assessed the patient's muscle strength, the 30-second sit-and-stand test will assess the patient's function and balance.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol hospital

Istanbul, Istanbul Avrupa Kitasi, 34353, Turkey (Türkiye)

Location

Related 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.

    PMID: 32455597BACKGROUND

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 30, 2023

First Posted

June 8, 2023

Study Start

June 6, 2023

Primary Completion

June 13, 2023

Study Completion

May 13, 2024

Last Updated

November 17, 2025

Record last verified: 2025-11

Locations