Osteo Arthritis KneeNCT05893706
The Effect of Single Task vs. Dual Task Assessment in Individuals With Knee Osteoarthritis
An observational study of Osteo Arthritis Knee, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Osteoarthritis is characterized by progressive degeneration of articular cartilage, weakening of subchondral bone, synovial inflammation, meniscal degeneration, and intra-articular osteophytes. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Osteo Arthritis Knee
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2023to 13 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Medipol hospital
Istanbul, Istanbul Avrupa Kitasi, 34353
About this study
Official title: The Effect of Single Task vs. Dual Task Assessment on Muscle Strength and Performance in Individuals With Knee Osteoarthritis
Osteoarthritis is characterized by progressive degeneration of articular cartilage, weakening of subchondral bone, synovial inflammation, meniscal degeneration, and intra-articular osteophytes.
Read the detailed 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.
- Conditions
- Osteo Arthritis Knee
- Keywords
- dual task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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).
Measured: 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.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start6 Jun 2023
- Primary completion13 Jun 2023
- Study completion13 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Istanbul Medipol University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hazal genc, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893706
- Sponsor's protocol ID
- E-10840098-772.02-3002
- Status last verified
- Nov 2025
- First submitted
- 30 May 2023
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32455597
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Single Task vs. Dual Task Assessment on Muscle Strength and Performance in Individuals With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05893706
- Acronym / sponsor ID
- E-10840098-772.02-3002
- Conditions
- Osteo Arthritis Knee
- Keywords
- dual task
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 13 Jun 2023 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoarthritis is characterized by progressive degeneration of articular cartilage, weakening of subchondral bone, synovial inflammation, meniscal degeneration, and intra-articular osteophytes.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lower extremity muscle strength
Time frame: 3 days
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)
30 second sit and stand test
Time frame: 3 days
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.
Western Ontario and MacMaster
Time frame: one day
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).
Visual Analog Scale
Time frame: one day
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Background: PubMed 32455597Abdallat 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteo Arthritis Knee, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower extremity muscle strength (time frame: 3 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05893706, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.