Knee OsteoarthritisNCT06150170
Evaluation of the Efficiency of Propioceptive Study According to Radiological Stages in Patients With Knee Osteoarthritis
A study testing Proprioceptive training in people with Knee Osteoarthritis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Evaluation of the Efficiency of Propioceptive Study According to Radiological Stages in Patients with Knee Osteoarthritis Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Proprioceptive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Nov 2023to 5 Apr 2024
- Phase
- Interventional
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with knee osteoarthritis by a specialist physician using MRI, US or radiography and physical examination.
- Being between the ages of 35-70
- Stage 1-2-3-4 according to Kellegran Lawrence (K-L) in radiological examination
Who cannot join
- Having active synovitis
- Having received physical therapy in the last 6 months
- Those with neurological problems that affect walking
- Those with serious respiratory, central, peripheral, vascular and uncontrolled metabolic problems that will prevent exercise
- Has had lower extremity surgery in the past
- Intra-articular steroid injections within the last 6 months
Show all 9Show fewer
- Using psychoactive drugs
- Those with serious vision, hearing and speech disorders
- Patients with vestibular dysfunction will not be included in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Health Sciences University
Üsküdar, Istanbul, 34668
About this study
Evaluation of the Efficiency of Propioceptive Study According to Radiological Stages in Patients with Knee Osteoarthritis
Read the detailed description
Investigators divided patients with knee osteoarthritis into two groups. Group 1 consisted of stage 1 and stage 2 patients. Group 2 consisted of stage 3 and stage 4 patients. Proprioceptive training was applied in both groups. Investigators aim is to evaluate the effect of proprioceptive exercises on knee osteoarthritis according to the radiological level.
- Conditions
- Knee Osteoarthritis
- Being tested
- Proprioceptive training
- Keywords
- knee osteoarthritis, rehabilitation, exercise, physiotherapy, propioception
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive trainingOther
Proprioceptive exercises were applied to both groups. In addition to these exercises, balance, coordination and strengthening exercises will also be applied to both groups.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | This group includes patients with grade 1 and grade 2 knee osteoarthritis. Receives: Other: Proprioceptive training |
| Group 2 | Experimental | This group includes patients with grade 3 and grade 4 osteoarthritis. Receives: Other: Proprioceptive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The scale consists of 3 main headings and 24 questions. It is scored between 0 and 100. There is a negative correlation between scoring and functionality.
Measured: Evaluation will be performed before treatment and after 4 weeks rehabilitation program.
Secondary outcomes (9)
Visual Analogue Scale (VAS)
The levels of pain is felted at rest / activity / night will be measured using Visual Analogue Scale (VAS)..Patients will be asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain
Measured: Evaluation will be performed at Baseline (before treatment) and 4 weeks
Pressure Pain Threshold Measurement
A digital algometer will be used for Pressure Pain Threshold Measurement. Digital algometer is a device that objectively evaluates the pressure pain threshold. Low values indicate increased sensitivity and pain sensation.
Measured: Evaluation will be performed at Baseline (before treatment) and 4 weeks
Range of Motion (ROM)
Knee,food and hip ROM will be evaluated with digital goniometer while the patient will be in supine and prone position.
Measured: Evaluation will be performed at Baseline (before treatment) and 4 weeks
Timed Up and Go Test (TUG)
The scale consists of 7 questions measuring the physical activity of the individual in the last 7 days. The activity level is determined according to the scale score.
Measured: Evaluation will be performed at Baseline (before treatment) and 4 weeks
Manual Muscle Test
Manual Muscle Test is a procedure for the evaluation of strength of individual muscle or muscles group, based upon the effective performance of a movement in relation to the forces of gravity or manual resistance through the available ROM.
Measured: Evaluation will be performed at Baseline (before treatment) and 4 weeks
Short Form 36 (SF-36)
SF-36 will be used to assess physical and mental health-related quality of life. The total score is at least 0 and at most 100, and the high scores are positively correlated with high quality of life.
Measured: Evaluation will be performed at Baseline (before treatment) and 4 weeks
Global Rating of Change (GRC) Scale
Global Rating of Change (GRC) scale will be used to assess the overall satisfaction levels of the patients. Patients will be asked to evaluate their post-treatment status with a 5-point likert scale and high scores are positively correlated with satisfaction.
Measured: 4 weeks
International Physical Activity Scale (IPAQ)
The scale consists of 7 questions measuring the physical activity of the individual in the last 7 days. The activity level is determined according to the scale score.
Measured: Evaluation will be performed at Baseline (before treatment) and 4 weeks
Proprioception Sense
The sense of proprioception will be measured using a digital goniometer. It will be repeated 3 times. The average will be recorded
Measured: Evaluation will be performed at Baseline (before treatment) and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start21 Nov 2023
- Primary completion21 Dec 2023
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Gayretli Atan, Istanbul University
- Investigators
- Sibel Gayretli Atan, Principal investigator, sssibel_38@hotmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150170
- Sponsor's protocol ID
- SBU
- Status last verified
- Jul 2024
- First submitted
- 21 Nov 2023
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of Propioceptive Study According to Radiological Stages in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06150170
- Acronym / sponsor ID
- SBU
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, rehabilitation, exercise, physiotherapy, propioception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 29 Nov 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.
Evaluation of the Efficiency of Propioceptive Study According to Radiological Stages in Patients with Knee Osteoarthritis
Detailed description
Investigators divided patients with knee osteoarthritis into two groups. Group 1 consisted of stage 1 and stage 2 patients. Group 2 consisted of stage 3 and stage 4 patients. Proprioceptive training was applied in both groups. Investigators aim is to evaluate the effect of proprioceptive exercises on knee osteoarthritis according to the radiological level.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Proprioceptive trainingThis group includes patients with grade 1 and grade 2 knee osteoarthritis. |
| Group 2 | Experimental | Other: Proprioceptive trainingThis group includes patients with grade 3 and grade 4 osteoarthritis. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with knee osteoarthritis by a specialist physician using MRI, US or radiography and physical examination.
- Being between the ages of 35-70
- Stage 1-2-3-4 according to Kellegran Lawrence (K-L) in radiological examination
Key exclusion criteria (9 listed)
- Having active synovitis
- Having received physical therapy in the last 6 months
- Those with neurological problems that affect walking
- Those with serious respiratory, central, peripheral, vascular and uncontrolled metabolic problems that will prevent exercise
- Has had lower extremity surgery in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proprioceptive trainingProprioceptive exercises were applied to both groups. In addition to these exercises, balance, coordination and strengthening exercises will also be applied to both groups. | Other | Group 1, Group 2 |
Primary outcome
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: Evaluation will be performed before treatment and after 4 weeks rehabilitation program.
The scale consists of 3 main headings and 24 questions. It is scored between 0 and 100. There is a negative correlation between scoring and functionality.
9 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
Pressure Pain Threshold Measurement
Time frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
Range of Motion (ROM)
Time frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
Timed Up and Go Test (TUG)
Time frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
Manual Muscle Test
Time frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
Short Form 36 (SF-36)
Time frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
Global Rating of Change (GRC) Scale
Time frame: 4 weeks
International Physical Activity Scale (IPAQ)
Time frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
Proprioception Sense
Time frame: Evaluation will be performed at Baseline (before treatment) and 4 weeks
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 9 Jul 2024.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Sibel Gayretli Atan principal investigator
sssibel_38@hotmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive training in people with Knee Osteoarthritis, run by Istanbul University 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 3 inclusion and 9 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 9 Jul 2024. 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?
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) (time frame: Evaluation will be performed before treatment and after 4 weeks rehabilitation program.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2024.