Osteo Arthritis KneeNCT03893981
Strengthening Exercises Versus Proprioception and Balance Exercises in the Treatment of Knee Osteoarthritis
A study testing Proprioception and Balance Program and Strengthening Program in people with Osteo Arthritis Knee and Pain, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to investigate and compare the effect of balance and proprioception exercises with strengthening exercises on muscle strength, pain, proprioception, function and quality of life in knee osteoarthritis patients. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Osteo Arthritis Knee, Pain
- What is being tested?
- Proprioception and Balance Program and Strengthening Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jul 2019to 11 Aug 2020
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have a diagnosis of knee Osteoarthritis according to the American Society of Rheumatology (ACR) criteria,
- Between 45 to 75 years of age
- Can read and write in Turkish language
Who cannot join
- Active synovitis
- Taking any physical therapy section in the last 6 months
- Have a neurological problems that affect walking
- Have an arthritis problem in the ankle and hip joint
- Have a history of lower extremity surgery
- Intraarticular steroid injection in the last 6 months
Show all 9Show fewer
- Use psychoactive drug
- Have a severe defect of vision and hearing, speech disorders
- Vestibular dysfunction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa, Faculty Of Health Sciences
Istanbul, Bakirkoy, 34147
About this study
Official title: Comparison of the Effect of Strengthening Exercises Versus Proprioception and Balance Exercises in the Treatment of Knee Osteoarthritis
The aim of the study is to investigate and compare the effect of balance and proprioception exercises with strengthening exercises on muscle strength, pain, proprioception, function and quality of life in knee osteoarthritis patients.
Read the detailed description
Damage or loss of mechanoreceptors in osteoarthritis patients affects balance and proprioception. There are studies showing that proprioceptive deficit is associated with the onset and progression of knee osteoarthritis leading to pain and disability. Because the proprioception provides a sense of power generation and allows the power output to be better regulated. When the literature is examined, studies investigating the effects of proprioception and balance exercises on muscle strength, function and pain are limited.
In our study patients will be randomly divided into two groups: Group I (Proprioception and Balance) and Group II (muscle strengthening exercises). While Group I will be applied Proprioception and Balance training exercises, Group II will be applied closed and open kinetic strengthening exercises. Two group will perform exercise 3 times a week during 8 weeks.
- Conditions
- Osteo Arthritis Knee, Pain
- Being tested
- Proprioception and Balance Program, Strengthening Program
- Keywords
- Rehabilitation, Pain, Functionality, Proprioception
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioception and Balance ProgramOther
Balance Trainer device and playing ball in tandem position for using to improve balance, vibration and reposition exercises for using to improve proprioception. Progressive of training will increase after each 2 weeks.Patients will be taken to the treatment program 3 days in a week for 8 weeks.
Strengthening ProgramOther
Exercises which include open and closed kinetic chain exercise will be applied to strength knee and hip muscle. Progressive of training will increase after each 2 weeks. Patients will be taken to the treatment program 3 days in a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Proprioception and Balance Training | Experimental | Proprioception and Balance Program Receives: Other: Proprioception and Balance Program |
| Strengthening Training | Experimental | Strengthening Program Receives: Other: Strengthening Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The WOMAC is widely used self-administered health status measure used in assessing pain, stiffness and function in patients with OA of the knee or hip. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).
The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: WOMAC will be filled first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program . After treatment "change" will be assessed
Secondary outcomes (10)
Visual Analogue Scale (VAS)
The Visual Analog Scale (VAS) is a 10 cm line with anchor statements on the left (no pain) and on the right (extreme pain). The patient is asked to place a vertical mark on the scale to indicate the level of intensity of his or her pain.
Measured: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Pressure Algometer
Pressure algometry is one of a number of outcome measures that manual therapy practitioners are able to use in both clinical and research settings. The pressure algometer is used to determine the pressure pain threshold of specific muscle and bone locations.
Measured: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Hand-Held Dynamometer
Handheld dynamometers are one of the most objective and consistent tools to use when muscle testing. It is an ergonomic hand-held device for objectively quantifying muscle strength.
Measured: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Isokinetic Dynamometer for measuring position sense
Isokinetic dynamometer is a well known device to measure active and passive JPS and also provides target angle result without any researcher bias/It has shown good reliability and validity for measuring position sense.
Measured: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Short Form-36
The Short Form (36) Health Survey is a 36-item, patient-reported survey of health related quality of life. The RAND 36-Item Health Survey taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health.
Measured: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Global Rating of Change Scale
Global rating of change (GRC) scales are very commonly used in clinical research, particularly in the musculo-skeletal area These scales are designed to quantify a patient's improvement or deterioration over time, usually either to determine the effect of an intervention or to chart the clinical course of a condition. Global Rating of Change Scale will be used to evaluate patients' satisfaction from treatment.
Measured: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Aggregated Locomotor Function (ALF) Score
The aggregated locomotor function (ALF) score, a simple measure of observed locomotor function, using timed walking, stairs and transfers, was developed and evaluated for intra-tester reliability, criterion-related validity and responsiveness in a sample of patients with knee osteoarthritis.
Measured: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Digital Goniometer
Digital Goniometer is a tool used most commonly for evaluating joint ROM in the clinical settings. Also it is a simple alternative for global use.
Measured: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Timed Up and Go (TUG) Test
Timed Up and Go (TUG) Test will be used clinical performance-based measure of lower extremity function, mobility and fall risk.
Measured: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Tandem and Stand on One Leg
Tandem and Stand on One Leg will ve used to assesment of static balance of patients
Measured: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start16 Jul 2019
- Primary completion11 Aug 2020
- Study completion11 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Kus, Istanbul University
- Investigators
- Gamze Kuş, MsC, Principal investigator, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893981
- Sponsor's protocol ID
- 99984023-302.99
- Status last verified
- Aug 2020
- First submitted
- 7 Mar 2019
- Last updated
- 12 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Strengthening Exercises Versus Proprioception and Balance Exercises in the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03893981
- Acronym / sponsor ID
- 99984023-302.99
- Conditions
- Osteo Arthritis Knee, Pain
- Keywords
- Rehabilitation, Pain, Functionality, Proprioception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 11 Aug 2020 (actual)
- Study completion
- 11 Aug 2020 (actual)
- First posted
- 28 Mar 2019 (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.
The aim of the study is to investigate and compare the effect of balance and proprioception exercises with strengthening exercises on muscle strength, pain, proprioception, function and quality of life in knee osteoarthritis patients.
Detailed description
Damage or loss of mechanoreceptors in osteoarthritis patients affects balance and proprioception. There are studies showing that proprioceptive deficit is associated with the onset and progression of knee osteoarthritis leading to pain and disability. Because the proprioception provides a sense of power generation and allows the power output to be better regulated. When the literature is examined, studies investigating the effects of proprioception and balance exercises on muscle strength, function and pain are limited.
In our study patients will be randomly divided into two groups: Group I (Proprioception and Balance) and Group II (muscle strengthening exercises). While Group I will be applied Proprioception and Balance training exercises, Group II will be applied closed and open kinetic strengthening exercises. Two group will perform exercise 3 times a week during 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proprioception and Balance Training | Experimental | Other: Proprioception and Balance ProgramProprioception and Balance Program |
| Strengthening Training | Experimental | Other: Strengthening ProgramStrengthening Program |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have a diagnosis of knee Osteoarthritis according to the American Society of Rheumatology (ACR) criteria,
- Between 45 to 75 years of age
- Can read and write in Turkish language
Key exclusion criteria (9 listed)
- Active synovitis
- Taking any physical therapy section in the last 6 months
- Have a neurological problems that affect walking
- Have an arthritis problem in the ankle and hip joint
- Have a history of lower extremity surgery
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 |
|---|---|---|
| Proprioception and Balance ProgramBalance Trainer device and playing ball in tandem position for using to improve balance, vibration and reposition exercises for using to improve proprioception. Progressive of training will increase after each 2 weeks.Patients will be taken to the treatment program 3 days in a week for 8 weeks. | Other | Proprioception and Balance Training |
| Strengthening ProgramExercises which include open and closed kinetic chain exercise will be applied to strength knee and hip muscle. Progressive of training will increase after each 2 weeks. Patients will be taken to the treatment program 3 days in a week for 8 weeks. | Other | Strengthening Training |
Primary outcome
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: WOMAC will be filled first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program . After treatment "change" will be assessed
The WOMAC is widely used self-administered health status measure used in assessing pain, stiffness and function in patients with OA of the knee or hip. The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
10 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Pressure Algometer
Time frame: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Hand-Held Dynamometer
Time frame: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Isokinetic Dynamometer for measuring position sense
Time frame: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Short Form-36
Time frame: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Global Rating of Change Scale
Time frame: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Aggregated Locomotor Function (ALF) Score
Time frame: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Digital Goniometer
Time frame: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Timed Up and Go (TUG) Test
Time frame: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
Tandem and Stand on One Leg
Time frame: Evaluation will perform first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program.
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 12 Aug 2020.
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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.
Gamze Kuş, MsC principal investigator
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioception and Balance Program and Strengthening Program in people with Osteo Arthritis Knee and Pain, 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 12 Aug 2020. 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?
Western Ontario and McMaster Universities Arthritis Index (WOMAC) (time frame: WOMAC will be filled first time at baseline and second time after 4 weeks and third time after 8 weeks rehabilitation program . After treatment "change" will be assessed). 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 12 Aug 2020.