Knee OsteoarthristisNCT06813716
Acute Effects of Two Neoprene Knee Sleeves
A study testing Neoprene elastic knee sleeve and Neoprene elastic knee sleeve with metal supports in people with Knee Osteoarthristis, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the immediate effects of two different types of elastic neoprene knee sleeves on balance and pain in patients with knee osteoarthritis (KOA). One knee sleeve was a standard elastic neoprene sleeve, while the other had four metal supports for additional stability. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Knee Osteoarthristis
- What is being tested?
- Neoprene elastic knee sleeve and Neoprene elastic knee sleeve with metal supports
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2022to 15 Oct 2023
- 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
- Radiographic knee osteoarthritis grade 2 (mild) or 3 (moderate) according to Kellgren-Lawrence scale,
- Knee muscle strength of 4 and above and those who voluntarily participated in the study
- Signed the informed consent form
Who cannot join
- Patients with arthroscopy of the knee joint within the last 1 year, knee and/or hip replacement,
- Limitation of joint range of motion,
- History of inflammatory rheumatic disease,
- History of vestibular and cerebellar disease,
- Visual loss of less than 2/10 in both eyes,
- History of diseases of the central and peripheral nervous system (Parkinson's disease, stroke, ataxia, dementia, multiple sclerosis, peripheral neuropath etc.)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskişehir Osmangazi University Department of Physical Medicine and Rehabilitation
Eskişehir
About this study
Official title: Comparison of the Acute Effects of Two Neoprene Knee Sleeves on Balance and Pain in Knee Osteoarthritis: A Randomized, Single-Blinded, Prospective Study
This study aimed to evaluate the immediate effects of two different types of elastic neoprene knee sleeves on balance and pain in patients with knee osteoarthritis (KOA). One knee sleeve was a standard elastic neoprene sleeve, while the other had four metal supports for additional stability.
In this randomized controlled study, 60 patients (50 females, 10 males) diagnosed with KOA were divided into two groups:
Read more
Group 1: Wore a standard elastic neoprene knee sleeve Group 2: Wore a neoprene knee sleeve with four metal supports
Each participant underwent clinical assessments before and after wearing the knee sleeve. The following tests were used:
Balance Assessments:
Berg Balance Scale (BBS): Measures overall balance ability. Timed Up and Go (TUG) Test: Evaluates mobility and fall risk. Functional Reach Test (FRT): Assesses stability by measuring how far a person can reach forward.
Fall Index (Tetrax® posturography): Provides an objective measure of fall risk.
Pain Assessment:
Visual Analog Scale (VAS): Measures the intensity of pain.
Further long-term studies are necessary to determine whether these immediate benefits persist over time.
Read the detailed description
KOA is a common joint disorder that leads to pain, stiffness, and impaired balance, increasing the risk of falls. Knee sleeves are often used as supportive devices to provide stability and reduce pain. However, there is limited evidence on their effectiveness in improving balance and reducing pain in KOA patients.
- Conditions
- Knee Osteoarthristis
- Being tested
- Neoprene elastic knee sleeve, Neoprene elastic knee sleeve with metal supports
- Keywords
- Balance, knee sleeve, osteoarthritis, posturography
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoprene elastic knee sleeveOther
We hypothesized that a neoprene elastic knee sleeve with metal supports would have a greater acute effect on balance and pain than a neoprene elastic sleeve. The first study to evaluate the acute effects of 2 different knee sleeves on pain and balance.
Neoprene elastic knee sleeve with metal supportsOther
We hypothesized that a neoprene elastic knee sleeve with metal supports would have a greater acute effect on balance and pain than a neoprene elastic sleeve. The first study to evaluate the acute effects of 2 different knee sleeves on pain and balance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : consisted of 30 patients wearing elastic neoprene knee sleeve | Active comparator | Not described Receives: Other: Neoprene elastic knee sleeve |
| group 2 consisted of 30 patients wearing neoprene knee sleeve with four metal supports | Active comparator | Not described Receives: Other: Neoprene elastic knee sleeve with metal supports |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Berg Balance Scale (BBS)
Total score is between 0-56. 56 points indicates perfect balance
Measured: Assessments were performed before and immediately after wearing the knee sleeves
Secondary outcomes (4)
Timed Up and Go (TUG)
This test, which evaluates balance function is reported that a threshold value above 14 seconds predicts falls with high sensitivity and specificity.
Measured: Assessments were performed before and immediately after wearing the knee sleeves
Functional Reach Test (FRT)
15 cm or less indicates a significantly increased risk of falling, while 15 to 25 cm indicates a moderate risk of falling.
Measured: Assessments were performed before and immediately after wearing the knee sleeves
Fall Index, calculated using posturography (Tetrax®)
100 indicates the lowest risk of falling, while 0 indicates the highest risk of falling.
Measured: Assessments were performed before and immediately after wearing the knee sleeves
the Visual Analog Scale (VAS)
Patients were required to indicate the level of pain they were experiencing on a scale of 0 to 10, with 0 representing no pain and 10 representing the most intense pain they had ever felt.
Measured: Assessments were performed before and immediately after wearing the knee sleeves
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start2 Dec 2022
- Primary completion15 Oct 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthristisStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulya Bakılan, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813716
- Sponsor's protocol ID
- ESOGUFtr1
- Status last verified
- Feb 2025
- First submitted
- 31 Jan 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Acute Effects of Two Neoprene Knee Sleeves on Balance and Pain in Knee Osteoarthritis: A Randomized, Single-Blinded, Prospective Study
- ClinicalTrials.gov ID
- NCT06813716
- Acronym / sponsor ID
- ESOGUFtr1
- Conditions
- Knee Osteoarthristis
- Keywords
- Balance, knee sleeve, osteoarthritis, posturography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 7 Feb 2025 (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.
This study aimed to evaluate the immediate effects of two different types of elastic neoprene knee sleeves on balance and pain in patients with knee osteoarthritis (KOA). One knee sleeve was a standard elastic neoprene sleeve, while the other had four metal supports for additional stability.
In this randomized controlled study, 60 patients (50 females, 10 males) diagnosed with KOA were divided into two groups:
Group 1: Wore a standard elastic neoprene knee sleeve Group 2: Wore a neoprene knee sleeve with four metal supports
Each participant underwent clinical assessments before and after wearing the knee sleeve. The following tests were used:
Balance Assessments:
Berg Balance Scale (BBS): Measures overall balance ability. Timed Up and Go (TUG) Test: Evaluates mobility and fall risk. Functional Reach Test (FRT): Assesses stability by measuring how far a person can reach forward.
Fall Index (Tetrax® posturography): Provides an objective measure of fall risk.
Pain Assessment:
Visual Analog Scale (VAS): Measures the intensity of pain.
Further long-term studies are necessary to determine whether these immediate benefits persist over time.
Detailed description
KOA is a common joint disorder that leads to pain, stiffness, and impaired balance, increasing the risk of falls. Knee sleeves are often used as supportive devices to provide stability and reduce pain. However, there is limited evidence on their effectiveness in improving balance and reducing pain in KOA patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 : consisted of 30 patients wearing elastic neoprene knee sleeve | Active comparator | Other: Neoprene elastic knee sleeve |
| group 2 consisted of 30 patients wearing neoprene knee sleeve with four metal supports | Active comparator | Other: Neoprene elastic knee sleeve with metal supports |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Radiographic knee osteoarthritis grade 2 (mild) or 3 (moderate) according to Kellgren-Lawrence scale,
- Knee muscle strength of 4 and above and those who voluntarily participated in the study
- Signed the informed consent form
Key exclusion criteria (6 listed)
- Patients with arthroscopy of the knee joint within the last 1 year, knee and/or hip replacement,
- Limitation of joint range of motion,
- History of inflammatory rheumatic disease,
- History of vestibular and cerebellar disease,
- Visual loss of less than 2/10 in both eyes,
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 |
|---|---|---|
| Neoprene elastic knee sleeveWe hypothesized that a neoprene elastic knee sleeve with metal supports would have a greater acute effect on balance and pain than a neoprene elastic sleeve. The first study to evaluate the acute effects of 2 different knee sleeves on pain and balance. | Other | Group 1 : consisted of 30 patients wearing elastic neoprene knee sleeve |
| Neoprene elastic knee sleeve with metal supportsWe hypothesized that a neoprene elastic knee sleeve with metal supports would have a greater acute effect on balance and pain than a neoprene elastic sleeve. The first study to evaluate the acute effects of 2 different knee sleeves on pain and balance. | Other | group 2 consisted of 30 patients wearing neoprene knee sleeve with four metal supports |
Primary outcome
The Berg Balance Scale (BBS)
Time frame: Assessments were performed before and immediately after wearing the knee sleeves
Total score is between 0-56. 56 points indicates perfect balance
4 secondary outcomes
Timed Up and Go (TUG)
Time frame: Assessments were performed before and immediately after wearing the knee sleeves
Functional Reach Test (FRT)
Time frame: Assessments were performed before and immediately after wearing the knee sleeves
Fall Index, calculated using posturography (Tetrax®)
Time frame: Assessments were performed before and immediately after wearing the knee sleeves
the Visual Analog Scale (VAS)
Time frame: Assessments were performed before and immediately after wearing the knee sleeves
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 18 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Neoprene elastic knee sleeve and Neoprene elastic knee sleeve with metal supports in people with Knee Osteoarthristis, run by Eskisehir Osmangazi 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 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 18 Feb 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?
The Berg Balance Scale (BBS) (time frame: Assessments were performed before and immediately after wearing the knee sleeves). 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 18 Feb 2025.