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Acute Effects of Two Neoprene Knee Sleeves

Comparison of the Acute Effects of Two Neoprene Knee Sleeves on Balance and Pain in Knee Osteoarthritis: A Randomized, Single-Blinded, Prospective Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06813716
Enrollment
60
Registered
2025-02-07
Start date
2022-12-02
Completion date
2023-10-15
Last updated
2025-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthristis

Keywords

Balance, knee sleeve, osteoarthritis, posturography

Brief 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. 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.

Interventions

OTHERNeoprene elastic knee sleeve

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.

OTHERNeoprene elastic knee sleeve with metal supports

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.

Sponsors

Eskisehir Osmangazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.)

Design outcomes

Primary

MeasureTime frameDescription
The Berg Balance Scale (BBS)Assessments were performed before and immediately after wearing the knee sleevesTotal score is between 0-56. 56 points indicates perfect balance

Secondary

MeasureTime frameDescription
Timed Up and Go (TUG)Assessments were performed before and immediately after wearing the knee sleevesThis test, which evaluates balance function is reported that a threshold value above 14 seconds predicts falls with high sensitivity and specificity.
Functional Reach Test (FRT)Assessments were performed before and immediately after wearing the knee sleeves15 cm or less indicates a significantly increased risk of falling, while 15 to 25 cm indicates a moderate risk of falling.
Fall Index, calculated using posturography (Tetrax®)Assessments were performed before and immediately after wearing the knee sleeves100 indicates the lowest risk of falling, while 0 indicates the highest risk of falling.
the Visual Analog Scale (VAS)Assessments were performed before and immediately after wearing the knee sleevesPatients 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026