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NCT Number: NCT06813716

Acute Effects of Two Neoprene Knee Sleeves

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.

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Key information

Conditions

Knee Osteoarthristis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eskişehir Osmangazi University Department of Physical Medicine and Rehabilitation

Eskişehir, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Neoprene elastic knee sleeve

Other

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 supports

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Timed Up and Go (TUG)

    Time frame: Assessments were performed before and immediately after wearing the knee sleeves

    This test, which evaluates balance function is reported that a threshold value above 14 seconds predicts falls with high sensitivity and specificity.

  2. Functional Reach Test (FRT)

    Time frame: Assessments were performed before and immediately after wearing the knee sleeves

    15 cm or less indicates a significantly increased risk of falling, while 15 to 25 cm indicates a moderate risk of falling.

  3. Fall Index, calculated using posturography (Tetrax®)

    Time frame: Assessments were performed before and immediately after wearing the knee sleeves

    100 indicates the lowest risk of falling, while 0 indicates the highest risk of falling.

  4. the Visual Analog Scale (VAS)

    Time frame: Assessments were performed before and immediately after wearing the knee sleeves

    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.

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 7, 2025
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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