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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthristis
• Intervention / Treatment: Other: Neoprene elastic knee sleeve; Other: Neoprene elastic knee sleeve with metal supports

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Eskisehir, Turkey
    • Eskişehir Osmangazi University Department of Physical Medicine and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 : consisted of 30 patients wearing elastic neoprene knee sleeve	Other: Neoprene 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.
Active Comparator: group 2 consisted of 30 patients wearing neoprene knee sleeve with four metal supports	Other: Neoprene 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Berg Balance Scale (BBS)	Total score is between 0-56. 56 points indicates perfect balance	Assessments were performed before and immediately after wearing the knee sleeves

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Assessments were performed before and immediately after wearing the knee sleeves

Collaborators and Investigators

• Sponsor: Eskisehir Osmangazi University

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2022
• Primary Completion (Actual): October 15, 2023
• Study Completion (Actual): October 15, 2023

Study Registration Dates

• First Submitted: January 31, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Balance, knee sleeve, osteoarthritis, posturography
• Other Study ID Numbers: ESOGUFtr1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No