Acute Effects of Two Neoprene Knee Sleeves

NCT06813716 | Completed

• 1 other identifier: ESOGUFtr1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthristis

Keywords

Balance, knee sleeve, osteoarthritis, posturography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Timed Up and Go (TUG)

  Assessments were performed before and immediately after wearing the knee sleeves

• Functional Reach Test (FRT)

  Assessments were performed before and immediately after wearing the knee sleeves

• Fall Index, calculated using posturography (Tetrax®)

  Assessments were performed before and immediately after wearing the knee sleeves

• the Visual Analog Scale (VAS)

  Assessments were performed before and immediately after wearing the knee sleeves

Study Arms (2)

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

Interventions

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.

Group 1 : consisted of 30 patients wearing elastic neoprene knee sleeve

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.

group 2 consisted of 30 patients wearing neoprene knee sleeve with four metal supports

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskişehir Osmangazi University Department of Physical Medicine and Rehabilitation

Eskişehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 7, 2025
• Study Start: December 2, 2022
• Primary Completion: October 15, 2023
• Study Completion: October 15, 2023
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

TU (1)