Acute Effects of Two Neoprene Knee Sleeves

NCT ID: NCT06813716

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-02
• Study Completion Date: 2023-10-15

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.

Conditions

Knee Osteoarthristis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Neoprene elastic knee sleeve

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Neoprene elastic knee sleeve with metal supports

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.)

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eskisehir Osmangazi University

OTHER

Sponsor Role: lead

Responsible Party

Fulya Bakılan

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eskişehir Osmangazi University Department of Physical Medicine and Rehabilitation

Eskişehir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ESOGUFtr1

Identifier Type: -

Identifier Source: org_study_id