Clinical trial NCT06813716: Acute Effects of Two Neoprene Knee Sleeves
Official title: Comparison of the Acute Effects of Two Neoprene Knee Sleeves on Balance and Pain in Knee Osteoarthritis: A Randomized, Single-Blinded, Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthristis
Keywords: Balance, knee sleeve, osteoarthritis, posturography
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.)

Primary outcomes:
measure: The Berg Balance Scale (BBS)
timeFrame: Assessments were performed before and immediately after wearing the knee sleeves
Secondary outcomes:
measure: Timed Up and Go (TUG)
timeFrame: Assessments were performed before and immediately after wearing the knee sleeves
measure: Functional Reach Test (FRT)
timeFrame: Assessments were performed before and immediately after wearing the knee sleeves
measure: Fall Index, calculated using posturography (Tetrax®)
timeFrame: Assessments were performed before and immediately after wearing the knee sleeves
measure: the Visual Analog Scale (VAS)
timeFrame: Assessments were performed before and immediately after wearing the knee sleeves
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: Eskişehir Osmangazi University Department of Physical Medicine and Rehabilitation
Study officials:
References: