Effects of Bracing on Knee Osteoarthritis (OA)

May 9, 2014 updated by: Stony Brook University

Effectiveness of Decompressive and Stabilizing Knee Bracing in Individuals With Unicompartment Knee Osteoarthritis

Knee osteoarthritis (OA) is characterized by complaints of knee pain, aching and stiffness that commonly alter the way one will climb stairs and walk reducing an individual's function and the activities they may perform on a day-to-day basis. Providing a person with a knee brace designed for OA can help unload the arthritic part of the knee, thereby reducing pain and lead to improved function. The purpose of this study is to determine if use of the Rebel Reliever knee brace manufactured by Townsend Design can reduce pain and stiffness, improve strength and balance, and enhance functional activities such as stair and level gait, and ultimately lead to increased participation in the community.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Stony Brook, New York, United States, 11794-8201
        • Stony Brook University; Rehabilitation Research and Movement Performance (RRAMP) Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals who are currently living with Knee OA of one leg

Description

Inclusion Criteria:

  • Male or female
  • Aged between 35 and 70
  • Present with diagnosed unicompartment osteoarthritis of the knee

Exclusion Criteria:

  • Severe cardiac or pulmonary disease that limits ability to walk.
  • Presence of hip, ankle or foot OA or other lower limb pathology that limits ability to walk.
  • Bilateral knee OA
  • Previous use of an OA knee brace
  • Surgical procedure in either leg within the past 6-months
  • Anthropometrics that are incongruent with manufacturer's specifications for the Rebel Reliever

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Knee OA
People with knee OA of one knee
Device: Knee OA Brace
Other Names:
  • Rebel Reliever by Townsend Design

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Knee Injury and Osteoarthritis Score (KOOS)
Time Frame: Baseline, 1 week, 2 week, 2 months, 3 months, 6 months
Baseline, 1 week, 2 week, 2 months, 3 months, 6 months
Change in Adductory knee force during stair climbing
Time Frame: Baseline, 2 weeks, 2 months
Baseline, 2 weeks, 2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in 6 Minute Walk Test
Time Frame: Baseline, 2 weeks, 2 months
Baseline, 2 weeks, 2 months
Change in Balance
Time Frame: Baseline, 2 weeks, 2 months
Baseline, 2 weeks, 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stony Brook University

Collaborators

Townsend Design

Investigators

  • Principal Investigator: Eric Lamberg, EdD, PT, Stony Brook Univ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

May 1, 2014

Study Registration Dates

First Submitted

April 18, 2013

First Submitted That Met QC Criteria

June 21, 2013

First Posted (ESTIMATE)

June 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2014

Last Update Submitted That Met QC Criteria

May 9, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 402877

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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