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OpenTrials
Completed

NCT Number: NCT01886144

Effects of Bracing on Knee Osteoarthritis (OA)

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stony Brook University; Rehabilitation Research and Movement Performance (RRAMP) Laboratory

Stony Brook, New York, 11794-8201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Knee OA Brace

Device

Other names: Rebel Reliever by Townsend Design

Primary outcomes

  1. Change in Knee Injury and Osteoarthritis Score (KOOS)

    Time frame: Baseline, 1 week, 2 week, 2 months, 3 months, 6 months

  2. Change in Adductory knee force during stair climbing

    Time frame: Baseline, 2 weeks, 2 months

Secondary outcomes

  1. Change in 6 Minute Walk Test

    Time frame: Baseline, 2 weeks, 2 months

  2. Change in Balance

    Time frame: Baseline, 2 weeks, 2 months

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Collaborators

  • Townsend Design

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
First posted
Jun 25, 2013
Registry last updated
May 12, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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