Effects of Bracing on Knee Osteoarthritis (OA)

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01886144
• Other study ID #: 402877
• Status: Completed
• Phase: N/A
• First received: April 18, 2013
• Last updated: May 9, 2014
• Start date: July 2013

Study information

• Verified date: May 2014
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 70 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Knee OA Brace

Locations

Country	Name	City	State
United States	Stony Brook University; Rehabilitation Research and Movement Performance (RRAMP) Laboratory	Stony Brook	New York

Sponsors (2)

Lead Sponsor	Collaborator
Stony Brook University	Townsend Design

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Knee Injury and Osteoarthritis Score (KOOS)		Baseline, 1 week, 2 week, 2 months, 3 months, 6 months	No
Primary	Change in Adductory knee force during stair climbing		Baseline, 2 weeks, 2 months	No
Secondary	Change in 6 Minute Walk Test		Baseline, 2 weeks, 2 months	No
Secondary	Change in Balance		Baseline, 2 weeks, 2 months	No