NCT01886144

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Last Updated

May 12, 2014

Status Verified

May 1, 2014

Enrollment Period

10 months

First QC Date

April 18, 2013

Last Update Submit

May 9, 2014

Conditions

Knee Osteoarthritis

Keywords

OAarthritisknee OA

Outcome Measures

Primary Outcomes (2)

  • Change in Knee Injury and Osteoarthritis Score (KOOS)

    Baseline, 1 week, 2 week, 2 months, 3 months, 6 months

  • Change in Adductory knee force during stair climbing

    Baseline, 2 weeks, 2 months

Secondary Outcomes (2)

  • Change in 6 Minute Walk Test

    Baseline, 2 weeks, 2 months

  • Change in Balance

    Baseline, 2 weeks, 2 months

Study Arms (1)

Knee OA

People with knee OA of one knee

Device: Knee OA Brace

Interventions

Knee OA BraceDEVICE
Also known as: Rebel Reliever by Townsend Design
Knee OA

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals who are currently living with Knee OA of one leg

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

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

Location

MeSH Terms

Conditions

Osteoarthritis, KneeArthritis

Condition Hierarchy (Ancestors)

OsteoarthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Eric Lamberg, EdD, PT

    Stony Brook Univ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2013

First Posted

June 25, 2013

Study Start

July 1, 2013

Primary Completion

May 1, 2014

Last Updated

May 12, 2014

Record last verified: 2014-05

Locations

US(1)