Effects of Bracing on Knee Osteoarthritis (OA) | NCT01886144

Studies
Effects of Bracing on Knee Osteoarthritis (OA)

NCT01886144

Sponsor

Stony Brook University

Status

Completed

Last Update Posted

May 12, 2014Estimated

Enrollment

25Estimated

Phase

Not provided

Conditions

Knee Osteoarthritis

Interventions

Knee OA Brace

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

May 2014Actual

Completion Date

Not provided

First Submitted Date

Apr 18, 2013

First Submission Date that Met QC Criteria

Jun 21, 2013

First Posted Date

Jun 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2014

Last Update Posted Date

May 12, 2014Estimated

Name	Class
Townsend Design	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Knee OA		People with knee OA of one knee	Device: Knee OA Brace

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Knee OA Brace	Device		Knee OA	Rebel Reliever by Townsend Design

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Individuals who are currently living with Knee OA of one leg

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eric Lamberg, EdD, PT	Stony Brook Univ	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stony Brook University; Rehabilitation Research and Movement Performance (RRAMP) Laboratory		Stony Brook	New York	11794-8201	United States

Condition Browse Module

MeSH Terms

ID	Term
D020370	Osteoarthritis, Knee
D001168	Arthritis

Ancestor Terms

ID	Term
D010003	Osteoarthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided