Knee OsteoarthritisNCT01886144
Effects of Bracing on Knee Osteoarthritis (OA)
An observational study of Knee Osteoarthritis, run by Stony Brook University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Knee OA Brace
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to May 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals who are currently living with Knee OA of one leg
Who may be able to join
- Male or female
- Aged between 35 and 70
- Present with diagnosed unicompartment osteoarthritis of the knee
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University; Rehabilitation Research and Movement Performance (RRAMP) Laboratory
Stony Brook, New York, 11794-8201
About this study
Official title: 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Knee OA Brace
- Keywords
- OA, arthritis, knee OA
- Medical subject headings
- Osteoarthritis, Knee, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee OA BraceDevice
Also called Rebel Reliever by Townsend Design
| Study group | Role | What they receive |
|---|---|---|
| Knee OA | People with knee OA of one knee Receives: Device: Knee OA Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee Injury and Osteoarthritis Score (KOOS)
Measured: Baseline, 1 week, 2 week, 2 months, 3 months, 6 months
Change in Adductory knee force during stair climbing
Measured: Baseline, 2 weeks, 2 months
Secondary outcomes (2)
Change in 6 Minute Walk Test
Measured: Baseline, 2 weeks, 2 months
Change in Balance
Measured: Baseline, 2 weeks, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Townsend Design
- Responsible party
- Sponsor
- Investigators
- Eric Lamberg, EdD, PT, Principal investigator, Stony Brook Univ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886144
- Sponsor's protocol ID
- 402877
- Status last verified
- May 2014
- First submitted
- 18 Apr 2013
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Decompressive and Stabilizing Knee Bracing in Individuals With Unicompartment Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT01886144
- Acronym / sponsor ID
- 402877
- Conditions
- Knee Osteoarthritis
- Keywords
- OA, arthritis, knee OA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Townsend Design
- Study start
- Jul 2013
- Primary completion
- May 2014 (actual)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee OA | – | Device: Knee OA BracePeople with knee OA of one knee |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who are currently living with Knee OA of one leg
Key inclusion criteria (3 listed)
- Male or female
- Aged between 35 and 70
- Present with diagnosed unicompartment osteoarthritis of the knee
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knee OA BraceAlso: Rebel Reliever by Townsend Design | Device | Knee OA |
Primary outcome
Change in Knee Injury and Osteoarthritis Score (KOOS)
Time frame: 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
2 secondary outcomes
Change in 6 Minute Walk Test
Time frame: Baseline, 2 weeks, 2 months
Change in Balance
Time frame: Baseline, 2 weeks, 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Lamberg, EdD, PT principal investigator
Stony Brook Univ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee Injury and Osteoarthritis Score (KOOS) (time frame: Baseline, 1 week, 2 week, 2 months, 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2014.