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Comparing Pain and Kinematic Outcomes of Two Gait-Modifying Shoe Interventions

Study Purpose

This study involves the use of a newly designed shoe device for knee arthritis patients that may help reduce knee pain and improve function.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 45 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Chronic, OA-related knee pain - Diagnosis of medial compartment knee OA (unilateral or bilateral) - Moderate pain of ≥4 out of 10 points while performing a weight-bearing activity - Kellgren and Lawrence score of 2, 3, or 4 evidenced on routine, standard-of-care x-ray within the last 2 years prior to enrollment - Able to walk unassisted for at least 10 minutes at a time - Wear a Women's shoe size of 6.5 to 13 or a Men's shoe size of 5 to 12.

Exclusion Criteria:

  • - Patients suffering from acute septic or inflammatory arthritis - Unstable cardiovascular, orthopaedic, or neurological conditions, uncontrolled diabetes, or any condition that would preclude exercise in moderate duration, moderate workload trials - Received a corticosteroid injection or invasive procedures within prior 6 months of the study - History of avascular necrosis in the knee - History of knee buckling - Joint replacement in any lower extremity joint that has not optimally recovered (e.g. still causes significant pain or affects mobility) as determined by the PI.
- Experienced more than 3 falls within the last year - Currently using any knee brace on a regular basis for the knee pain, with the exception of basic knee sleeves - Pathological osteoporotic fracture - Severe symptomatic degenerative arthritis in lower limb joints other than the knees - Severe back pain, prior spinal fusion or spinal deformity that would affect gait - Major cardiac or pulmonary conditions and any orthopedic limitation that precludes their ability to independently walk for 10 minutes or longer - Knee flexion contracture greater than 15° - Knee flexion of less than 90° - Any major injury to either knee within the prior 12 months - Currently enrolled in a supervised physical therapy program

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03760380
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Florida
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Hari K Parvataneni
Principal Investigator Affiliation University of Florida
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Arthritis Knee
Additional Details

This study involves the use of a newly designed shoe device for knee arthritis patients that may help reduce knee pain and improve function. This is a 2-phase study designed to evaluate knee pain and function in healthy participants with a history of medial knee arthritis. The purpose of this study is to evaluate: 1. how using the shoe device will affect a person's walking gait and balance over a single day; and 2. how using the shoe device over the course of a 12-week period will affect a person's walking gait and balance.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Gainesville, Florida

Status

Recruiting

Address

UF & Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607

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