Purpose

AposTherapy is a home based exercise program utilizing footwear that causes exercise with normal activity that may significantly improve function in patients with knee osteoarthritis since patients with knee osteoarthritis have altered mechanics of motion contributing or due to the presence of the conditions. Capitalizing on the reported excellent adherence and clinical benefit of ApostTherapy in patients with significant knee OA, the investigators propose to evaluate this as a conservative treatment that may supplant/supplement traditional pain medications and physical therapy in an at-risk urban inner city population.

Conditions

Eligibility

Eligible Ages
Between 40 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients suffering from symptomatic knee OA (uni/bi lateral) for at least six months, fulfilling the ACR clinical criteria for OA of the knee, and having radiographically assessed OA of the knee according to the Kellgren and Lawrence scale.
  • Patients with VAS pain score of ≥3cm (measured at baseline).
  • Males and females between the ages of 40-75.
  • 17<BMI<40
  • Ambulatory and active patients that can participate in a rehabilitation program that includes daily walking
  • Stable medical regimen (no recent changes to the pain medication within a month)
  • Able to walk at least 50 meters and scored positive on the STEADI test
  • Able to understand, read and sign the informed consent form
  • English or Spanish speaking

Exclusion Criteria

  • Patients suffering from acute septic arthritis.
  • Patients suffering from inflammatory joint disease such as rheumatoid arthritis.
  • Patients with diagnosis of avascular necrosis of the knee.
  • Patients with diagnosis of neuromuscular disease.
  • Patients with more than 3 falls in the last 12 months, OR any fall with an injury in the last 12 months.
  • Patients exhibiting a lack of physical or mental ability to perform or comply with the study procedure.
  • Patients with a history of pathological osteoporotic fracture
  • Patients with referred pain in the knees from back or hip joint symptoms.
  • Patients with severe back pain, ≥ 4 cm in visual analogue scale (0-10) [1] or radiating leg pain
  • Patients with generalized body pain (both upper and lower extremities, such as fibromyalgia
  • No major surgery to the affected limb and contralateral limb (e.g. no joint replacements or surgical fracture repair)
  • No major cardiovascular comorbidities (able to enroll in an active exercise program)
  • Patient started on lipid lowering medication in last 3 months
  • Any change in blood pressure medications
  • No recent physical therapy (no more recent than 6 months) on the affected limb
  • No active heart disease (ischemia or heart failure admissions within 6 months) and no active COPD (exacerbation within 6 months)
  • No active malignancies on ongoing treatment
  • Patient with neurological gait pattern
  • Patient requiring assistive device during gait analysis.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Single blinded (evaluator), single-center, randomized controlled trial. Interventional and Control group with option for Control group to Cross over.
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
The outcomes assessor is the only one masked in the study. Assessor is independent of the randomization, trial coordination, and care providers.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Traditional Physical Therapy
Participants will have traditional physical therapy up to 20 sessions, up to two sessions per week. This will involve exercise and modalities as decided by the therapists and medical providers. Participants will have a home exercise program for the remainder of the year.
  • Other: Traditional Physical Therapy
    Up to 20 sessions of traditional physical therapy
Experimental
AposTherapy
Participants will have AposTherapy instead of traditional physical therapy over the course of one year. This will include 7 sessions of gait assessment and re-calibration with daily at home exercise with the device over the year.
  • Device: AposTherapy
    AposTherapy is a home-based exercise program utilizing footwear that causes exercise with normal daily activity that may significantly improve function in patients with knee pain in general, and specifically knee osteoarthritis (OA).

Recruiting Locations

Montefiore Medical Center - Moses Campus
Bronx, New York 10467
Contact:
Beendu P Pujar, MD
518-596-0510
bpujar@montefiore.org

More Details

NCT ID
NCT03171168
Status
Recruiting
Sponsor
Montefiore Medical Center

Study Contact

Sewon Lee, MD
7189207590
sewlee@montefiore.org

Detailed Description

AposTherapy is a home-based exercise program utilizing footwear that causes exercise with normal daily activity that may significantly improve function in patients with knee pain in general, and specifically knee osteoarthritis (OA). Capitalizing on the reported excellent adherence and clinical benefit of Apos Therapy in patients with significant lower limb arthritis, the investigators propose to evaluate this as a conservative treatment that may supplant/supplement traditional pain medications and physical therapy in knee OA population.

A potential use of AposTherapy as a replacement for traditional physical therapy may yield a less costly, more effective therapy with better adherence. Problems with traditional therapy include poor patient adherence (patients often do not complete the sessions and have very poor adherence (about 50-60%) to home therapy programs), added cost of travel (which may be more than $100 per session for ambulette or access-a-ride for eligible patients), and the lack of continuation in an ongoing exercise program, leading to relapse and need for retreatment. Additionally, access to physical therapy is limited for many patients since there are not enough available outpatient therapy services to meet the needs of all patients. Finding an alternative exercise program that will increase adherence, decrease total therapy visits, and improve patient's outcomes with decreased dependence on pain medications is a high priority from both patient care and cost management perspectives.

AposTherapy potentially overcomes many of these issues with improving/modifying abnormal biomechanics (therefore decreasing pain), and a home-based exercise program utilizing footwear that causes exercise with normal activity by promoting perturbation. This biomechanical approach may significantly reduce pain and improve function in patients with knee OA. Capitalizing on the reported excellent adherence and clinical benefit of AposTherapy in patients with significant knee OA, the investigators propose to evaluate the biomechanical exercise (wearing an appropriately calibrated shoe at home for a prescribed amount of time each day) as a conservative treatment that may supplement or supplant traditional pain medications, interventional pain procedures and physical therapy in an at-risk urban inner city population with knee OA.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.