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The Effect of AposTherapy on Knee Pain (AposKnee)

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ClinicalTrials.gov Identifier: NCT03171168
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : March 26, 2018
Sponsor:
Collaborator:
Apos Medical and Sports Technology Ltd.
Information provided by (Responsible Party):
Matthew Bartels, Montefiore Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Knee Pain Device: AposTherapy Other: Traditional Physical Therapy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 147 participants
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.
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.
Primary Purpose: Treatment
Official Title: The Effect of AposTherapy on Pain and Function in Knee Osteoarthritis Population: A Randomized Controlled Trial
Actual Study Start Date : November 30, 2016
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. Knee Pain and Function [ Time Frame: 1 year ]
    Improvement in Pain and Function Assessed with a questionnaire


Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 1 year ]
    Assessed with a questionnaire -SF-36 (Short Form Health Survey)

  2. PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference and Physical Function [ Time Frame: 1 year ]
    Pain and Function measured through PROMIS short forms.

  3. Medication Costs [ Time Frame: 1 year ]
    Change in Medication costs assessed by patient interview.

  4. Healthcare utilization [ Time Frame: 1 year ]
    Change in healthcare facility utilization assessed by patient interview.

  5. Gait assessment [ Time Frame: 1 year ]
    Objective assessment of the patients' gait assessed with gait analysis equipment

  6. Pain medication consumption [ Time Frame: 1 year ]
    Medication consumption

  7. 6-min walk test [ Time Frame: 1 year ]
    objective assessment using maximum distance comfortably walked in 6 minutes on a 100 foot closed course

  8. Blood pressure [ Time Frame: 1 year ]
    Increase/ decrease in Blood Pressure, physiological parameter

  9. resting heart rate [ Time Frame: 1 year ]
    Increase/ decrease in resting heart rate, physiological parameter

  10. Overall activity [ Time Frame: 1 year ]
    Measure in daily steps taken assessed with a wristband device

  11. sleep patterns [ Time Frame: 1 year ]
    Measured as total sleep time in minutes assessed with a wristband device



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03171168


Contacts
Contact: Sewon Lee, MD 7189207590 sewlee@montefiore.org
Contact: Matthew N Bartels, MD, MPH 7189202751 mbartels@montefiore.org

Locations
United States, New York
Montefiore Medical Center - Moses Campus Recruiting
Bronx, New York, United States, 10467
Contact: Beendu P Pujar, MD    518-596-0510    bpujar@montefiore.org   
Principal Investigator: Matthew N Bartels, MD, MPH         
Sponsors and Collaborators
Montefiore Medical Center
Apos Medical and Sports Technology Ltd.
Investigators
Principal Investigator: Matthew Bartels, MD, MPH Montefiore Medical Center

Publications:

Responsible Party: Matthew Bartels, Professor and Chairman of Rehabilitation Medicine Albert Einstein College of Medicine, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03171168     History of Changes
Other Study ID Numbers: 2015-4842
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Matthew Bartels, Montefiore Medical Center:
Gait Analysis
WOMAC
SF-36

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases