Study Results
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View full resultsBasic Information
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TERMINATED
NA
54 participants
INTERVENTIONAL
2016-11-30
2019-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Traditional Physical Therapy
Up to 20 sessions of traditional physical therapy
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.
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).
Interventions
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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).
Traditional Physical Therapy
Up to 20 sessions of traditional physical therapy
Eligibility Criteria
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Inclusion Criteria
* Patients with a Visual Analog Scale (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 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 Chronic Obstructive Pulmonary Disease (COPD) (exacerbation within 6 months)
* No active malignancies on ongoing treatment
* Patient with neurological gait pattern
* Patient requiring assistive device during gait analysis.
40 Years
75 Years
ALL
No
Sponsors
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Apos Medical and Sports Technology Ltd.
INDUSTRY
Montefiore Medical Center
OTHER
Responsible Party
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Matthew Bartels
Professor and Chairman of Rehabilitation Medicine Albert Einstein College of Medicine
Principal Investigators
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Matthew Bartels, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Countries
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References
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Jones KR, Vojir CP, Hutt E, Fink R. Determining mild, moderate, and severe pain equivalency across pain-intensity tools in nursing home residents. J Rehabil Res Dev. 2007;44(2):305-14. doi: 10.1682/jrrd.2006.05.0051.
Verghese J, Lipton RB, Hall CB, Kuslansky G, Katz MJ, Buschke H. Abnormality of gait as a predictor of non-Alzheimer's dementia. N Engl J Med. 2002 Nov 28;347(22):1761-8. doi: 10.1056/NEJMoa020441.
Elbaz A, Mor A, Segal G, Aloni Y, Teo YH, Teo YS, Das-De S, Yeo SJ. Patients with knee osteoarthritis demonstrate improved gait pattern and reduced pain following a non-invasive biomechanical therapy: a prospective multi-centre study on Singaporean population. J Orthop Surg Res. 2014 Jan 2;9:1. doi: 10.1186/1749-799X-9-1.
Haim A, Segal G, Elbaz A, Mor A, Agar G, Bar-Ziv Y, Beer Y, Morag G, Debi R, Atoun E. The outcome of a novel biomechanical therapy for patients suffering from anterior knee pain. Knee. 2013 Dec;20(6):595-9. doi: 10.1016/j.knee.2012.11.009. Epub 2012 Dec 27.
Drexler M, Elbaz A, Mor A, Debi R, Debbi EM, Haim A, Lador R, Salai M, Segal G. Effects of a customized biomechanical therapy on patients with medial compartment knee osteoarthritis. Ann Phys Rehabil Med. 2012 May;55(4):213-28. doi: 10.1016/j.rehab.2012.01.002. Epub 2012 Mar 27. English, French.
Segal G, Bar-Ziv Y, Velkes S, Benkovich V, Stanger G, Debbi EM, Debi R, Mor A, Elbaz A. A non-invasive biomechanical device and treatment for patients following total hip arthroplasty: results of a 6-month pilot investigation. J Orthop Surg Res. 2013 May 21;8:13. doi: 10.1186/1749-799X-8-13.
Forkan R, Pumper B, Smyth N, Wirkkala H, Ciol MA, Shumway-Cook A. Exercise adherence following physical therapy intervention in older adults with impaired balance. Phys Ther. 2006 Mar;86(3):401-10.
Sihvonen R, Paavola M, Malmivaara A, Itala A, Joukainen A, Nurmi H, Kalske J, Jarvinen TL; Finnish Degenerative Meniscal Lesion Study (FIDELITY) Group. Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear. N Engl J Med. 2013 Dec 26;369(26):2515-24. doi: 10.1056/NEJMoa1305189.
Abbott JH, Robertson MC, Chapple C, Pinto D, Wright AA, Leon de la Barra S, Baxter GD, Theis JC, Campbell AJ; MOA Trial team. Manual therapy, exercise therapy, or both, in addition to usual care, for osteoarthritis of the hip or knee: a randomized controlled trial. 1: clinical effectiveness. Osteoarthritis Cartilage. 2013 Apr;21(4):525-34. doi: 10.1016/j.joca.2012.12.014. Epub 2013 Jan 8.
Fitzgerald GK, Hinman RS, Zeni J Jr, Risberg MA, Snyder-Mackler L, Bennell KL. OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of rehabilitation interventions for osteoarthritis. Osteoarthritis Cartilage. 2015 May;23(5):803-14. doi: 10.1016/j.joca.2015.03.013.
Lim BW, Hinman RS, Wrigley TV, Sharma L, Bennell KL. Does knee malalignment mediate the effects of quadriceps strengthening on knee adduction moment, pain, and function in medial knee osteoarthritis? A randomized controlled trial. Arthritis Rheum. 2008 Jul 15;59(7):943-51. doi: 10.1002/art.23823.
Tanaka R, Ozawa J, Kito N, Moriyama H. Efficacy of strengthening or aerobic exercise on pain relief in people with knee osteoarthritis: a systematic review and meta-analysis of randomized controlled trials. Clin Rehabil. 2013 Dec;27(12):1059-71. doi: 10.1177/0269215513488898. Epub 2013 Jul 4.
Skou ST, Rasmussen S, Laursen MB, Rathleff MS, Arendt-Nielsen L, Simonsen O, Roos EM. The efficacy of 12 weeks non-surgical treatment for patients not eligible for total knee replacement: a randomized controlled trial with 1-year follow-up. Osteoarthritis Cartilage. 2015 Sep;23(9):1465-75. doi: 10.1016/j.joca.2015.04.021. Epub 2015 Apr 30.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2015-4842
Identifier Type: -
Identifier Source: org_study_id