The Effect of AposTherapy on Knee Pain

NCT03171168 | Terminated Results FDA Device

• 1 other identifier: 2015-4842
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Knee Pain

Keywords

Gait Analysis; WOMAC; SF-36 (Short Form 36)

Outcome Measures

Primary Outcomes (1)

• Knee Pain and Function

  Improvement in Pain and Function as assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scale. The WOMAC, a self-administered instrument, is 1 of 3 subscales comprising the WOMAC Index. As a standalone measure, the WOMAC pain scale contains 5 items that address the following person-level activities: walking, using stairs, in bed, sitting or lying down, and standing upright. The stem of the scale asks the patient to focus on the extent of pain experienced in the involved knee during each of these activities which are reported on a 0-4 Likert scale: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4), with a possible score range of 0-20 for Pain. Higher scores on the WOMAC are associated with worse knee pain.

  24 weeks

Secondary Outcomes (4)

• Quality of Life by RAND SF-36 (RAND Corporation Short Form 36)

  24 weeks

• PROMIS (Patient-Reported Outcomes Measurement Information System) Pain Interference and Physical Function

  24 weeks

• Gait Assessment

  24 weeks

• 6-min Walk Test

  24 weeks

Study Arms (2)

Traditional Physical Therapy

ACTIVE COMPARATOR

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

AposTherapy

EXPERIMENTAL

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

Interventions

AposTherapy DEVICE

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).

AposTherapy

Traditional Physical Therapy OTHER

Up to 20 sessions of traditional physical therapy

Traditional Physical Therapy

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients suffering from symptomatic knee OA (uni/bi lateral) for at least six months, fulfilling the American College of Rheumatology (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 a Visual Analog Scale (VAS) pain score of ≥3cm (measured at baseline).
• Males and females between the ages of 40-75.
• \<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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Apos Medical and Sports Technology Ltd.: collaborator

Study Sites (1)

Montefiore Medical Center - Moses Campus

The Bronx, New York, 10467, United States

Location

Related Publications (13)

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  PMID: 17551881 BACKGROUND

• 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.

  PMID: 12456852 BACKGROUND

• 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.

  PMID: 24383821 BACKGROUND

• 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.

  PMID: 23273535 BACKGROUND

• 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.

  PMID: 22521468 BACKGROUND

• 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.

  PMID: 23692690 BACKGROUND

• 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.

  PMID: 16506876 BACKGROUND

• 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.

  PMID: 24369076 BACKGROUND

• 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.

  PMID: 23313532 BACKGROUND

• 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.

  PMID: 25952351 BACKGROUND

• 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.

  PMID: 18576289 BACKGROUND

• 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.

  PMID: 23828186 BACKGROUND

• 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.

  PMID: 25937024 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Matthew Bartels
• Organization: Montefiore Medical Center

MBARTELS@montefiore.org

(914) 597-2332

Study Officials

• Matthew Bartels, MD, MPH

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor is the only one masked in the study. Assessor is independent of the randomization, trial coordination, and care providers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman of Rehabilitation Medicine Albert Einstein College of Medicine

Model Details: Single blinded (evaluator), single-center, randomized controlled trial. Interventional and Control group with option for Control group to Cross over.

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: May 31, 2017
• Study Start: November 30, 2016
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: December 14, 2022
• Results First Posted: December 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)