Efficacy of AposTherapy® in Knee OA
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|ClinicalTrials.gov Identifier: NCT03153956|
Recruitment Status : Terminated (Halt in funding)
First Posted : May 15, 2017
Results First Posted : March 24, 2020
Last Update Posted : March 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Device: Calibrated AposTherapy® Device: Non-Calibrated Sham Apos Therapy Device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
Phase I - A prospective, interventional, randomized, double-arm clinical evaluation of patients who have been diagnosed with OA of the knee. The active treatment arm (personally calibrated biomechanical device) will be compared to a control arm (sham-placebo device) (similar shoes without biomechanical elements).
Phase II - Open-label, cross-over study design. After the completion of phase one patients will be un-blinded to their group allocation. Patients that were allocated to the sham-placebo control group will cross to the active group and will receive the AposTherapy treatment. Patients that were allocated to the active group will continue with treatment.
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized Double-Armed Efficacy Evaluation of AposTherapy® for the Treatment of Knee Osteoarthritis|
|Actual Study Start Date :||April 16, 2015|
|Actual Primary Completion Date :||November 15, 2018|
|Actual Study Completion Date :||November 15, 2018|
Experimental: Active Treatment Arm
Personally calibrated bio-mechanical device
Device: Calibrated AposTherapy®
a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology.
Placebo Comparator: Control Arm
sham-placebo device (similar shoes without bio-mechanical elements).
Device: Non-Calibrated Sham Apos Therapy Device
The comparator group will receive a non-calibrated sham device.
- Western Ontario and McMaster University (WOMAC) Total Score [ Time Frame: screening, 3 months, 6 months, 9 months, and 12 months ]WOMAC evaluates the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. In this study, WOMAC scores were recomputed as the sum within sub-scales (pain score is the sum of questions 1-5; stiffness is the sum of questions 6-7; functional score is the sum of questions 8-24). The total score is reported as the sum of the pain, stiffness, and functional sub-scores for all participants. The total score range is 0-1292. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
- Visual Analog Score (VAS) Score [ Time Frame: 12 Months ]The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
- Short-Form 36 (SF-36) Total Score [ Time Frame: screening, 3 months, 6 months, 9 months, and 12 months ]The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The survey consists eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0-100, with lower scores = more disability and higher scores = less disability. Therefore, higher scores represent better health.
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): NCT03153956
|United States, New York|
|New York University School of Medicine|
|New York, New York, United States, 10016|
|Principal Investigator:||Dennis Cardone, DO||NYU Langone Health|