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Halt in funding
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A prospective, interventional, randomized, double-arm clinical evaluation study to examine the efficacy of AposTherapy® versus a control group, in the short-term at 6 months and in the long-term at 12 months post-treatment, with the primary efficacy assessment based on improvement in knee pain score and improvement in function in patients following diagnosis of knee osteoarthritis (OA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment Arm | Experimental | Personally calibrated bio-mechanical device |
|
| Control Arm | Placebo Comparator | sham-placebo device (similar shoes without bio-mechanical elements). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calibrated AposTherapy® | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster University (WOMAC) Total Score | 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. | screening, 3 months, 6 months, 9 months, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Score (VAS) Score | 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. | 12 Months |
| Short-Form 36 (SF-36) Total Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Cardone, DO | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Treatment Arm | Personally calibrated bio-mechanical 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. |
| FG001 | Control Arm | sham-placebo device (similar shoes without bio-mechanical elements). Non-Calibrated Sham Apos Therapy Device: The comparator group will receive a non-calibrated sham device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Treatment Arm | Personally calibrated bio-mechanical 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Western Ontario and McMaster University (WOMAC) Total Score | 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. | Participants who scheduled visits beyond 4 days before or after the specified timeframes (3, 6, and 9 months from screening) were not included in the analysis. (Treatment participants did not have a 9 month visit) | Posted | Mean | Standard Deviation | score on a scale | screening, 3 months, 6 months, 9 months, and 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Treatment Arm | Personally calibrated bio-mechanical 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dennis A. Cardone, DO | NYU Langone Health | +1 646 501 7223 | Dennis.Cardone@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 23, 2015 | Feb 21, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| D007592 | Joint Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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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.
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| Non-Calibrated Sham Apos Therapy Device | Device | The comparator group will receive a non-calibrated sham device. |
|
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. |
| screening, 3 months, 6 months, 9 months, and 12 months |
| Control Arm |
sham-placebo device (similar shoes without bio-mechanical elements). Non-Calibrated Sham Apos Therapy Device: The comparator group will receive a non-calibrated sham device. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Personally calibrated bio-mechanical 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. |
| OG001 | Control Arm | sham-placebo device (similar shoes without bio-mechanical elements). Non-Calibrated Sham Apos Therapy Device: The comparator group will receive a non-calibrated sham device. |
|
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| Secondary | Visual Analog Score (VAS) Score | 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. | Data was not collected for this outcome measure due to study termination. | Posted | 12 Months |
|
|
| Secondary | Short-Form 36 (SF-36) Total Score | 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. | Participants who scheduled visits beyond 4 days before or after the specified timeframes (3, 6, and 9 months from screening) were not included in the analysis. (Treatment participants did not have a 9 month visit) | Posted | Mean | Standard Deviation | score on a scale | screening, 3 months, 6 months, 9 months, and 12 months |
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| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Control Arm | sham-placebo device (similar shoes without bio-mechanical elements). Non-Calibrated Sham Apos Therapy Device: The comparator group will receive a non-calibrated sham device. | 0 | 38 | 0 | 38 | 0 | 38 |
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| SF-36 total score - 3 months |
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| SF-36 total score - 6 months |
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| SF-36 total score - 9 months |
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| SF-36 total score - 12 month |
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