Trial Outcomes & Findings for Efficacy of AposTherapy® in Knee OA (NCT NCT03153956)
NCT ID: NCT03153956
Last Updated: 2020-03-24
Results Overview
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.
TERMINATED
NA
77 participants
screening, 3 months, 6 months, 9 months, and 12 months
2020-03-24
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
38
|
|
Overall Study
COMPLETED
|
39
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Active Treatment Arm
n=39 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.
|
Control Arm
n=38 Participants
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.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 9 • n=39 Participants
|
61 years
STANDARD_DEVIATION 8.2 • n=38 Participants
|
61 years
STANDARD_DEVIATION 8.6 • n=77 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=39 Participants
|
27 Participants
n=38 Participants
|
54 Participants
n=77 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=39 Participants
|
11 Participants
n=38 Participants
|
23 Participants
n=77 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: screening, 3 months, 6 months, 9 months, and 12 monthsPopulation: 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)
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.
Outcome measures
| Measure |
Active Treatment Arm
n=38 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.
|
Control Arm
n=34 Participants
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.
|
|---|---|---|
|
Western Ontario and McMaster University (WOMAC) Total Score
WOMAC Total score - screen
|
1062.7 score on a scale
Standard Deviation 545.96
|
975.1 score on a scale
Standard Deviation 580.87
|
|
Western Ontario and McMaster University (WOMAC) Total Score
WOMAC Total score - 3 months
|
548.8 score on a scale
Standard Deviation 440.22
|
601.1 score on a scale
Standard Deviation 467.39
|
|
Western Ontario and McMaster University (WOMAC) Total Score
WOMAC Total Score - 6 months
|
420.2 score on a scale
Standard Deviation 391.7
|
524.8 score on a scale
Standard Deviation 448.83
|
|
Western Ontario and McMaster University (WOMAC) Total Score
WOMAC Total Score - 9 months
|
—
|
280.2 score on a scale
Standard Deviation 194.84
|
|
Western Ontario and McMaster University (WOMAC) Total Score
WOMAC Total Score - 12 months
|
396.5 score on a scale
Standard Deviation 324.99
|
433 score on a scale
Standard Deviation 352.32
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Data was not collected for this outcome measure due to study termination.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: screening, 3 months, 6 months, 9 months, and 12 monthsPopulation: 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)
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.
Outcome measures
| Measure |
Active Treatment Arm
n=38 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.
|
Control Arm
n=37 Participants
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.
|
|---|---|---|
|
Short-Form 36 (SF-36) Total Score
SF-36 total score - screening
|
55.6 score on a scale
Standard Deviation 15.03
|
56.6 score on a scale
Standard Deviation 16.77
|
|
Short-Form 36 (SF-36) Total Score
SF-36 total score - 3 months
|
64.6 score on a scale
Standard Deviation 16.8
|
63.0 score on a scale
Standard Deviation 17.09
|
|
Short-Form 36 (SF-36) Total Score
SF-36 total score - 6 months
|
69.7 score on a scale
Standard Deviation 14.8
|
68 score on a scale
Standard Deviation 17.21
|
|
Short-Form 36 (SF-36) Total Score
SF-36 total score - 9 months
|
—
|
74.5 score on a scale
Standard Deviation 6.37
|
|
Short-Form 36 (SF-36) Total Score
SF-36 total score - 12 month
|
71 score on a scale
Standard Deviation 9.77
|
66.6 score on a scale
Standard Deviation 15.38
|
Adverse Events
Active Treatment Arm
Control Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place