Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Knee injury and Osteoarthritis Outcome Score (KOOS): Pain score |
The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function & Daily Living, Sports & Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems. |
20 weeks |
|
Primary |
Knee injury and Osteoarthritis Outcome Score (KOOS): Symptoms score |
The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function & Daily Living, Sports & Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems. |
20 weeks |
|
Primary |
Knee injury and Osteoarthritis Outcome Score (KOOS): Function in Activities of Daily Living (ADL) score |
The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function & Daily Living, Sports & Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems. |
20 weeks |
|
Primary |
Knee injury and Osteoarthritis Outcome Score (KOOS): Function in Sports and Recreation score |
The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function & Daily Living, Sports & Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems. |
20 weeks |
|
Primary |
Knee injury and Osteoarthritis Outcome Score (KOOS): Quality of Life score |
The KOOS survey was chosen due to its repeatability, and it gave scores of 0-100 for four separate categories: Symptoms, Pain, Function & Daily Living, Sports & Recreational Activities, and Quality of Life. Under KOOS scoring guidelines, a score of zero represents extreme knee problems, and 100 represents complete function of the knee with no pain, discomfort, or other joint related problems. |
20 weeks |
|
Primary |
C-Reactive Protein |
C-Reactive Protein levels were measured at T0 for baseline scores, and then measured again at T1, T2, and T3. As CRP levels are biomarkers of systemic inflammation, it was expected to see a decrease in CRP levels when taking AuNP Supplement. |
20 weeks |
|
Primary |
Range of Motion Bilateral Flexion score |
All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats. |
20 weeks |
|
Primary |
Leg Press repetition number |
All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats. |
20 weeks |
|
Primary |
6-minute Walk distance (meter) |
All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats. |
20 weeks |
|
Primary |
Sit-to Stand repetition number |
All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats. |
20 weeks |
|
Primary |
Single Leg Squats repetition number |
All participants completed a physical assessment conducted by an assigned physical therapist: Range of Motion Bilateral Flexion, Leg Press, Walk Test, Sit-to Stand and Single Leg Squats. |
20 weeks |
|
Secondary |
Number of Event for Loss of Balance (LOB) |
DorsaVi Assessments: Loss of Balance (LOB), Movement efficiency index, Squat Lumbar Flexion Deviation, Squat Lateral Shift Deviations, single leg squat scores, speed, and tibial inclination |
20 weeks |
|
Secondary |
Movement efficiency index |
DorsaVi Assessments: Loss of Balance (LOB), Movement efficiency index, Squat Lumbar Flexion Deviation, Squat Lateral Shift Deviations, single leg squat scores, speed, and tibial inclination |
20 weeks |
|
Secondary |
Squat Lumbar Flexion Deviation score |
DorsaVi Assessments: Loss of Balance (LOB), Movement efficiency index, Squat Lumbar Flexion Deviation, Squat Lateral Shift Deviations, single leg squat scores, speed, and tibial inclination |
20 weeks |
|
Secondary |
Squat Lateral Shift Deviation score |
DorsaVi Assessments: Loss of Balance (LOB), Movement efficiency index, Squat Lumbar Flexion Deviation, Squat Lateral Shift Deviations, single leg squat scores, speed, and tibial inclination |
20 weeks |
|
Secondary |
single leg squat speed |
DorsaVi Assessments: Loss of Balance (LOB), Movement efficiency index, Squat Lumbar Flexion Deviation, Squat Lateral Shift Deviations, single leg squat scores, speed, and tibial inclination |
20 weeks |
|
Secondary |
single leg squat tibial inclination |
DorsaVi Assessments: Loss of Balance (LOB), Movement efficiency index, Squat Lumbar Flexion Deviation, Squat Lateral Shift Deviations, single leg squat scores, speed, and tibial inclination |
20 weeks |
|
Secondary |
Percentage of participants that would continue taking the product after the study ended. |
Acceptability of AuNP Supplement was analyzed at the end of the study. Participants were asked if they would continue taking the product after the study in their final exit survey. |
20 weeks |
|