Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Arizona | OTHER |
| Clarity Science LLC | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
This minimal risk, randomized, double-blind, placebo controlled Institutional Review Board (IRB)-approved observational study with functional measurements, will evaluate athletic performance after use of a drug- free, non-invasive patch (VICTORY Patch; The Super Patch Company Inc.); using KangaTech, Catapult and Force Plates along with crossover control of trials within the same subject group not receiving an 'active' patch.
Emerging technologies that use haptic (skin pressure) technology have been studied and have shown positive improvements in stress levels, balance, sleep, and pain. The VICTORY patch (SuperPatch Company, Toronto, Canada) that also incorporates this technology has shown anecdotal promise to improve athlete performance. With the tools currently in use at the University of Arizona, team coaches and physicians can measure the true impact of neuromuscular changes suggested by the VICTORY patch. This study will measure quadriceps and hamstring strength in isolation as well as peak output in jumping and speed testing within in season training programs with and without VICTORY patch use. When combined with new methods of assessing individual muscle strength (KangaTech) and Force plate as well as Catapult measurements of compound movements of the investigational muscles, the investigators can evaluate the true performance and changes in football athletes with the SuperPatch technology.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active/Treatment | Active Comparator | Data will be collected for athletes prior to first use of patch and then 2-3 days later with the active patch (VICTORY PATCH). Follow-up functional measurements will also be taken at 7 and 9-10 days after baseline with second crossover patch use 9-10 days post-baseline. |
|
| Non-Active/Control | Sham Comparator | Data will be collected for athletes prior to first use of patch and then 2-3 days later with the inactive patch. Follow-up functional measurements will also be taken at 7 and 9-10 days after baseline with second crossover patch use 9-10 days post-baseline. |
|
| Crossover | Other | Data will be collected for athletes prior to first use of patch and then 2-3 days later with the active or inactive patch. Follow-up functional measurements will also be taken at 7 and 9-10 days after baseline with second crossover patch use 9-10 days post-baseline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VICTORY PATCH | Device | Drug- free, non-invasive patch (VICTORY Patch) with haptic vibrotactile trigger technology (VTT) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in subject performance and strength and intensity/interference scores among and between the treated group and the control group for the athlete. | Evaluation of change in quadriceps and hamstring function via KangaTech measurements (mm/Kg) | 10 days |
| Changes in subject performance and strength and intensity/interference scores among and between the treated group and the control group for the athlete. | Evaluation of change in max power of the Ground Reaction Force (GRF) in quadriceps and hamstring function measured by the Vald force plate (F = m * a ; 1 m/s2). | 10 days |
| Changes in subject performance and strength and intensity/interference scores among and between the treated group and the control group for the athlete. | Evaluation of of Catapult Global Positioning System (GPS) and change in quadriceps and hamstring function to capture maximum acceleration and maximum speed (meters per second (m/s)) during their field workout. | 10 days |
| Changes in subject performance and strength and intensity/interference scores among and between the treated group and the control group for the athlete. | Evaluation of change in subject response to The Borg Rating of Perceived Exertion (RPE) (scale= 1- 10) | 10 days |
| Changes in performance based on patch location or playing position with the VICTORY Patch treatment. | Evaluation of performance (overall scores) based on concentration of patch placement among study subjects on either dominant medial forearm or dominant side, or mid-anterior thigh. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of subject phenotype(s) that will have the optimal response to treatment with the VICTORY Patch, as well as athletes having the least positive response. | Evaluation of predictive baseline metrics of playing position and predictive modeling will be used to identify subject phenotype(s) with an optimal, and a least positive, response. The data used as inputs to construct the predictive models will be a collection of the survey results collected from patients at day 0. Optimal and least positive responses will be defined based on changes in performance and other functional measurement scores, and changes in concomitant medications used, in the treatment group between survey dates. |
| Measure | Description | Time Frame |
|---|---|---|
| Any side effects reported by patients with be documented in athletic training electronic medical record and assessed by team physician and PI | Evaluation of reported side effects during study period based on self-report by subject or reported by clinician investigator. | 10 days |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mark Sakr, DO | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85721 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
Randomized, double-blind, placebo controlled, crossover trial with functional measurements
Not provided
Not provided
Not provided
| Sham Patch without VTT | Device | Sham Patch without haptic vibrotactile trigger technology (VTT) |
|
|
| 10 days |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |