- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06430879
Performance Output With Haptics - Evaluating Athlete Response and Unrealized Potential (POWER-UP)
December 5, 2025 updated by: SuperPatch Limited LLC
POWER-UP Trial (Performance Output With Haptics - Evaluating Athlete Response and Unrealized Potential)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85721
- University of Arizona
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Adults 18 to 30, inclusive
- Able to provide written informed consent
- Have received a VICTORY Patch if in treatment group.
- Is an athlete on a University of Arizona Varsity Athletic Team
- Agree to having physical activity objectively measured for physical activity, as well as attendance, and participation in intervention.
- Agree to place an adhesive patch on their skin, as instructed, based on selection group.
Exclusion Criteria:
- Use of drugs of abuse (illicit or prescription)
- Have an implanted device, or wears, or adheres any electrical device to the body during the study, other than a hearing aid.
- Any current medical or musculoskeletal injury that would prohibit athletic participation
- Any significant injuries in the last month prior to the intervention that may impact tested performance measures.
- New injuries that occur during the course of study testing that may impact performance measures.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Active/Treatment
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.
|
Drug- free, non-invasive patch (VICTORY Patch) with haptic vibrotactile trigger technology (VTT)
Other Names:
|
|
Sham Comparator: Non-Active/Control
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.
|
Sham Patch without haptic vibrotactile trigger technology (VTT)
Other Names:
|
|
Other: Crossover
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.
|
Drug- free, non-invasive patch (VICTORY Patch) with haptic vibrotactile trigger technology (VTT)
Other Names:
Sham Patch without haptic vibrotactile trigger technology (VTT)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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.
Time Frame: 10 days
|
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.
Time Frame: 10 days
|
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.
Time Frame: 10 days
|
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.
Time Frame: 10 days
|
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
|
|
Changes in subject performance and strength and intensity/interference scores among and between the treated group and the control group for the athlete.
Time Frame: 10 days
|
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
|
Secondary Outcome Measures
Outcome Measure |
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.
Time Frame: 10 days
|
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.
|
10 days
|
Other Outcome Measures
Outcome Measure |
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
Time Frame: 10 days
|
Evaluation of reported side effects during study period based on self-report by subject or reported by clinician investigator.
|
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mark Sakr, DO, University of Arizona
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 10, 2024
Primary Completion (Actual)
November 1, 2024
Study Completion (Actual)
November 1, 2024
Study Registration Dates
First Submitted
May 10, 2024
First Submitted That Met QC Criteria
May 20, 2024
First Posted (Actual)
May 28, 2024
Study Record Updates
Last Update Posted (Actual)
December 15, 2025
Last Update Submitted That Met QC Criteria
December 5, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- POWER-UP 001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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