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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Adults 18 to 30, inclusive
  2. Able to provide written informed consent
  3. Have received a VICTORY Patch if in treatment group.
  4. Is an athlete on a University of Arizona Varsity Athletic Team
  5. Agree to having physical activity objectively measured for physical activity, as well as attendance, and participation in intervention.
  6. Agree to place an adhesive patch on their skin, as instructed, based on selection group.

Exclusion Criteria:

  1. Use of drugs of abuse (illicit or prescription)
  2. Have an implanted device, or wears, or adheres any electrical device to the body during the study, other than a hearing aid.
  3. Any current medical or musculoskeletal injury that would prohibit athletic participation
  4. Any significant injuries in the last month prior to the intervention that may impact tested performance measures.
  5. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: VICTORY PATCH
Drug- free, non-invasive patch (VICTORY Patch) with haptic vibrotactile trigger technology (VTT)
Other Names:
  • Haptic Vibrotactile Trigger Technology
  • VTT
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.
Device: Sham Patch without VTT
Sham Patch without haptic vibrotactile trigger technology (VTT)
Other Names:
  • Sham Comparator
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.
Device: VICTORY PATCH
Drug- free, non-invasive patch (VICTORY Patch) with haptic vibrotactile trigger technology (VTT)
Other Names:
  • Haptic Vibrotactile Trigger Technology
  • VTT
Device: Sham Patch without VTT
Sham Patch without haptic vibrotactile trigger technology (VTT)
Other Names:
  • Sham Comparator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SuperPatch Limited LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Arizona
Clarity Science LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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