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Completed

NCT Number: NCT06430879

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.

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Key information

Conditions

Muscle Strength Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona

Tucson, Arizona, 85721, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VICTORY PATCH

Device

Drug- free, non-invasive patch (VICTORY Patch) with haptic vibrotactile trigger technology (VTT)

Other names: Haptic Vibrotactile Trigger Technology, VTT

Sham Patch without VTT

Device

Sham Patch without haptic vibrotactile trigger technology (VTT)

Other names: Sham Comparator

Primary outcomes

  1. 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)

  2. 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).

  3. 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.

  4. 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)

  5. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

SuperPatch Limited LLC

Industry

Collaborators

  • Clarity Science LLC
  • University of Arizona

Registry information

Official study title

POWER-UP Trial (Performance Output With Haptics - Evaluating Athlete Response and Unrealized Potential)

Acronym: POWER-UP

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 28, 2024
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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