Performance Output With Haptics - Evaluating Athlete Response and Unrealized Potential

NCT ID: NCT06430879

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2024-11-01

Brief Summary

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.

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.

Conditions

Muscle Strength; Muscle Weakness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

VICTORY PATCH

Intervention Type: DEVICE

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

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.

Group Type: SHAM_COMPARATOR

Sham Patch without VTT

Intervention Type: DEVICE

Sham Patch without haptic vibrotactile trigger technology (VTT)

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.

Group Type: OTHER

VICTORY PATCH

Intervention Type: DEVICE

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

Sham Patch without VTT

Intervention Type: DEVICE

Sham Patch without haptic vibrotactile trigger technology (VTT)

Interventions

VICTORY PATCH

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

Intervention Type: DEVICE

Sham Patch without VTT

Sham Patch without haptic vibrotactile trigger technology (VTT)

Intervention Type: DEVICE

Other Intervention Names

Haptic Vibrotactile Trigger Technology; VTT; Sham Comparator

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arizona

OTHER

Sponsor Role: collaborator

Clarity Science LLC

UNKNOWN

Sponsor Role: collaborator

SuperPatch Limited LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Sakr, DO

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University of Arizona

Tucson, Arizona, United States

Countries

United States

Other Identifiers

POWER-UP 001

Identifier Type: -

Identifier Source: org_study_id