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

SuperPatch Limited LLC

Status: Not yet enrolling

Conditions: Muscle Strength; Muscle Weakness

Treatments: Device: Sham Patch without VTT; Device: VICTORY PATCH

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06430879

POWER-UP 001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

100 participants in 3 patient groups

Active/Treatment

Active Comparator group

Description:

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.

Treatment:

Device: VICTORY PATCH

Non-Active/Control

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Patch without VTT

Crossover

Other group

Description:

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.

Treatment:

Device: VICTORY PATCH

Device: Sham Patch without VTT