Performance Output With Haptics - Evaluating Athlete Response and Unrealized Potential

NCT06430879 | Completed

• 1 other identifier: POWER-UP 001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Strength; Muscle Weakness

Keywords

muscle; quadriceps; hamstrings; college athletes; elite athletes; haptic technology; vibrotactile trigger technology; VTT; neuromuscular changes

Outcome Measures

Primary Outcomes (5)

• Changes in subject performance and strength and intensity/interference scores among and between the treated group and the control group for the athlete.

  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.

  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.

  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

• Changes in subject performance and strength and intensity/interference scores among and between the treated group and the control group for the athlete.

  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.

  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

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.

  10 days

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

  10 days

Study Arms (3)

Active/Treatment

ACTIVE COMPARATOR

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

Non-Active/Control

SHAM COMPARATOR

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

Crossover

OTHER

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; Device: Sham Patch without VTT

Interventions

VICTORY PATCH DEVICE

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

Also known as: Haptic Vibrotactile Trigger Technology, VTT

Active/Treatment; Crossover

Sham Patch without VTT DEVICE

Sham Patch without haptic vibrotactile trigger technology (VTT)

Also known as: Sham Comparator

Crossover; Non-Active/Control

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SuperPatch Limited LLC: lead
• University of Arizona: collaborator
• Clarity Science LLC: collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721, United States

Location

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

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

Study Officials

• Mark Sakr, DO

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo controlled, crossover trial with functional measurements

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 28, 2024
• Study Start: July 10, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

US (1)