Performance Output With Haptics - Evaluating Athlete Response and Unrealized Potential

Muscle Weakness Clinical Trial

— POWER-UP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06430879
• Other study ID #: POWER-UP 001
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 10, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2024
• Source: SuperPatch Limited LLC
• Contact: Peter Hurwitz
• Phone: 9177570521
• Email: peterh[@]claritysciences.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Strength
• Muscle Weakness

Intervention

Device:
• VICTORY PATCH
Drug- free, non-invasive patch (VICTORY Patch) with haptic vibrotactile trigger technology (VTT)
• Sham Patch without VTT
Sham Patch without haptic vibrotactile trigger technology (VTT)

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
SuperPatch Limited LLC	Clarity Science LLC, University of Arizona

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Any side effects reported by patients with be documented in athletic training electronic medical record and assessed by team physician and PI	Evaluation of reported side effects during study period based on self-report by subject or reported by clinician investigator.	10 days
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	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