Clinical trial NCT06430879: Performance Output With Haptics - Evaluating Athlete Response and Unrealized Potential
Official title: POWER-UP Trial (Performance Output With Haptics - Evaluating Athlete Response and Unrealized Potential)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Muscle Strength
Muscle Weakness
Keywords: muscle
quadriceps
hamstrings
college athletes
elite athletes
haptic technology
vibrotactile trigger technology
VTT
neuromuscular changes
Lead sponsor: SuperPatch Limited LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Arizona
name: Clarity Science LLC
First posted: 2024-05-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blind, placebo controlled, crossover trial with functional measurements
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in subject performance and strength and intensity/interference scores among and between the treated group and the control group for the athlete.
timeFrame: 10 days
measure: Changes in subject performance and strength and intensity/interference scores among and between the treated group and the control group for the athlete.
timeFrame: 10 days
measure: Changes in subject performance and strength and intensity/interference scores among and between the treated group and the control group for the athlete.
timeFrame: 10 days
measure: Changes in subject performance and strength and intensity/interference scores among and between the treated group and the control group for the athlete.
timeFrame: 10 days
measure: Changes in performance based on patch location or playing position with the VICTORY Patch treatment.
timeFrame: 10 days
Secondary outcomes:
measure: 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.
timeFrame: 10 days
Other outcomes:
measure: Any side effects reported by patients with be documented in athletic training electronic medical record and assessed by team physician and PI
timeFrame: 10 days
Locations:
Study officials:
affiliation: University of Arizona
name: Mark Sakr, DO
role: PRINCIPAL_INVESTIGATOR
References: