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临床试验/NCT06430879
NCT06430879已完成不适用

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

SuperPatch Limited LLC2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
2
主要终点
Changes in performance based on patch location or playing position with the VICTORY Patch treatment.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Changes in performance based on patch location or playing position with the VICTORY Patch treatment.

时间窗: 10 days

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.

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

时间窗: 10 days

Evaluation of change in quadriceps and hamstring function via KangaTech measurements (mm/Kg)

次要结局

  • 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)

研究者

发起方
SuperPatch Limited LLC
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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