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Evaluating Non-Invasive Haptics During Extreme Exercise

NCT ID: NCT07285252

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-05

Study Completion Date

2026-09-30

Brief Summary

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This study aims to compare determinants of endurance performance between participants wearing an active patch with haptic vibrotactile trigger technology (VTT) versus a placebo patch without VTT among recreational to competitive runners over a 4-week training period.

Detailed Description

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Conditions

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VO2max Lactate Threshold Lactate

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

A prospective, non-randomised, double-blinded, parallel-group internal pilot study evaluating the acceptability, safety, recruitment processes, data-collection procedures, and preliminary performance signals of the SuperPatch VICTORY vibrotactile patch in recreational-competitive runners. The Study was designed to inform a future fully-powered interventional study. The study follows the CONSORT Extension for Pilot and Feasibility Trials. The study involves comparison of data from two parallel groups: (1) an active intervention group using SuperPatch VICTORY Patch (intervention) versus (2) a placebo group using a visually identical patch lacking the vibrotactile neurosensory pattern. Participants will be followed for four weeks with lab-based assessments at baseline (Week 0), Week 2, and Week 4.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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TREATMENT

Victory Patch

Group Type ACTIVE_COMPARATOR

Victory Patch with Haptic Vibrotactile Trigger Technology

Intervention Type DEVICE

Active Patch with Haptic Vibrotactile Trigger Technology

CONTROL

Sham Comparator

Group Type PLACEBO_COMPARATOR

Sham patch

Intervention Type DEVICE

Sham/Placebo Patch without Haptic Vibrotactile Trigger Technology

Interventions

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Victory Patch with Haptic Vibrotactile Trigger Technology

Active Patch with Haptic Vibrotactile Trigger Technology

Intervention Type DEVICE

Sham patch

Sham/Placebo Patch without Haptic Vibrotactile Trigger Technology

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adults aged 18 years and over, that participate in recreational to competitive distance running (\>2 structured runs per week), that were able to complete maximal treadmill exercise safely and were able to attend three laboratory visits were invited to participate.

Exclusion Criteria

* Adults with a contraindications to high-intensity treadmill exercise, cardiovascular, metabolic, or musculoskeletal conditions limiting participation, reported use of performance-enhancing drugs, pregnancy, known allergy to adhesives, or current use of neuromodulatory or haptic devices
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clarity Science LLC

UNKNOWN

Sponsor Role collaborator

The Altitude Centre

UNKNOWN

Sponsor Role collaborator

Vichag Healthcare Research

UNKNOWN

Sponsor Role collaborator

SuperPatch Limited LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Sakr, DO

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

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The Altitude Centre

London, UK, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ENDURE-001

Identifier Type: -

Identifier Source: org_study_id