Gait Modifications and Cutaneous Stimulation

NCT ID: NCT02884414

Last Updated: 2021-01-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-31

Study Completion Date

2019-02-28

Brief Summary

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The purpose of this study is to quantify differences in joint mechanics between different types of walking in healthy individuals and individuals with knee pathology. The investigators will determine how modifying gait through feedback and/or cutaneous stimulation changes joint loading.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cutaneous Stimulation

Cutaneous stimulation and/or feedback. This stimulation and/or feedback may be visual, auditory, tactile (e.g. vibratory, temperature), or haptic and is completely external.

Group Type EXPERIMENTAL

Cutaneous stimulation

Intervention Type DEVICE

A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.

Interventions

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Cutaneous stimulation

A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* BMI \< 35 kg/m\^2
* For knee pathology subjects: Diagnosis of knee pathology (e.g. knee osteoarthritis, ACL injury, etc) and/or knee pain
* Full weight-bearing status

Exclusion Criteria

* Non-ambulatory
* Use of walking aid
* For healthy volunteers - history of surgical intervention at any joint of the lower extremity
* Inability to cooperate with study protocol due to medical or psychiatric reasons
* Inability to provide informed consent
* For healthy subjects: Any diagnosis of knee osteoarthritis or knee pain
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Thomas Peter Andriacchi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Andriacchi, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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37562

Identifier Type: -

Identifier Source: org_study_id

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