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OpenTrials
Completed

NCT Number: NCT02884414

Gait Modifications and Cutaneous Stimulation

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cutaneous Stimulation

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.

Primary outcomes

  1. Change in Peak Knee Flexion Moment (%Bw*Ht)

    Time frame: Immediate

    Within-subject change in peak knee flexion moment (%Bodyweight*Height) with the intervention versus control (without the intervention).

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Analysis of Joint Mechanics in Response to Gait Modifications and Cutaneous Stimulation

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 31, 2016
Registry last updated
Jan 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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