Gait Modifications and Cutaneous Stimulation

NCT02884414 | Completed Results

• 1 other identifier: 37562
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Knee

Keywords

Knee Pathology

Outcome Measures

Primary Outcomes (1)

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

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

  Immediate

Study Arms (1)

Cutaneous Stimulation

EXPERIMENTAL

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.

Device: Cutaneous stimulation

Interventions

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.

Cutaneous Stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Jennifer Hledik
• Organization: Stanford University

jerhart@stanford.edu

650-493-5000

Study Officials

• Thomas Andriacchi, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: August 31, 2016
• Study Start: August 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: January 8, 2021
• Results First Posted: January 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)