Gait Modification Treatments for Knee Pathology

NCT03116230 | Completed Results

• 1 other identifier: 40688
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is complete a longitudinal cross-over clinical study to investigate the effect of treatments for knee pathology, including cutaneous stimulation (skin vibration and soft knee brace), on locomotion tasks (i.e. walking, jogging, stair ascending and descending), muscle function, and pain/function.

Conditions

Knee Injuries; Knee Osteoarthritis

Keywords

Knee pathology

Outcome Measures

Primary Outcomes (1)

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

  Within-subject change (follow-up - baseline) in peak knee flexion moment (%Bodyweight\*Height) with the intervention at 4-week follow-up versus control (without the intervention) at baseline.

  Baseline and 4 week follow-up

Secondary Outcomes (3)

• Change in Pain

  Baseline and 4 week follow-up

• Change in Function

  Baseline and 4 week follow-up

• Change in Symptoms

  Baseline and 4-week follow-up

Study Arms (2)

Experimental Treatment A then B

EXPERIMENTAL

Subjects will receive two treatments: (1) a non-invasive external Cutaneous Stimulation device placed on the leg of the subject consisting 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 (vibration) to the subject and (2) a commercially-available knee sleeve, separated by a washout period.

Device: Cutaneous Stimulation; Device: Knee Sleeve

Experimental Treatment B then A

EXPERIMENTAL

Subjects will receive two treatments: (1) a commercially-available knee sleeve and (2) a non-invasive external Cutaneous Stimulation device placed on the leg of the subject consisting 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 (vibration) to the subject, separated by a washout period.

Device: Cutaneous Stimulation; Device: Knee Sleeve

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.

Experimental Treatment A then B; Experimental Treatment B then A

Knee Sleeve DEVICE

Commercially-available knee sleeve.

Experimental Treatment A then B; Experimental Treatment B then A

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80
• Ambulatory
• Symptomatic knee pain ≥ 3/10 on most of the past 30 days
• Prior ACL injury/surgery, meniscus injury/surgery, and/or physician-diagnosed medial compartment knee osteoarthritis (KL grade 1-3)
• Agreement and ability to use provided interventions during the study period (suggested cumulative wear time during walking of 1-2 hr/day)
• Committed to not starting any new therapies for knee condition during the trial, other than rescue pain medication.

You may not qualify if:

• Use of walking aid (e.g. cane, crutch, walker, or wheelchair)
• BMI ≥ 35 kg/m2
• Injection in the affected knee during the previous three months
• Known neuropathy due to diabetes or other causes
• Inability to provide informed consent

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Knee Injuries; Osteoarthritis, Knee

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; 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: Thomas Andriacchi
• Organization: Stanford University

tandriac@stanford.edu

650-

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: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be told only that we are comparing two types of treatment for their knee pain.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 17, 2017
• Study Start: January 15, 2018
• Primary Completion: January 22, 2019
• Study Completion: January 22, 2019
• Last Updated: August 17, 2021
• Results First Posted: August 17, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)