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Completed

NCT Number: NCT03116230

Gait Modification Treatments for Knee Pathology

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.

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Key information

Conditions

Knee Injuries Arthritis Joint Diseases Knee Osteoarthritis Leg Injuries Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases Wounds and Injuries

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: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

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.

Knee sleeve

Device

Commercially-available knee sleeve.

Primary outcomes

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

    Time frame: Baseline and 4 week follow-up

    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.

Secondary outcomes

  1. Change in Pain

    Time frame: Baseline and 4 week follow-up

    Within-subject change (follow-up - baseline) in pain (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.

  2. Change in Function

    Time frame: Baseline and 4 week follow-up

    Within-subject change (follow-up - baseline) in function (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.

  3. Change in Symptoms

    Time frame: Baseline and 4-week follow-up

    Within-subject change (follow-up - baseline) in symptoms (KOOS sub-scale) with the intervention at 4-weeks versus control (without the intervention) at baseline. KOOS scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Analysis of Pain, Function, and Joint Mechanics in Response to Two Treatments for Knee Pathology

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 17, 2017
Registry last updated
Aug 17, 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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