Gait Modification Treatments for Knee Pathology

Stanford University

Status: Completed

Conditions: Knee Injuries; Knee Osteoarthritis

Treatments: Device: Knee Sleeve; Device: Cutaneous Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03116230

40688

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Experimental Treatment A then B

Experimental group

Description:

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.

Treatment:

Device: Knee Sleeve

Device: Cutaneous Stimulation

Experimental Treatment B then A

Experimental group

Description:

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.

Treatment:

Device: Knee Sleeve

Device: Cutaneous Stimulation