Osteoarthritis, Knee
Conditions
Keywords
Knee Pathology
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.
Interventions
DEVICECutaneous stimulation
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.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Peak Knee Flexion Moment (%Bw*Ht) | Immediate | Within-subject change in peak knee flexion moment (%Bodyweight\*Height) with the intervention versus control (without the intervention). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cutaneous Stimulation 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.
Cutaneous stimulation: 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. | 56 |
| Total | 56 |
Baseline characteristics
| Characteristic | Cutaneous Stimulation |
|---|---|
| Age, Continuous | 47.8 years STANDARD_DEVIATION 18.5 |
| Knee Flexion Moment | 2.68 %Bw*Ht STANDARD_DEVIATION 1.29 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 17 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 36 Participants |
| Region of Enrollment United States | 56 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 56 |
| other Total, other adverse events | 0 / 56 |
| serious Total, serious adverse events | 0 / 56 |
Outcome results
Primary
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).
Time frame: Immediate
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cutaneous Stimulation | Change in Peak Knee Flexion Moment (%Bw*Ht) | 2.72 %Bw*Ht | Standard Deviation 1.25 |
p-value: 0.44t-test, 2 sided