Trial Outcomes & Findings for Gait Modifications and Cutaneous Stimulation (NCT NCT02884414)

Last Updated: 2021-01-08

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

56 participants

Primary outcome timeframe

Immediate

Results posted on

2021-01-08

Participant milestones
Measure	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.
Overall Study STARTED	56
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Data excluded from n=3 participants due to technical data collection issue.

Baseline characteristics by cohort
Measure	Cutaneous Stimulation n=56 Participants 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.
Age, Continuous	47.8 years STANDARD_DEVIATION 18.5 • n=56 Participants
Sex: Female, Male Female	26 Participants n=56 Participants
Sex: Female, Male Male	30 Participants n=56 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=56 Participants
Race (NIH/OMB) Asian	17 Participants n=56 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=56 Participants
Race (NIH/OMB) Black or African American	2 Participants n=56 Participants
Race (NIH/OMB) White	36 Participants n=56 Participants
Race (NIH/OMB) More than one race	1 Participants n=56 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=56 Participants
Region of Enrollment United States	56 participants n=56 Participants
Knee Flexion Moment	2.68 %Bw*Ht STANDARD_DEVIATION 1.29 • n=53 Participants • Data excluded from n=3 participants due to technical data collection issue.

Timeframe: Immediate

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

Outcome measures
Measure	Cutaneous Stimulation n=53 Participants 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.
Change in Peak Knee Flexion Moment (%Bw*Ht)	2.72 %Bw*Ht Standard Deviation 1.25

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Stanford University

Phone: 650-493-5000