Trial Outcomes & Findings for iStride(TM) Device Used for Stroke Rehabilitation (NCT NCT02185404)

Last Updated: 2021-09-22

Results Overview

During a symmetric gait, step lengths on each side are the same; during an asymmetric gait, step lengths are different. We will quantify the amount of adaptation and the change in gait asymmetry by comparing the magnitude of step length difference between baseline and after four weeks of training (three training sessions per week). Step length asymmetry is a standard accepted measure for measuring gait asymmetry. To measure the gait, a Gait Up Physilog sensor, a ProtoKinetics Zeno Walkway, or a motion capture system will be used. The analysis will be conducted using a repeated measures ANOVA to compare baseline gait symmetry at the start of the experiment to post-adaptation at the end of the experiment.

Recruitment status

COMPLETED

Study phase

Target enrollment

6 participants

Primary outcome timeframe

Baseline assessment at start and at conclusion of training

Results posted on

2021-09-22

Participant Flow

Participant milestones

Participant milestones
Measure	Wearing the iStride Device The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their foot in which they have the shortest step length, as measured during the pre-training gait analysis. This is typically the healthy side foot. There will also be several follow up visits following the final testing session.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

iStride(TM) Device Used for Stroke Rehabilitation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Wearing the iStride Device n=6 Participants The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their foot in which they have the shortest step length, as measured during the pre-training gait analysis. This is typically the healthy side foot. There will also be several follow up visits following the final testing session.
Age, Continuous	65.7 years STANDARD_DEVIATION 6.9 • n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=93 Participants
Years Post Stroke	6.8 years STANDARD_DEVIATION 4.2 • n=93 Participants

PRIMARY outcome

Timeframe: Baseline assessment at start and at conclusion of training

Outcome measures

Outcome measures
Measure	Wearing the iStride Device n=6 Participants The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their foot in which they have the shortest step length, as measured during the pre-training gait analysis. This is typically the healthy side foot. There will also be several follow up visits following the final testing session.
Percentage Change in Step Length Asymmetry	11.6 % change in asymmetry Standard Deviation 10.4

PRIMARY outcome

Timeframe: Baseline assessment at start and at conclusion of training

We will quantify the amount of adaptation and the change in gait asymmetry by comparing the magnitude of double support difference between baseline and after four weeks of training (three training sessions per week). During a symmetric gait, double support is the same; during an asymmetric gait, double support is different. Double support asymmetry is a standard accepted measure for measuring gait asymmetry. To measure the gait, a Gait Up Physilog sensor, a ProtoKinetics Zeno Walkway, or a motion capture system will be used. The analysis will be conducted using a repeated measures ANOVA to compare baseline gait symmetry at the start of the experiment to post-adaptation at the end of the experiment.

Outcome measures

Outcome measures
Measure	Wearing the iStride Device n=6 Participants The training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to thirty minutes of training with the iStride on, with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the device on their foot in which they have the shortest step length, as measured during the pre-training gait analysis. This is typically the healthy side foot. There will also be several follow up visits following the final testing session.
Percentage Change in Double Support Asymmetry	-3.9 % change in asymmetry Standard Deviation 9.56

Adverse Events

Wearing the iStride Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kyle B. Reed

University of South Florida

Phone: 813-974-2385

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place