CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 enrolled
Drug / intervention
wearing the iStride devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03649217
NCT03649217N/ACompleted

Active Limb Orthosis for Home-Use Stroke Hemiparetic Gait Rehabilitation

University of South Florida·interventional·Posted Aug 28, 2018·Updated Feb 3, 2022

In Brief

A clinical study evaluating wearing the iStride device for Stroke. Completed, enrolled 23 participants across 4 sites.

Detailed Summary

The objective of this research is to test a passive shoe to correct gait in individuals with asymmetric walking patterns. This will be done in a clinic and within their own home. Individuals with central nervous system damage, such as stroke, often have irregular walking patterns and have difficulty walking correctly. Recent research has shown that using a split-belt treadmill can create after-effects that temporarily correct the inefficient walking patterns. However, the corrected walking pattern does not efficiently transfer from the treadmill to walking over ground. The iStride, formerly known as the Gait Enhancing Mobile Shoe (GEMS), may allow a patient to practice walking in many different locations, such as their own home, which we hypothesize will result in a more permanent transfer of learned gait patterns. To enable long-term use, our proposed shoe design is passive and uses the wearer's natural forces exerted while walking to generate the necessary motions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStroke
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 28, 2018
Enrollment StartJul 9, 2018
Primary CompletionDec 9, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.8 years ago

Interventions

wearing the iStride devicedevice

The device mimics the actions of the split-belt treadmill, but can be used during over-ground walking and in one's own home, thus enabling long-term training. This device does not require any external power and is completely passive; all necessary forces are redirected from the natural forces present during walking since it utilizes the wearer's weight to generate its movements. This research aims to test the iStride on individuals with stroke in their own home in order to determine if the related effects that we saw in the clinic, can also benefit patients at home.