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N/A N=6 Treatment

iStride(TM) Device Used for Stroke Rehabilitation

Stroke

Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Percentage Change in Step Length Asymmetry — 11.6 % change in asymmetry

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
wearing the iStride device (Device)
Age
Adult, Older Adult · 21+ yrs
Sex
All
Sponsor
University of South Florida
Primary completion
Dec 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage Change in Step Length Asymmetry
11.6
PRIMARY
Percentage Change in Double Support Asymmetry
-3.9

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. 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.

Eligibility Criteria

Inclusion Criteria

  • age 21-80
  • one or more cerebral strokes, but all strokes on same side
  • a stroke at least 6 months prior to enrollment
  • Gait asymmetry, but able to walk independently with or without a cane
  • Not currently receiving physical therapy
  • no evidence of severe cognitive impairment that would interfere with understanding the instructions
  • no evidence of one-sided neglect, affecting ambulation
  • At least 25 feet of walking space in home (does not need to be a straight line)
  • Weight does not exceed 250 lbs

Exclusion Criteria

  • uncontrolled seizures
  • metal implants (stents, clips, pacemaker)
  • pregnancy
  • History of a neurological disorder other than stroke ( Parkinson's, MS)
  • Chronic Obstructive Pulmonary Disease
  • Uncontrolled blood pressure
  • Head injury in the past 90 days
  • A myocardial infarction within the last 180 days
  • Cannot rely on a rolling walker for ambulation
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02185404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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