N/A
N=23
Active Limb Orthosis for Home-Use Stroke Hemiparetic Gait Rehabilitation
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT03649217 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: Change in Ten Minute Walk Test (10MWT) — 0.551 meters per second (m/s) — p=.0001
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 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Ten Minute Walk Test (10MWT) |
0.551 | .0001 sig |
| PRIMARY Change in Timed up and Go (TUG) |
19.2 | .0001 sig |
| SECONDARY Change in Berg Balance Scale |
43.52 | .001 sig |
| SECONDARY Change in Functional Gait Assessment (FGA) |
15 | .0002 sig |
| SECONDARY Change in Stroke Specific Quality of Life |
165.05 | .006 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT03649217). 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.