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Gait Enhancing Mobile Shoe for Stroke Rehabilitation

This study is currently recruiting participants.
Verified November 2016 by University of South Florida
Sponsor:
ClinicalTrials.gov Identifier:
NCT02185404
First Posted: July 9, 2014
Last Update Posted: November 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Moterum, LLC
Information provided by (Responsible Party):
University of South Florida
  Purpose
The objective of this research is to test a passive shoe capable of to test the capability of a mobile shoe to enhance gait improvements in individuals with asymmetric walking patterns. 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 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.

Condition Intervention
Stroke Device: wearing the GEMS

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Percentage change in step length asymmetry [ Time Frame: Baseline assessment at start and one-month and three-month followups ]
    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 differences during baseline, at the beginning of training, during training, and after training. Step length asymmetry is a standard accepted measure for measuring gait asymmetry. To measure the gait, a ProtoKinetics Zeno Walkway (ProtoKinetics, Havertown, PA) 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 and on the 1 and 3 month follow-ups.

  • Percentage change in double support asymmetry [ Time Frame: Baseline assessment at start and one-month and three-month followups ]
    We will quantify the amount of adaptation and the change in gait asymmetry by comparing the magnitude of double support differences during baseline, at the beginning of training, during training, and after training. 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 ProtoKinetics Zeno Walkway (ProtoKinetics, Havertown, PA) 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 and on the 1 and 3 month follow-ups.


Estimated Enrollment: 5
Study Start Date: April 2015
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: wearing the GEMS
The long-term training will consist of four weeks of training with three training sessions performed each week. The training sessions will consist of up to forty minutes of training over up to eight shorter sessions of walking on the GEMS with breaks between walking sessions and as needed if the subject requests an additional break. Subjects will place the GEMS 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. For split-belt treadmill sessions, the format will be exactly the same, but they will walk on a split-belt treadmill instead of the GEMS with the faster tread moving on the same foot that would wear the GEMS in the over-ground walking sessions.
Device: wearing the GEMS
The GEMS 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 GEMS 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. While the movements of the GEMS are similar to the split belt treadmill, and the GEMS generates a similar aftereffect, the efficacy of this shoe in modifying the gait of an individual with stroke is not yet verified. This research aims to test the GEMS on individuals with stroke to determine if the related effects that show up on healthy subjects can benefit individuals with stroke.

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  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • first-time unilateral cerebral stroke
  • a stroke at least 6 months prior to enrollment
  • gait asymmetry, but able to walk independently
  • no evidence of uncompensated hemianopsia, tested by using Pedretti's method (Pedretti 1985)
  • no evidence of severe (greater than 16 in the Folstein Mini-Mental Status Exam) cognitive impairment (Folstein et al. 1975) or language dysfunction that would interfere with understanding the instructions
  • no evidence of neglect, tested by being asked to copy a simple drawing of a house (Gregory and Aitkin 1971)

Exclusion Criteria:

  • unable to walk at least 0.3m/s
  • orthopedic or pain conditions
  • history of seizure disorders
  • metal implants (stents, clips, pacemaker)
  • pregnancy
  • any condition that makes balance unstable
  • require a walker to walk
  • uncorrected visual impairments
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02185404


Contacts
Contact: Kyle B Reed, Ph.D. 813-974-2385 kylereed@usf.edu

Locations
United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Sponsors and Collaborators
University of South Florida
Moterum, LLC
Investigators
Principal Investigator: Kyle B Reed, Ph.D. University of South Florida
  More Information

Additional Information:
Publications:
Kim S, Handzic I, Huizenga D, Edgeworth R, Lozinski M, Ramakrishnan T, & Reed KB," Initial Results of the Gait Enhancing Mobile Shoe on Individuals with Stroke" 38th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC), August 2016.

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT02185404     History of Changes
Other Study ID Numbers: Moterum-GEMS-1
First Submitted: June 27, 2014
First Posted: July 9, 2014
Last Update Posted: November 10, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases