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Active Limb Orthosis for Home-Use Stroke Hemiparetic Gait Rehabilitation

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.
 
ClinicalTrials.gov Identifier: NCT03649217
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Moterum Technologies Inc.
Information provided by (Responsible Party):
University of South Florida

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Device: wearing the iStride device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Active Limb Orthosis for Home-Use Stroke Hemiparetic Gait Rehabilitation
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: 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.
Device: wearing the iStride device
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.




Primary Outcome Measures :
  1. Change in Percentage change in step length asymmetry [ Time Frame: Baseline assessment at start, within one day of last training session, one month followup, and three month followup. ]
    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 Gait Up Physilog sensor, a ProtoKinetics Zeno Walkway, and/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 follow-up tests.

  2. Change in Percentage change in double support asymmetry [ Time Frame: Baseline assessment at start, within one day of last training session, one month followup, and three month followup. ]
    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 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 and on the 1 and 3 month follow-ups.

  3. Change in Ten minute walk test (10MWT) [ Time Frame: Baseline assessment at start, within one day of last training session, one month followup, and three month followup. ]
    This test is to also help determine gait velocity/speed.

  4. Change in Timed up and Go (TUG) [ Time Frame: Baseline assessment at start, within one day of last training session, one month followup, and three month followup. ]
    This will provide a clinical assessment on gait speed/velocity. This also requires both static and dynamic balance as the participant will rise from a chair and sit down in a chair when the complete the test. The TUG test provides us different score assessments to help determine if a patient can, for example, cross a crosswalk safely.


Secondary Outcome Measures :
  1. Change in Berg Balance Scale [ Time Frame: Baseline assessment at start, within one day of last training session, one month followup, and three month followup. ]
    This will provide a clinical assessment on balance. Score of 56 is the highest. We will be able to determine improvement based on their raw score each time the test is administered.

  2. Change in Functional Gait Assessment (FGA) [ Time Frame: Baseline assessment at start, within one day of last training session, one month followup, and three month followup. ]
    The FGA measures both balance and walking ability with a maximum score of 30. We will use a disease specific, ex. Stroke, statistical breakdown to determine if the patient improved or not, and if it is deemed clinically significant.

  3. Change in Stroke Specific Quality of Life [ Time Frame: Baseline assessment at start, within one day of last training session, one month followup, and three month followup. ]
    Stroke Specific Quality of Life will collect data on the psychosocial aspect of improvement to help look at the overall quality of life. Details of the scale can be found at http://www.strokecenter.org/wp-content/uploads/2011/07/Stroke-Specific-Quality-of-Life-Scale.pdf



Information from the National Library of Medicine

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

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): NCT03649217


Locations
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United States, Florida
University of South Florida Active, not recruiting
Tampa, Florida, United States, 33612
United States, North Carolina
homes throughout Charlotte, NC Recruiting
Charlotte, North Carolina, United States, 28105
Contact: Lauren Rashford, PT    315-335-9622    lauren@moterumtechnologies.com   
United States, Tennessee
homes throughout Memphis, TN Recruiting
Memphis, Tennessee, United States, 37501
Contact: Lauren Rashford, PT    315-335-9622    lauren@moterumtechnologies.com   
United States, Vermont
homes throughout Burlington, VT Recruiting
Burlington, Vermont, United States, 05401
Contact: Lauren Rashford, PT    315-335-9622    lauren@moterumtechnologies.com   
Sponsors and Collaborators
University of South Florida
Moterum Technologies Inc.

Additional Information:
Publications:
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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT03649217    
Other Study ID Numbers: Moterum-iStride
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases