Active Limb Orthosis for Home-Use Stroke Hemiparetic Gait Rehabilitation

NCT03649217 | Completed Results FDA Device

• 1 other identifier: Moterum-iStride
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• Change in Ten Minute Walk Test (10MWT)

  This test is to also help determine gait velocity/speed.

  Difference between baseline assessment at start and one week post

• Change in Timed up and Go (TUG)

  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.

  Difference between baseline assessment at start and one week post

Secondary Outcomes (3)

• Change in Berg Balance Scale

  Difference between baseline assessment at start and one week post

• Change in Functional Gait Assessment (FGA)

  Difference between baseline assessment at start and one week post

• Change in Stroke Specific Quality of Life

  Difference between baseline assessment at start and one week post

Study Arms (1)

wearing the iStride device

EXPERIMENTAL

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

Interventions

wearing the iStride device 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.

wearing the iStride device

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead
• Moterum Technologies, Inc.: collaborator

Study Sites (4)

University of South Florida

Tampa, Florida, 33612, United States

Location

homes throughout Charlotte, NC

Charlotte, North Carolina, 28105, United States

Location

homes throughout Memphis, TN

Memphis, Tennessee, 37501, United States

Location

homes throughout Burlington, VT

Burlington, Vermont, 05401, United States

Location

Related Publications (6)

• Handzic I, Barno EM, Vasudevan EV, Reed KB. Design and Pilot Study of a Gait Enhancing Mobile Shoe. Paladyn. 2011 Dec 1;2(4):10.2478/s13230-012-0010-7. doi: 10.2478/s13230-012-0010-7.

  PMID: 24371521 BACKGROUND

• Handzic I, Vasudevan E, Reed KB. Developing a Gait Enhancing Mobile Shoe to Alter Over-Ground Walking Coordination. IEEE Int Conf Robot Autom. 2012 May;2012:4124-4129. doi: 10.1109/ICRA.2012.6225346.

  PMID: 23484067 BACKGROUND

• Kim S, Handzic I, Huizenga D, Edgeworth R, Lozinski M, Ramakrishnan T, & Reed KB,

  BACKGROUND

• Handzic I, Reed KB. Comparison of the passive dynamics of walking on ground, tied-belt and split-belt treadmills, and via the Gait Enhancing Mobile Shoe (GEMS). IEEE Int Conf Rehabil Robot. 2013 Jun;2013:6650509. doi: 10.1109/ICORR.2013.6650509.

  PMID: 24187324 BACKGROUND

• Kim SH, Huizenga DE, Handzic I, Ditwiler RE, Lazinski M, Ramakrishnan T, Bozeman A, Rose DZ, Reed KB. Relearning functional and symmetric walking after stroke using a wearable device: a feasibility study. J Neuroeng Rehabil. 2019 Aug 28;16(1):106. doi: 10.1186/s12984-019-0569-x.

  PMID: 31455358 BACKGROUND

• Darcy B, Rashford L, Tsai NT, Huizenga D, Reed KB, Bamberg SJM. One-year retention of gait speed improvement in stroke survivors after treatment with a wearable home-use gait device. Front Neurol. 2024 Jan 11;14:1089083. doi: 10.3389/fneur.2023.1089083. eCollection 2023.

  PMID: 38274885 DERIVED

Related Links

• Additional information on a related stroke rehabilitation shoe.
• Commercial information about the iStride(TM) Device

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Brianne Darcy
• Organization: Moterum Technologies, Inc.

brie@moterumtechnologies.com

(864) 659-3180

Study Officials

• Lauren Rashford, PT

  Moterum Technologies, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2018
• First Posted: August 28, 2018
• Study Start: July 9, 2018
• Primary Completion: December 9, 2019
• Study Completion: December 9, 2019
• Last Updated: February 3, 2022
• Results First Posted: February 3, 2022

Record last verified: 2020-08

Locations

US (4)