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StrokeNCT03649217

Active Limb Orthosis for Home-Use Stroke Hemiparetic Gait Rehabilitation

A study testing wearing the iStride device in people with Stroke, run by University of South Florida at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Stroke
What is being tested?
wearing the iStride device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
4 sitesUnited States
Study dates
9 Jul 2018to 9 Dec 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Head injury in the past 90 days
  • A myocardial infarction within the last 180 days
  • Cannot rely on a rolling walker for ambulation

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • homes throughout Burlington, VT

    Burlington, Vermont, 05401

  • homes throughout Charlotte, NC

    Charlotte, North Carolina, 28105

  • homes throughout Memphis, TN

    Memphis, Tennessee, 37501

  • University of South Florida

    Tampa, Florida, 33612

Other trials in United States

About this study

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.

Read the detailed description

Hemiparesis and other impairments are a frequent and disabling consequence of stroke and can lead to asymmetric and inefficient walking patterns. Training on a split-belt treadmill, which has two separate treads driving each leg at a different speed, can correct gait asymmetries post-stroke. However, the effects of split-belt treadmill training only partially transfer to everyday walking over ground and extended training sessions are required to achieve long-lasting effects. Our previous studies suggest that the iStride device that has been developed in our laboratory can be used as an alternative gait training device for people with stroke. The iStride 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. The iStride 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. While the movements of the iStride device are similar to the split belt treadmill, and the iStride device 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 continue to test the iStride device on individuals with stroke to determine if the related effects in a clinic setting, are also beneficial and safe in a home environment.

In this study, we will test the efficacy of the iStride device on individuals with stroke in the clinic and within their own home. Efficacy will be evaluated based on the change in gait coordination and also based on subjects' self-reported comfort on the device. We predict that the iStride device will result in changes to interlimb coordination of gait and prove to be a safe and effective device to be used in ones' home.

The asymmetric nature of hemiparetic gait can have a large impact on functional walking ability. For example, swing phase asymmetry is a significant predictor of hemiparetic walking performance because it strongly correlates with stages of motor recovery, walking speed, and falls. Another measure of temporal asymmetry - double support duration - is similarly correlated with walking speed. In addition, spatial (e.g. step length) asymmetry is associated with decreased propulsive force on the paretic leg, which limits forward motion of the body and reduces gait efficiency. The importance of gait efficiency should not be understated - the elevated energy demands of hemiparetic gait combined with physical deconditioning post-stroke can greatly limit performance of activities of daily living, contributing to poor cardiovascular fitness and metabolic syndrome. In turn, this can increase the risks of a second stroke or cardiovascular event and is associated with increased morbidity and mortality rates. Therefore, improving gait symmetry should be an important goal for therapy, to not only improve functional mobility and reduce injury, but also to enhance general health and well-being post-stroke.

Practicing walking on a split-belt treadmill can correct abnormal interlimb coordination of gait in individuals with hemiparesis following stroke or other central nervous system lesions. Asymmetric gait can manifest as a spatial asymmetry, in which steps taken on one side are longer than those on the other. It can also manifest as a temporal asymmetry, where the timing is uneven on the paretic and non-paretic sides. Temporal asymmetries are often measured as differences in the duration of double support periods, which are the amount of time both feet are simultaneously contacting the ground and are measured separately for the paretic and non-paretic sides. The iStride device is designed to cause changes in both spatial and temporal gait symmetry. We predict that the iStride device would cause the steps on the side with the iStride device to be larger since individuals would compensate for the backward rolling motion by placing their foot farther forward in stance, thus increasing the distance between the two feet. Similarly, since the stride is longer, it may also shorten the duration of stance relative to the other side. With shortened stance duration, the amount of time spent in double-support at the end of stance would likely decrease as well.

Although the original idea of the iStride device is derived from the motion of the split-belt-treadmill, there are distinct differences between walking on the device and walking on a split-belt treadmill with asymmetric belt velocities. While the body's velocity relative to ground is zero on a split-belt treadmill, the relative velocity of the iStride device is non-zero and forward. The device forces the wearer's foot forward or backward whereas the treadmill moves both feet backward, but at different speeds. For both the split-belt treadmill and the iStride device, the relative velocity between both feet is similar and the backward-moving iStride device takes the place of the faster tread.

We hypothesize that training over ground will lead to a change in the interlimb coordination in individuals with asymmetric gait and allow individuals to develop a more persistent symmetric gait. There are several differences between training on ground and a treadmill, such as visual flow and vestibular information signaling forward movement that likely limit the expression of learning in the over-ground context when trained on a treadmill. Visual cues appear to be particularly important for context awareness. Visual cues, coupled with prior experience, are so powerful that predictive postural responses cause an individual to stumble when stepping onto an escalator that is not moving. The body has learned an internal model that expects an acceleration when stepping onto an escalator, but when that acceleration does not occur, the person stumbles. A study of split-belt walking showed that transfer to over-ground walking is enhanced when subjects are blindfolded during training on the treadmill and tested over ground. Since blindfolding eliminates visual cues about the environment, this also suggests that vision is a key factor in determining the context-dependence of learning. Since it is not realistic to blindfold stroke patients during gait training, we designed the iStride device so that training could occur during over-ground walking, thus visual cues during training and later walking over ground would be the same.

Data from control subjects using an earlier version of the iStride device (referred to as GEMS at the time) has been published and a video of this previous version can be found at http://reedlab.eng.usf.edu/publications/handzic2011GEMS.mp4. In this study, we found that this earlier version of the device was capable of changing step length as predicted, however the previous design was too heavy and too tall to be considered practical for testing in stroke populations. The current version of the iStride device produces similar motion to the previous version, but it weighs less (under 1 kg) and is shorter (~4.4 cm). We will test the efficacy of wearing the current iStride device on gait coordination during walking over ground on individuals with stroke in the clinic and within their own home. All walking will be performed while subjects are closely guarded by an experienced physical therapist to prevent falling. The effects of the iStride device on gait coordination will be compared to those induced on a split-belt treadmill.

The proposed project represents one of the first attempts to build a device that corrects walking symmetry while walking over ground. Not only would this allow people to experience gait corrections while performing normal movements, but the simplicity and relative low cost of these devices would also open up potential opportunities to train at home (for high-functioning individuals with supervision) and in clinics where a split-belt treadmill is not available. The studies outlined here will establish whether the iStride device is capable of changing interlimb coordination of gait, and whether individuals with stroke can use these devices for rehabilitation purposes. This work will thus build the foundation for future training studies examining the effectiveness of long-term use of the iStride device for improving symmetric walking patterns.

The question that this study targets is the modification of human walking patterns for use in stroke rehabilitation. It is our ultimate objective to show that the iStride device can change a person's temporal and spatial gait asymmetry into a symmetric gait. We have demonstrated this in a clinic setting, and now we will test the device within the participants own home. Our points of reference are results obtained by previous studies with split-belt treadmills. We are also interested in how altering the interface between a foot and the ground influences the adaptation to new walking patterns.

Conditions
Stroke
Being tested
wearing the iStride device
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • wearing the iStride deviceDevice

    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.

Study groups in NCT03649217
Study groupRoleWhat they receive
wearing the iStride deviceExperimentalThe 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.
Receives: Device: wearing the iStride device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Ten Minute Walk Test (10MWT)

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

    Measured: Difference between baseline assessment at start and one week post

  2. 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.

    Measured: Difference between baseline assessment at start and one week post

Secondary outcomes (3)
  1. Change in Berg Balance Scale

    This will provide a clinical assessment on balance using the total Berg Balance Scale. Scores range from 0 (least balance) to 56 (best balance).

    Measured: Difference between baseline assessment at start and one week post

  2. Change in Functional Gait Assessment (FGA)

    The FGA measures both balance and walking ability with scores ranging from 0 (least ability) to 30 (highest ability).

    Measured: Difference between baseline assessment at start and one week post

  3. Change in Stroke Specific Quality of Life

    Stroke Specific Quality of Life will collect data on the psychosocial aspect of improvement to help look at the overall quality of life. The total score ranges from 49 to 245, with higher scores indicating a better quality of life.

    Measured: Difference between baseline assessment at start and one week post

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2018
  2. Study start9 Jul 2018
  3. Primary completion9 Dec 2019
  4. Study completion9 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03649217
Sponsor's protocol ID
Moterum-iStride
Status last verified
Aug 2020
First submitted
6 Aug 2018
Last updated
3 Feb 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 24371521
  • 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.

    PubMed 23484067
  • Kim S, Handzic I, Huizenga D, Edgeworth R, Lozinski M, Ramakrishnan T, & Reed KB,

  • 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.

    PubMed 24187324
  • 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.

    PubMed 31455358
  • 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.

    PubMed 38274885

Questions about this trial

What is this clinical trial studying?

A study testing wearing the iStride device in people with Stroke, run by University of South Florida at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Ten Minute Walk Test (10MWT) (time frame: Difference between baseline assessment at start and one week post). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03649217, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.

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