iStride Device for Gait Difficulty After Stroke

Overseen By Stacy J.M. Bamberg, ScD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Moterum Technologies, Inc.

Disqualifiers: Uncontrolled seizures, Metal implants, Pregnancy, COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with hemiparetic gait impairments (difficulty walking due to one-sided weakness) using a special device called iStride™ (a rehabilitation device), delivered via telemedicine. The study aims to determine if this treatment can be effectively guided and monitored remotely, enabling patients to work with physical therapists from home. Ideal participants have experienced hemiparesis, possibly due to a stroke that occurred over three months ago, and can walk independently, even if they use a cane or similar aid. As an unphased trial, this study offers a unique opportunity to contribute to innovative rehabilitation methods that could enhance remote care for future patients.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that the iStride™ device is safe for gait treatment?

Research shows limited specific safety information for the iStride™ device itself. However, the device aims to help people improve their walking. It is portable, requires no power, and mimics the effects of certain treadmill therapies.

The trial is marked as "Not Applicable" for phase, indicating it explores new ways to deliver treatment, such as telemedicine. This suggests the device might already be considered fairly safe, as trials focusing on new delivery methods often involve treatments known to be safe.

Given the limited detailed safety data, potential participants should discuss any concerns with the trial team and ensure they understand the safety measures in place. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the iStride™ device because it offers a novel way to improve walking abilities in individuals with hemiparetic gait, often seen after a stroke. Unlike traditional physical therapy that requires in-person sessions, the iStride™ device is used remotely via telemedicine. This method not only makes therapy more accessible but also allows for real-time monitoring and adjustments by physical therapists. The device is designed to engage users in repetitive walking exercises that are crucial for neuroplasticity, potentially leading to more significant improvements in gait.

What evidence suggests that the iStride™ device is effective for hemiparetic gait impairments?

Research shows that the iStride™ device can improve walking, particularly for those with stroke-related difficulties. In earlier studies, individuals using the iStride™ device enhanced their balance and walking speed. The device promotes a more balanced and safer walking method. In this trial, participants will receive gait treatment with the iStride™ device via telemedicine. Early findings suggest that using the device through telehealth, which involves receiving healthcare remotely, is both safe and practical. This approach allows patients to benefit from the device without visiting a clinic in person. ^{1 2 3 4 6}

Who Is on the Research Team?

Stephen T. Shultz, PT, DPT, OCS

Principal Investigator

Wingate University

Are You a Good Fit for This Trial?

Inclusion Criteria

Age 21-80

Caregiver support. The caregiver should be an adult over the age of 18 without physical or cognitive limitations which would prohibit them from being able to provide appropriate assistance to the device user

Hemiparesis

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Treatment

Participants receive gait treatment using the iStride™ device via telemedicine, consisting of 12 sessions over 4 weeks

4 weeks

12 sessions (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple intervals

12 months

Assessments at 1-week, 1-month, 3-months, 6-months, and 12-months post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• iStride™ device

How Is the Trial Designed?

Group I: Delivery of iStride™ device gait treatment using telemedicine Experimental Treatment 1 Intervention

Treatment with the gait device will be adapted to remote delivery using the telemedicine platform. Participants and caregivers will be guided through an adapted treatment protocol remotely by physical therapists. Training will include platform navigation, device instruction, treatment guidelines, safety precautions, and assessment performance. Understanding will be verified through a caregiver quiz. Gait patterns will be monitored before, during, and after treatment using gait sensors and outcome measures. Assessments include the 10-Meter Walk Test, Six Minute Walk Test, Timed Up and Go Test, Geriatric Depression Scale, Activities-Specific Balance Confidence Scale, and Stroke Impact Scale-16. Treatment will consist of 12 sessions of walking on the device for a goal of 30 minutes per session. Assessments will be repeated one-week, one-month, three-months, six-months, and 12-months after treatment. Feasibility and safety of the delivery method will be measured throughout the trial.

Who Is Running the Clinical Trial?

Moterum Technologies, Inc.

Lead Sponsor

Trials

3

Recruited

40+

Published Research Related to This Trial

The DELTA network study evaluated the safety of devices used in over 23,000 percutaneous coronary interventions from 2008 to 2012, revealing that the Perclose vascular closure device was associated with a significantly higher risk of minor vascular complications compared to alternative devices, with a relative risk of 4.14.

This study highlights the effectiveness of automated prospective safety surveillance in providing timely assessments of medical device safety, as it successfully identified safety alerts based on real-time data analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The data extraction and longitudinal trend analysis network study of distributed automated postmarket cardiovascular device safety surveillance. Kumar, A., Matheny, ME., Ho, KK., et al.[2020]

There is a significant gap in the safety evaluation of non-active implantable medical devices (NAIMDs) compared to medicines, particularly in the absence of a global program for collecting and analyzing adverse events and product quality issues.

Adopting methodologies from drug safety evaluations, such as utilizing real-world data sources like electronic health records and implementing unique device identifiers (UDI), could enhance the ongoing monitoring and assessment of NAIMD safety throughout their entire life cycle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines. Pane, J., Coloma, PM., Verhamme, KM., et al.[2018]

A review of 152 randomized controlled trials (RCTs) of antiepileptic drugs revealed that the reporting of adverse events (AEs) is inadequate, with an average of only 11.3 out of 23 CONSORT criteria being met, indicating a need for improvement in transparency.

Commercially funded trials reported AEs more thoroughly than non-commercial trials, and adult studies provided better reporting than those involving children, highlighting disparities that could affect the understanding of drug safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of adverse events in randomised controlled trials of antiepileptic drugs using the CONSORT criteria for reporting harms. Shukralla, AA., Tudur-Smith, C., Powell, GA., et al.[2022]

A significant portion of medical device adverse event reports submitted to the FDA's MAUDE database (approximately 47.9%) were classified as categories other than death, despite containing terms indicating that a patient had died.

The study found that about 23% of reports involving patient deaths were misclassified, suggesting that around 31,552 reports may have inaccurately categorized deaths, highlighting a critical need for improved accuracy in adverse event reporting to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death. Lalani, C., Kunwar, EM., Kinard, M., et al.[2022]

A total of 651 adverse events related to angiographic equipment were reported from July 2011 to July 2021, with the majority being near misses (67%) and serious safety events accounting for 11.2%.

While adverse events are generally rare, 34 incidents (5.2%) were linked to patient deaths, highlighting the need for improved equipment design and user training to enhance safety in endovascular procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Typology, Severity, and Outcomes of Adverse Events Related to Angiographic Equipment-A Ten-Year Analysis of the FDA MAUDE Database. Healy, GM., Ahrari, A., Alkhalifah, F., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10238959/

Gait Device Treatment Using Telehealth for Individuals ... This study explores the feasibility of using telehealth to deliver gait treatment using a wearable gait device, the iStride device, to stroke survivors during ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04434313

Study Details | NCT04434313 | Treatment of Hemiparetic ... Our primary study objective is to determine if telemedicine is a safe and feasible delivery method for treatment with the iStride ™ gait device. What is the ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37204830/

Gait Device Treatment Using Telehealth for Individuals ... Objective: This study explores the feasibility of using telehealth to deliver gait treatment using a wearable gait device, the iStride device, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04434313?tab=table

Treatment of Hemiparetic Gait Impairments Using ... An arm type in which a group of participants receives an intervention/treatment considered to be effective ... See Delay Results Type in the Results Data Element ...

5. withpower.com withpower.com/trial/phase-nervous-system-diseases-3-2020-6a093

Treatment of Hemiparetic Gait Impairments Using ... This trial tests the Moterum iStride Solution™, a device that helps stroke survivors improve their walking by making it more even and safe.

6. reedlab.eng.usf.edu reedlab.eng.usf.edu/iStrideDevice/

iStride™ Device - REED Lab at USF The iStride™ Device is an innovative, mobile, power-free device that enhances gait rehabilitation by replicating split-belt treadmill therapy ...