Treatment of Hemiparetic Gait Impairments Using Telehealth With the Moterum iStride Solution™

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

6 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests the Moterum iStride Solution™, a device that helps stroke survivors improve their walking by making it more even and safe. It is designed for people who have trouble walking due to a stroke. The device mimics a special treadmill and uses sensors to track progress, with therapists providing remote support through video calls.

Will I have to stop taking my current medications?

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

Is the iStride™ device generally safe for humans?

There is no specific safety data available for the iStride™ device in the provided research articles. However, the safety evaluation of non-active implantable medical devices (NAIMDs) like the iStride™ device is generally less comprehensive than that for medicines, and there is a need for better monitoring of real-world usage to ensure safety. ^{1 2 3 4 5}

Research Team

Stephen T. Shultz, PT, DPT, OCS

Principal Investigator

Wingate University

Eligibility Criteria

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

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

Treatment Details

Interventions

• iStride™ device

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Reporting of adverse events in randomised controlled trials of antiepileptic drugs using the CONSORT criteria for reporting harms. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The data extraction and longitudinal trend analysis network study of distributed automated postmarket cardiovascular device safety surveillance. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death. [2022]

5. United States 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. [2023]