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

NCT04434313 | Completed FDA Device

• 1 other identifier: MOT-TELE-2020-04-00
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this research is to investigate the feasibility of delivering gait treatment using the Moterum iStride Solution™ to individuals with hemiparetic gait impairments using a telemedicine modality, the Moterum Digital Platform.

Conditions

Telemedicine; Gait, Hemiplegic; Gait Disorders, Neurologic; Stroke; Orthotic Devices; Gait Analysis

Keywords

iStride; Telehealth; Telerehabilitation; Gait Speed

Outcome Measures

Primary Outcomes (2)

• Feasibility of safely implementing the treatment protocol

  The described delivery method includes using remote physical therapist treatment oversight and physical supervision of treatment activities by trained caregivers. Due to the inclusion criteria, patients already have some risk of falls and need for assistance while walking. The caregivers will record assistance levels provided during treatment. Any adverse events will be immediately reported and reviewed. The remote physical therapists will regularly review assistance levels to ensure the participant is requiring an appropriate level of assistance. The feasibility of safely delivering treatment will be assessed by two measures: (a) the daily safety rate, defined as the percentage of days an adverse event occurred out of the total number of treatment days, and (2) assistance required and adverse events experienced for each participant, compared to the group, and compared to our prior research.

  Determined at the end of the 12-session treatment period (approximately 4 weeks after beginning the treatment).

• Achievability of telemedicine delivery protocol

  The achievability of this treatment delivery method will be assessed by measuring participant compliance to the protocol tasks. These tasks include scheduled treatment sessions, functional and psychosocial outcome measures, and sensor-based activities. Achievability will be defined as the percentage of completed protocol activities out of the total scheduled activities.

  Determined within one week after the final follow-up assessment (12-month follow-up) is completed. The 12-month follow-up assessment will occur 12-months after completion of the 4-week treatment period.

Secondary Outcomes (2)

• Feasibility of screening criteria

  Determined at the end of the 12-session treatment period (approximately 4 weeks after beginning the treatment).

• Stakeholder Acceptability

  Determined within one week after the final follow-up assessment (12-month follow-up) is completed. The 12-month follow-up assessment will occur 12-months after completion of the 4-week treatment period.

Study Arms (1)

Delivery of iStride™ device gait treatment using telemedicine

EXPERIMENTAL

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.

Device: Delivery of iStride™ device gait treatment using telemedicine

Interventions

Delivery of iStride™ device gait treatment using telemedicine DEVICE

The gait device used in this study mimics the actions of the split-belt treadmill but can be used during overground 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. This research aims to adapt the delivery mechanism of treatment with the iStride™ device to include telemedicine. The telemedicine platform of reference in this study, the Moterum Digital Platform, is an integrated therapeutic platform which offers an activity library, real-time video conferencing, and outcomes tracking. Our primary study objective is to determine if telemedicine is a safe and feasible delivery method for treatment with the iStride ™ gait device.

Delivery of iStride™ device gait treatment using telemedicine

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
• 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
• If hemiparesis is due to a stroke, the stroke occurred at least 3 months prior to enrollment
• Gait asymmetry
• Able to walk independently with or without a cane or hemiwalker, (Modified Rankin Score 3 or less)
• No evidence of severe cognitive impairment that would interfere with understanding the instructions
• At least 25 feet of walking space (does not need to be a straight line)
• Weight does not exceed 275lbs

You may not qualify if:

• Uncontrolled seizures
• Metal implants (stents, clips, pacemaker)
• Pregnancy
• Chronic Obstructive Pulmonary Disease
• Uncontrolled blood pressure
• Myocardial infarction within the last 180 days
• Cannot rely on a rolling walker for ambulation
• Severe ataxia interfering with safety on the device
• Previously diagnosed vestibular ear issues interfering with safety on the device

Sponsors & Collaborators

• Moterum Technologies, Inc.: lead

Study Sites (1)

Moterum Technologies, Inc. (study location: homes throughout United States)

Salt Lake City, Utah, 84115, United States

Location

Related Publications (5)

• Reed KB, Handzic, Ismet, Inventor; University of South Florida, assignee. Gait Altering Shoes. US patent 9,295,302. March 29, 2016, 2016.

  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

• 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

• 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, Shultz ST, Tsai NT, Huizenga D, Reed KB, Bamberg SJM. Gait Device Treatment Using Telehealth for Individuals With Stroke During the COVID-19 Pandemic: Nonrandomized Pilot Feasibility Study. JMIR Form Res. 2023 May 19;7:e43008. doi: 10.2196/43008.

  PMID: 37204830 DERIVED

MeSH Terms

Conditions

Gait Disorders, Neurologic; Stroke

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Stephen T. Shultz, PT, DPT, OCS

  Wingate University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 16, 2020
• Study Start: April 20, 2020
• Primary Completion: December 19, 2020
• Study Completion: December 21, 2020
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)