Clinical trial NCT04434313: Treatment of Hemiparetic Gait Impairments Using Telehealth With the Moterum iStride Solution™
Official title: Treatment of Hemiparetic Gait Impairments Using Telehealth With the Moterum iStride Solution™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
Gait, Hemiplegic
Gait Disorders, Neurologic
Stroke
Orthotic Devices
Gait Analysis
Keywords: iStride
Telehealth
Telerehabilitation
Gait Speed
Lead sponsor: Moterum Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-16
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Hemiparesis, a common disabling consequence of stroke and other neurologic conditions, can lead to abnormal gait function often characterized by asymmetric patterns and decreased gait speed. A large percentage of stroke survivors, up to 70%, experience gait dysfunction, which can lead to reduced activity levels, limited community participation, and contribute to an increased risk of falls. Effective interventions to treat gait dysfunction are essential to reduce disability for these individuals.

The iStride™ gait device, initially designed to mimic the symmetry-improving mechanism of a split-belt treadmill, was developed to treat asymmetric gait impairments in stroke survivors. Unlike many currently available gait treatment devices, the iStride™ device is portable, therefore allowing gait treatment to occur overground and from the home environment. Training in natural environments is believed to enhance the transfer of learning as well as enable long-term training. Previously published studies with the iStride™ device demonstrate its ability to beneficially improve functional gait parameters, gait speed, and reduce fall risk in both clinical and home settings.

To monitor improvement in gait function, the device is paired with patented iStride sensors™. The combined system, the Moterum iStride Solution™, is currently being used by stroke survivors in the home environment. In the current delivery model, users are provided instruction and training from physical therapists in clinical settings before using the device in their home environment under the supervision of a Moterum staff member. User feedback has led to the exploration of novel methods to deliver device treatment remotely. \[Additionally, the need for remote treatment has increased in urgency with the onset of the coronavirus pandemic and social distancing guidelines.\]

In this study, treatment with the iStride™ will be adapted to remote delivery using a telemedicine platform, the Moterum Digital Platform. A screening process will be implemented to guide participant selection and identify individuals likely to be successful with remote treatment delivery using the telemedicine modality. This process consists of an initial eligibility criteria review followed by a physical therapist video review of participant walking patterns.

Once enrolled in the clinical trial, participants will receive study-related equipment including the iStride™ device, Moterum iStride Hub and Sensors™, and a pre-measured strap for gait testing. They will be instructed in the download of the Moterum Digital Platform which will serve as the telemedicine modality for subsequent communication. Participants and their caregivers will be provided with instructional videos as well as therapist training on study procedures using video calls through the telemedicine platform. Instruction will include telemedicine portal navigation, iStride™ fitting (donning/doffing), mobility and walking guidelines with iStride™ device, assessment performance, environmental considerations, safety precautions, and caregiver guidelines and responsibilities.

Changes to gait patterns will be assessed using specialized gait sensors and functional outcome measures before, during, and after the treatment. Caregivers will be trained in the performance of these outcome measures which can be overseen by physical therapists through video conferencing.

Feasibility, compliance, and safety of the delivery method will be investigated throughout the trial using prompted questions within the Moterum Digital Platform and integrated forms to be completed by the participant and/or caregiver. After treatment is completed, participants and their caregivers will be surveyed to obtain feedback regarding usability, satisfaction, and sentiments regarding the remote delivery model.

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
* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility of safely implementing the treatment protocol
timeFrame: Determined at the end of the 12-session treatment period (approximately 4 weeks after beginning the treatment).
measure: Achievability of telemedicine delivery protocol
timeFrame: 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:
measure: Feasibility of screening criteria
timeFrame: Determined at the end of the 12-session treatment period (approximately 4 weeks after beginning the treatment).
measure: Stakeholder Acceptability
timeFrame: 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.
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Moterum Technologies, Inc. (study location: homes throughout United States)
state: Utah
Study officials:
affiliation: Wingate University
name: Stephen T. Shultz, PT, DPT, OCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reed KB, Handzic, Ismet, Inventor; University of South Florida, assignee. Gait Altering Shoes. US patent 9,295,302. March 29, 2016, 2016.
citation: 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.
citation: 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.
citation: 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.