Treatment of Hemiparetic Gait Impairments Using Telehealth With the Moterum iStride Solution™
Condition: Telemedicine; Gait, Hemiplegic; Gait Disorders, Neurologic; Stroke; Orthotic Devices; Gait Analysis
MeSH terms: Nervous System Diseases; Gait Disorders, Neurologic
Study type: Interventional

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.
    

Intervention name(s): Delivery of iStride™ device gait treatment using telemedicine
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: iStride; Telehealth; Telerehabilitation; Gait Speed