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.