Radar des Essais Cliniques

This NIH Phase II SBIR study evaluates the usability and clinical potential of the RWH system through three integrated aims:

Aim 1: Usability Optimization of the RWH Device This aim focuses on optimizing the hardware components of the RWH device including harness fitting, footplate setup, session transitions, and safety mechanisms through human factor testing and structured feedback. A usability-focused prototype will be iteratively refined based on feedback from individuals with stroke or SCI. Each participant will complete device trials under supervision, and usability will be evaluated using the System Usability Scale (SUS). The goal is to achieve a SUS score of ≥74, indicating above-average usability.

Aim 2: Software Usability Optimization of the Touchscreen Interface and Online Dashboard This aim focuses on development and evaluation the RWH's integrated software platform, including the touchscreen interface and web-based dashboard used for session control, data monitoring, and connectivity. Participants will complete guided interaction tasks and structured interviews. Usability metrics will include navigation ease, interface clarity, connectivity stability, and safety alert functionality. Overall usability will be evaluated using the System Usability Scale (SUS). The goal is to achieve a SUS score of ≥74, indicating above-average usability. Both device and dashboard usability will be refined through iterative development based on user feedback.

Aim 3: Pilot Randomized Controlled Trial Evaluating Clinical Effectiveness This is a parallel-group randomized controlled trial evaluating the clinical feasibility, safety, and preliminary efficacy of the RWH device used in the home setting by individuals with post-stroke lower extremity impairments. Participants will be recruited and enrolled through the Kessler Institute for Rehabilitation. After informed consent and eligibility screening including device trialing and a home environment assessment. 20 individuals will be randomized (1:1) into a treatment group or a usual care control group.

At baseline, all participants will receive a Fitbit tracker to record daily step counts, beginning one week before intervention. Clinical assessments at Kessler Institute will include the 6-Minute Walk Test (6MWT), 10-Meter Walk Test (10MWT), and SF-36 Quality of Life questionnaire.

Treatment Group: Participants will have the RWH system installed in their homes and will receive training or refresher instruction as needed. They will be instructed to use the RWH at least 30 minutes per session, four times per week. These sessions may be completed in multiple bouts of ≥10 minutes. Device use is self-paced using a built-in Rate of Perceived Exertion (RPE) monitor. Parameters are individualized and configured by the study team based on baseline performance.

Control Group: Participants will continue with usual care physical therapy based on their therapist's recommendations and personal accessibility. This may include home health, outpatient therapy, or no therapy if services are unavailable.

Outcomes will be measured monthly at Kessler Institute by study staff. The primary endpoint is walking endurance (6MWT). Secondary outcomes include walking speed (10MWT), quality of life (SF-36), usability, participant satisfaction, and safety. Weekly check-in calls will monitor participant progress, troubleshoot technical issues, and assess adverse events. The RWH system's integrated dashboard will track adherence and RPE scores.

This study aims to demonstrate that home-based, robotic-assisted gait training using the RWH system is not only safe and feasible, but may also lead to greater improvements in mobility and independence compared to usual care. Upon completion of the clinical trial the technology will seek registration with the FDA. This is a 510(k) exempt device which does not require FDA regulation.