A Multicenter, Randomized, Controlled Study to Evaluate the Efficacy and Safety of the SSMD in Neuromotor Rehabilitation
This is a multicenter, randomized, controlled clinical study evaluating the safety and effectiveness of the Spatial StimelMD (SSMD) device for upper-limb neuromotor rehabilitation in adults with impairment following stroke or traumatic brain injury (TBI). Participants will be randomized to receive either SSMD therapy plus standard rehabilitation care or standard functional electrical stimulation (FES) plus standard care. Subjects will complete approximately 25 supervised treatment sessions over 5-6 weeks, with assessments at baseline, mid-treatment, post-treatment (primary endpoint), and a 1-month follow-up. The primary effectiveness endpoint is improvement in upper-limb motor function measured by the Fugl-Meyer Upper Extremity (FMA-UE) assessment. Secondary outcomes include movement metrics, EMG signal strength, functional independence, usability measures, and adverse event monitoring. The study plans to enroll approximately 150 subjects to achieve 126 completers, across 2-6 clinical sites.
• Adults aged 18-80 years.
• Clinically confirmed diagnosis of stroke or TBI within the past 12 months.
• Presence of moderate to severe neuromotor impairment in at least one limb, as evidenced by medical evaluation and a score \<35 on the Fugl-Meyer Upper Extremity motor subscale (FMA-UE).
• Capacity and willingness to provide informed consent, indicating understanding of the study purpose, procedures, and potential risks and benefits.
• Subject is able to adhere to the study schedule and cognitively capable to perform the treatment.
• Stable medical condition without ongoing acute complications that could interfere with participation.