NCT07404761

Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments

A Multicenter, Randomized, Controlled Study to Evaluate the Efficacy and Safety of the SSMD in Neuromotor Rehabilitation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Motion Informatics LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

CP-SSMD-01 is a multicenter, randomized, controlled clinical study designed to evaluate 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). The study compares SSMD therapy plus standard rehabilitation care to standard functional electrical stimulation (FES) plus standard care. Participants will complete approximately 25 supervised treatment sessions over a 5-6 week period. Subjects will undergo evaluations at baseline, mid-treatment, post-treatment (the primary endpoint), and a follow-up visit approximately one month after completing therapy. The primary outcome measure is improvement in upper-limb motor function assessed using the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE). Secondary outcomes include additional measures of motor performance and movement quality, EMG-based muscle activation metrics, functional independence outcomes, usability assessments, and safety monitoring through adverse event reporting. The study aims to enroll approximately 150 participants, with an expected 126 completing the full protocol, across 2-6 clinical sites. This trial is intended to generate clinical evidence on whether SSMD therapy can support meaningful upper-limb motor recovery compared with a standard stimulation-based rehabilitation approach in individuals affected by stroke or TBI.

Conditions

• Stroke
• Upper-limb Motor Impairment
• Hemiparesis
• Spinal Cord Injury
• Traumatic Brain Injury

Interventions

Type	Name	Description
DEVICE	Spatial StimelMD (SSMD)	Spatial StimelMD (SSMD) is a device-based neuromotor rehabilitation intervention used for upper-limb therapy. Participants receive SSMD therapy in supervised sessions as part of a structured rehabilitation program over approximately 5-6 weeks (about 25 sessions).
DEVICE	Functional Electrical Stimulation (FES)	Functional electrical stimulation (FES) is a standard device-based intervention used in rehabilitation to stimulate muscle activation for upper-limb therapy. Participants receive FES in supervised sessions as part of standard rehabilitation care over approximately 5-6 weeks (about 25 sessions).

Timeline

• Start date: 2025-12-22
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2026-02-11
• Last updated: 2026-02-11

Locations

1 site across 1 country: Israel