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RECRUITING
NCT07404761
NA

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

Sponsor: Motion Informatics LTD

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-12-22

Completion Date

2026-12-30

Last Updated

2026-02-11

Healthy Volunteers

No

Interventions

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).

Locations (1)

Bnai Zion Medical Center

Haifa, Israel