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

Sponsor
Motion Informatics LTD
Study ID
NCT07404761
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Spatial StimelMD (SSMD) — DEVICE
    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).
  • Functional Electrical Stimulation (FES) — DEVICE
    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).

Study Details

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.

Key Dates

First listed
Feb 11, 2026
Start date
Dec 22, 2025
Status verified
Feb 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SSMD Therapy + Standard Care
    Participants receive Spatial StimelMD (SSMD) therapy in addition to standard rehabilitation care. Treatment includes approximately 25 supervised sessions delivered over 5-6 weeks.
  • Active Comparator: Standard FES + Standard Care
    Participants receive standard functional electrical stimulation (FES) in addition to standard rehabilitation care. Treatment includes approximately 25 supervised sessions delivered over 5-6 weeks.

Primary Outcome Measure

Fugl-Meyer Assessment - Upper Extremity (FMA-UE) [ Time Frame: Baseline to end of treatment (post-treatment; approximately 5-6 weeks) ]

Central Contacts

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