Actively Recruiting
Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments
Led by Motion Informatics LTD · Updated on 2026-02-11
150
Participants Needed
1
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Clinically confirmed diagnosis of stroke or traumatic brain injury within the past 12 months
- Moderate to severe neuromotor impairment in at least one limb, with a Fugl-Meyer Upper Extremity motor score less than 35
- Ability and willingness to provide informed consent
- Ability to follow the study schedule and perform the treatment
- Stable medical condition without acute complications that could affect participation
You will not qualify if you...
- Contraindications to electrical stimulation such as implanted electronic medical devices like pacemakers or insulin pumps
- Medical conditions prone to seizures or motion sensitivity
- Light sensitivity that could be triggered by the augmented reality component
- Acute physical injuries or conditions that prevent safe use or proper electrode placement
- Presence of spinal shock or unresolved acute spinal cord dysfunction
- Participation in other clinical trials that may affect study results
- Severe cognitive impairment preventing informed consent or adherence
- Women who are pregnant, nursing, or planning pregnancy during the trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Bnai Zion Medical Center
Haifa, Israel, 3339419
Actively Recruiting
Research Team
V
Victoria Lashinker
CONTACT
J
Julia Sterlin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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