Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments
Recruiting
N/A
Interventional Study
Stroke
Upper-limb Motor Impairment
Hemiparesis
Spinal Cord Injury
Traumatic Brain Injury
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- Motion Informatics LTD · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Adults aged 18-80 years.
2. Clinically confirmed diagnosis of stroke or TBI within the past 12 months.
3. 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 sub…
Contacts