Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMotion Informatics LTD
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 (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.
Eligibility criteria
Qualifiers
Adults aged 18-80 years.
Clinically confirmed diagnosis of stroke or TBI within the past 12 months.
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 subscale (FMA-UE).
Capacity and willingness to provide informed consent, indicating understanding of the study purpose, procedures, and potential risks and benefits.
Disqualifiers
Presence of contraindications to electrical stimulation (ES), including implanted electronic medical devices (e.g., pacemakers, insulin pumps) or conditions that may be exacerbated by electrical stimulation (e.g., uncontrolled epilepsy).
Individuals with medical conditions, which are prone to seizures or motion sensitivity, at the investigator's discretion.
Individuals with light sensitivity, as the AR component may involve visual stimuli that could cause discomfort or adverse reactions in these patients.
Individuals with acute physical conditions or injuries that could interfere with the proper placement of the electrodes or safe use of the device.
Trial design
Treatments tested in this trial
- Spatial StimelMD (SSMD)
- Functional Electrical Stimulation (FES)
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov