An interventional study of SSMD and Functional Electrical Stimulation (FES) in Stroke, TBI and Spinal Cord Injury, sponsored by Motion Informatics LTD. Not yet recruiting at 1 site in Poland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-11.
Sponsored by Motion Informatics LTD · Not applicable, Interventional, and Treatment
This study will evaluate the safety and performance of the Spatial StimeMD (SSMD) medical device in people with multiple sclerosis (MS). The SSMD device is intended to support patients through a non-invasive stimulation program. The study will assess changes in MS-related symptoms and physical function using clinical assessments and patient-reported outcomes.
This is a clinical investigation of the Spatial StimeMD (SSMD) medical device in participants diagnosed with multiple sclerosis (MS). The purpose of the study is to evaluate the safety and performance of the device in a controlled clinical setting. Participants will be followed according to the study schedule and will undergo assessments of MS symptoms, physical function, and other relevant clinical outcomes. Safety will be assessed through monitoring of adverse events and other safety parameters throughout the study. Study data will be collected and reviewed according to the protocol, including verification against source documentation as required.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 120 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Motion Informatics LTD is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive SSMD sessions in addition to conventional therapy for 18 sessions (30 minutes each), delivered 6 sessions per week over 3 weeks.
Device: SSMD
Participants receive functional electrical stimulation (FES) sessions in addition to conventional therapy for 18 sessions (30 minutes each), delivered 6 sessions per week over 3 weeks.
Device: Functional Electrical Stimulation (FES)
SSMD device-based therapy delivered in addition to conventional therapy. Participants receive 18 sessions, 30 minutes each, administered 6 sessions per week over 3 weeks.
Functional electrical stimulation (FES) delivered in addition to conventional therapy. Participants receive 18 sessions, 30 minutes each, administered 6 sessions per week over 3 weeks.
Change in Fugl-Meyer Upper Extremity (FMA-UE) motor score
Change from baseline in Fugl-Meyer Assessment Upper Extremity (Motor Function Subscale) The Fugl-Meyer Assessment Upper Extremity motor score is a clinician-rated measure of upper limb motor impairment following neurological injury. Scores range from 0 to 66, with higher scores representing less impairment and better motor function. Time Frame: Baseline to post-treatment (3 weeks).
Time frame: Baseline to post-treatment (end of treatment, 3 weeks)
change in Movement range and movement quality (SSMD assessment mode)
Change from baseline to post-treatment in movement range and movement quality as assessed using the SSMD system assessment mode.
Time frame: Baseline to post-treatment (end of treatment, Week 3)
Change in Functional Independence Measure (FIM) score
Change from baseline to post-treatment in activities of daily living as measured by the Functional Independence Measure (FIM) total score (range 18-126, higher scores indicate greater independence and better functional outcome). Time Frame: Baseline to end of treatment (Week 3).
Time frame: Baseline to post-treatment (end of treatment, Week 3)
Change in EMG signal strength (threshold)
Change from baseline to post-treatment in electromyography (EMG) signal strength (threshold) during device-assisted assessment.
Time frame: Baseline to post-treatment (end of treatment, Week 3)
Change in Modified Ashworth Scale (MAS)
Change from baseline to post-treatment in spasticity as measured by the Modified Ashworth Scale (range 0-4; higher scores indicate greater spasticity and worse outcome). Time Frame: Baseline to end of treatment (Week 3).
Time frame: Baseline to post-treatment (end of treatment, Week 3)
Change in Stroke Impact Scale (SIS) score
Change from baseline to post-treatment in Stroke Impact Scale (SIS) score (range 0-100; higher scores indicate better function and less stroke impact). Time Frame: Baseline to end of treatment (Week 3).
Time frame: Baseline to post-treatment (end of treatment, Week 3)
Change in NIH Stroke Scale (NIHSS) score
Change from baseline to post-treatment in National Institutes of Health Stroke Scale (NIHSS) score (range 0-42; higher scores indicate more severe neurologic deficit and worse outcome). Time Frame: Baseline to end of treatment (Week 3).
Time frame: Baseline to post-treatment (end of treatment, Week 3)
Change in Active Range of Motion (AROM) measured by goniometer
Change from baseline to post-treatment in active range of motion (AROM) (0-70 degrees), measured by goniometer.
Time frame: Baseline to post-treatment (end of treatment, Week 3)
System Usability Scale (SUS) score
System usability assessed by the System Usability Scale (SUS) (range 0-100; higher scores indicate better usability). Time Frame: Post-treatment (Week 3).
Time frame: Post-treatment (end of treatment, Week 3)
Adverse events (AEs)
Frequency and severity of all adverse events (AEs), related or unrelated to study treatment.
Time frame: Baseline through end of follow-up (up to 6 weeks)
Observer usability questionnaire score
Observer-reported usability will be assessed using a custom Observer Usability Questionnaire evaluating effectiveness and efficiency of device use (e.g., task accuracy, ease of navigation, and assistance required). Questionnaire items are rated on a 5-point scale (1 = poorest performance/usability, 5 = best performance/usability). An overall usability score will be calculated as the mean of the rated items, with higher scores indicating better usability and task performance. Time Frame: Post-treatment (end of treatment, Week 3).
Time frame: Post-treatment (end of treatment, Week 3)
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2026, 0 months later.
Of 144 industry-sponsored interventional studies with no phase under Stroke, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 0 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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