Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SSMD + Conventional Therapy | Experimental | Participants receive SSMD sessions in addition to conventional therapy for 18 sessions (30 minutes each), delivered 6 sessions per week over 3 weeks. |
|
| FES + Conventional Therapy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSMD | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to post-treatment (end of treatment, 3 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to post-treatment (end of treatment, Week 3) |
| Change in Functional Independence Measure (FIM) score |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to post-treatment (end of treatment, Week 3) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Polsko-Amerykańskie Kliniki Serca SA, Uzdrowisko Ustroń | Ustroń | 43-450 | Poland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will be randomized (1:1) into two parallel groups to receive either SSMD plus conventional therapy or FES plus conventional therapy
Not provided
Not provided
This is an open-label study. No masking/blinding is implemented due to the nature of the device interventions and treatment delivery
Not provided
| Functional Electrical Stimulation (FES) | Device | 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 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). |
| 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. | 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). |
| 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). | 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. | 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). | Post-treatment (end of treatment, Week 3) |
| Adverse events (AEs) | Frequency and severity of all adverse events (AEs), related or unrelated to study treatment. | 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). | Post-treatment (end of treatment, Week 3) |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D013119 | Spinal Cord Injuries |
| D009443 | Neuritis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013118 | Spinal Cord Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
Not provided
Not provided