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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Spatial StimelMD (SSMD)
DeviceSpatial StimelMD (SSMD) is a device-based neuromotor rehabilitation intervention used for upper-limb therapy. Participants receive SSMD therapy in supervised sessions as part of a structured rehabilitation program over approximately 5-6 weeks (about 25 sessions).
Functional Electrical Stimulation (FES)
DeviceFunctional electrical stimulation (FES) is a standard device-based intervention used in rehabilitation to stimulate muscle activation for upper-limb therapy. Participants receive FES in supervised sessions as part of standard rehabilitation care over approximately 5-6 weeks (about 25 sessions).
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: SSMD Therapy + Standard CareExperimental treatment 1 intervention
Group B: Standard FES + Standard CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
Change from baseline to end of treatment in the Fugl-Meyer Assessment Upper Extremity (FMA-UE) motor function score (range 0-66), with higher scores indicating better motor function (better outcome).
Time frame
Baseline to end of treatment (post-treatment; approximately 5-6 weeks)Secondary outcomes
1
Movement Quality (SSMD Assessment Mode)
Change in upper-limb movement quality measured using SSMD assessment mode metrics.
Time frame
Baseline to end of treatment (approximately 5-6 weeks)2
EMG Signal Strength (Threshold)
Change in EMG signal strength (threshold) measured during study assessments.
Time frame
Baseline to end of treatment (approximately 5-6 weeks)3
Functional Independence Measure (FIM)
Change from baseline to end of treatment in the Functional Independence Measure (FIM) total score (range 18-126), with higher scores indicating greater functional independence (better outcome).
Time frame
Baseline to end of treatment (approximately 5-6 weeks)Other outcomes
1
Modified Ashworth Scale (MAS)
Change from baseline in spasticity measured by the Modified Ashworth Scale (range 0-4; higher scores indicate worse spasticity). Time Frame: Baseline to end of treatment (5-6 weeks).
Time frame
Baseline to end of treatment (approximately 5-6 weeks)Sponsors and contacts
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Source ClinicalTrials.gov