An interventional study of Wearable sensors and biofeedback in Stroke and Hemiparesis, sponsored by BioSensics. Status unknown at 1 site in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-03-02.
Sponsored by BioSensics · Not applicable, Interventional, and Treatment
Among 1,991 studies in Stroke with a site in United States — 394 open to participants now, 490 under way, 17 of them phase 3. Stroke · United States.
Among the 1,991 studies in Stroke with a site in United States, this one is the 584th largest by planned enrollment of the 1,617 interventional ones that give a count, is one of 117 that started in 2019, is one of 1,121 with no phase, and was the 1,025th registered.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 60 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →394 of the 1,991 studies in Stroke with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 1,415 Stroke studies recruiting now, 697 (49%) set no upper age limit and 280 (20%) stop at 75 or younger; 77 take children under 18; 196 take healthy volunteers.
This study: 21 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →1,991 studies; the count open now beside each. This study's row is marked.
First in 1980; this study’s year is marked. 117 started in 2019.
Median enrollment 40 across the 1,617 interventional studies, 153 across the 363 observational. Of the 1,327 that completed or were terminated, 561 (42%) have results posted.
295 of 1,991 have an industry lead sponsor. The 10 most frequent:
BioSensics is the lead sponsor of 12 studies on the registry; 8 are open to participants now.
BioSensics has 1 study filed under Stroke — fewer than ten, so there is no comparison to draw.
166 of the studies in Stroke with a site in United States that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05065216Phase 3DiaMedica Therapeutics IncTreatment of Acute Ischemic Stroke (ReMEDy2 Trial) | 2026-12 |
| NCT03223220Phase 3Lower Merion Neurology Research FoundationQuelling of Excitotoxicity in Acute Stroke With Ketamine | 2026-12-31 |
| NCT05047172Phase 3University of FloridaComparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis | 2027-01-31 |
| NCT05691244Phase 3Pharmazz, Inc.Assess the Safety and Efficacy of Sovateltide in Patients With Acute Cerebral Ischemic Stroke | 2027-09 |
| NCT05997914University of Massachusetts, WorcesterStorytelling for Reducing Gap in Anticoagulation Use in African Americans With Atrial Fibrillation | 2026-11 |
Among the 1,991 studies in Stroke with a site in United States, from their registry updates:
Stroke and other causes of central nervous system damage can result in debilitating loss of motor control that is often more pronounced in one limb than the other. Using or attempting to use the affected limb during activities of daily living, despite considerable difficulty, stimulates neuroplasticity and motor function recovery. The investigators are conducting a clinical study to test the efficacy of wrist-worn sensors that encourage affected limb use during activities of daily living.
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.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the Control Arm will wear sensors to monitor their upper limb movement but will not receive feedback from these sensors to encourage usage of the impaired limb during activities of daily living.
Participants in the Experimental Arm will wear sensors to monitor their upper limb movement and will receive feedback from these sensors to encourage usage of the impaired limb during activities of daily living.
Device: Wearable sensors and biofeedback
Participants in the Experimental Arm will wear sensors to monitor their upper limb movement and will receive feedback from these sensors to encourage usage of the impaired limb during activities of daily living.
Change in Fugl-Meyer during intervention
Change in Fugl-Meyer Upper Extremity Assessment Scale score from baseline (measure of upper extremity impairment, score range from 0 to 66 points, higher values are considered a better outcome).
Time frame: 12 weeks
Change in Motor Activity Log Quality Score during intervention
Change in Motor Activity Log Quality Score from baseline (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)
Time frame: 12 weeks
Change in Motor Activity Log Quantity Score during intervention
Change in Motor Activity Log Quantity Score from baseline (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)
Time frame: 12 weeks
Change in Fugl-Meyer during washout
Change in Fugl-Meyer Upper Extremity Assessment Scale score from end of intervention to follow-up (measure of upper extremity impairment, score range from 0 to 66 points, higher values are considered a better outcome).
Time frame: 12 weeks (end of intervention), 20 weeks (follow-up)
Change in Motor Activity Log Quality Score during washout
Change in Motor Activity Log Quality Score from end of intervention to follow-up (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)
Time frame: 12 weeks (end of intervention), 20 weeks (follow-up)
Change in Motor Activity Log Quantity Score during washout
Change in Motor Activity Log Quantity Score from end of intervention to follow-up (measure of hemiparetic upper extremity use in daily life, score range from 0 to 5 points, higher values are considered a better outcome)
Time frame: 12 weeks (end of intervention), 20 weeks (follow-up)
Change in Wolf Motor Function Test time-subscale during intervention
Change in Wolf Motor Function Test time-subscale score from baseline (measure of upper extremity function, score range from 0 to 120 seconds, lower values are considered a better outcome)
Time frame: 12 weeks
Change in Wolf Motor Function Test quality-subscale during intervention
Change in Wolf Motor Function Test quality-subscale score from baseline (measure of upper extremity function, score range from 0 to 5 points, higher values are considered a better outcome)
Time frame: 12 weeks
Change in Wolf Motor Function Test time-subscale during washout
Change in Wolf Motor Function Test time-subscale score from end of intervention to follow-up (measure of upper extremity function, score range from 0 to 120 seconds, lower values are considered a better outcome)
Time frame: 12 weeks (end of intervention), 20 weeks (follow-up)
Change in Wolf Motor Function Test quality-subscale during washout
Change in Wolf Motor Function Test quality-subscale score from end of intervention to follow-up (measure of upper extremity function, score range from 0 to 5 points, higher values are considered a better outcome)
Time frame: 12 weeks (end of intervention), 20 weeks (follow-up)
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2019 (actual). Primary completion is estimated for Aug 2021, 29 months after the start.
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 29 months is above 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 status unknown, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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