A Phase 1 interventional study of HandSOME in Stroke, sponsored by The Catholic University of America. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2020-08-28.
Sponsored by The Catholic University of America · Phase 1, 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 1,240th largest by enrollment of the 1,617 interventional ones, is one of 96 that started in 2017, is one of 126 in phase 1, and was the 978th registered.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's enrollment of 15 is below 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 and older · 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. 96 started in 2017.
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:
The Catholic University of America is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
The Catholic University of America has 4 studies 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:
This research will evaluate the potential for a novel hand orthosis (HandSOME) to help stroke victims regain functional use of their hand and regain independent living. Participants will use the HandSOME at home regularly for 8 weeks. Clinical evaluations will measure changes from the intervention after the 8 weeks and also at a 3 month followup.
After stroke, individuals often have great difficulty with using the affected hand in functional tasks. The hand frequently suffers from finger flexor hypertonia as well as finger extensor weakness. This leads to increased difficulty in grasp and release of objects. HandSOME is a light weight wearable hand orthosis that increases range of motion and decreases effort during grasping tasks. The goal of this study is to evaluate the HandSOME device's effectiveness in the rehabilitation of stroke patients through an 8 week intervention. Eligible subjects will use the device daily at home for 8 weeks with one visit per week to the clinic to evaluate progress and troubleshoot problems with the device. The hypotheses are that the gains from the 8 weeks of training will be statistically significant and clinically important (defined as gains of greater than 10% of full scale) in the domains of impairment, function and amount of arm use.
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.
The intervention is given to this group.
Device: HandSOME
Participants use the HandSOME orthosis daily for 8 weeks.
Change in Fugl-Meyer Test of Arm Function
clinical test of arm motor ability and impairment
Time frame: Change from baseline Fugl-Meyer score at 2 months
Change in Action Research Arm Test
clinical test of the functional limitations of the upper extremities
Time frame: Change from baseline Action Research Arm Test score at 2 months
Change in Motor Activity Log
assess the amount and quality of limb use at home
Time frame: Change from baseline Motor Activity Log score at 2 months
Change in Fugl-Meyer Test of Arm Function at followup
clinical test of arm motor ability and impairment
Time frame: Change from baseline Fugl-Meyer score at 5 months
Change in Action Research Arm Test at followup
clinical test of the functional limitations of the upper extremities
Time frame: Change from baseline Action Research Arm Test score at 5 months
Change in Motor Activity Log at followup
assess the amount and quality of limb use at home
Time frame: Change from baseline Motor Activity Log score at 5 months
Plan to share: No
Ran from Apr 2017 to primary completion in Oct 2019, 29 months.
Of 71 non-industry phase 1 interventional studies under Stroke, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 29 months is close to that.
Counting every sponsor, half of 97 studies reached it within 20 months; a quarter within 7 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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The Catholic University of America