An interventional study of Real Stimulation and Sham Stimulation in Hand Function, Stroke and Upper Extremity, sponsored by TheraBracelet, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-07.
Sponsored by TheraBracelet, Inc. · 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 998th largest by enrollment of the 1,617 interventional ones that give a count, is one of 105 that started in 2018, is one of 1,121 with no phase, and was the 988th registered.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's enrollment of 26 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: 18 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. 105 started in 2018.
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:
This is the only study on the registry with TheraBracelet, Inc. as lead sponsor.
TheraBracelet, Inc. 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:
This project aims to test a new technology that may improve hand function impaired from a stroke, thereby improving independence and quality of life.
Post-stroke hand impairment is highly prevalent and severely restricts functional ability and independence. Yet, there is no assistive device to help hand function at home, every day, during activities of daily living. Existing devices such as hand-opening orthoses are expensive, uncomfortable, bulky, and meant for use during short therapy sessions as opposed to during daily living. Thus their impact is limited. Consequently, the development of efficacious and affordable assistive device is of importance. This project addresses this critical gap by providing an innovative patent-pending technology. The "TheraBracelet" is a wristband applying imperceptible vibration to skin. TheraBracelet is efficacious, as it has been shown to immediately improve chronic stroke survivors' touch sensation and hand dexterity in previous studies. TheraBracelet is affordable by using only a low-cost vibrator. TheraBracelet is also translational, because a vibrator strategically placed at the wrist does not interfere with dexterous finger motions, and it is low-risk by involving only imperceptible vibration on skin. These practicalities assure easy adoption in home environment for large impact on sensorimotor impairment. The essential next step, thus the objective of this Phase I project, is to determine the feasibility and safety of using this assistive device all day every day for a month during daily activity. This objective will be accomplished in a double-blinded, randomized, controlled, crossover design study. Feasibility (compliance of using the device everyday) and safety will be assessed for the real vibration condition compared to the sham vibration condition (wearing the device without vibration). The feasibility and safety level comparable to those of wearing a watch and of a comparable FDA-approved device will support viability of TheraBracelet with necessary regulatory approvals. This project is expected to lead to an assistive wristband that increases hand function during activities of daily living for a large number of stroke survivors with hand impairment.
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.
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.
Participants are instructed to wear the TheraBracelet device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. After 2-week washout, participants are again instructed to wear the device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. The device applies real stimulation in the first month. The device applies sham stimulation in the second month. The stimulation is imperceptible. Thus, participants do not perceive stimulation in either month.
Device: Real Stimulation · Device: Sham Stimulation
Participants are instructed to wear the TheraBracelet device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. After 2-week washout, participants are again instructed to wear the device on the affected wrist every day for at least 8 hours/day during their daily activity for 1 month. The device applies sham stimulation in the first month. The device applies real stimulation in the second month. The stimulation is imperceptible. Thus, participants do not perceive stimulation in either month.
Device: Real Stimulation · Device: Sham Stimulation
The device applies wrist vibration at a subthreshold (imperceptible) level.
The device applies no vibration.
Safety - Occurrence of Device-Related Adverse Events (AE)
Any worsening of hand sensation, dexterity, grip strength, upper limb pain, swelling, spasticity, skin irritation, or any other adverse events (assessed every week) that sustained until the end of the month or occurred at the end of the month.
Time frame: Two 1-month durations
Feasibility - User Compliance in Wearing the Device
Time frame: Two 1-month durations
| Milestone | Real Then Sham | Sham Then Real |
|---|---|---|
| Started | 13 | 13 |
| Completed | 13 | 12 |
| Not completed | 0 | 1 |
| Milestone | Real Then Sham | Sham Then Real |
|---|---|---|
| Started | 13 | 12 |
| Completed | 13 | 12 |
| Not completed | 0 | 0 |
Any worsening of hand sensation, dexterity, grip strength, upper limb pain, swelling, spasticity, skin irritation, or any other adverse events (assessed every week) that sustained until the end of the month or occurred at the end of the month.
| Participants | Real Then Sham | Sham Then Real |
|---|---|---|
| AE Month 1 | 2 | 4 |
| AE Month 2 | 0 | 1 |
| Participants | Real Then Sham | Sham Then Real |
|---|---|---|
| Compliance Month 1 | 13 | 12 |
| Compliance Month 2 | 13 | 12 |
Collected over Adverse event data were collected for 2.5 month study period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Real Then Sham - Month 1 (Real) | 0/13 (0%) | 1/13 (7.7%) | 8/13 (61.5%) |
| Sham Then Real - Month 1 (Sham) | 0/12 (0%) | 2/12 (16.7%) | 6/12 (50%) |
| Real Then Sham - Month 2 (Sham) | 0/13 (0%) | 0/13 (0%) | 6/13 (46.2%) |
| Sham Then Real - Month 2 (Real) | 0/12 (0%) | 0/12 (0%) | 7/12 (58.3%) |
| Event | Real Then Sham - Month 1 (Real) | Sham Then Real - Month 1 (Sham) | Real Then Sham - Month 2 (Sham) | Sham Then Real - Month 2 (Real) |
|---|---|---|---|---|
| Transient ischemic attack-like symptomsGeneral disorders | 0/13 | 2/12 | 0/13 | 0/12 |
| Skin surgerySkin and subcutaneous tissue disorders | 1/13 | 0/12 | 0/13 | 0/12 |
| Event | Real Then Sham - Month 1 (Real) | Sham Then Real - Month 1 (Sham) | Real Then Sham - Month 2 (Sham) | Sham Then Real - Month 2 (Real) |
|---|---|---|---|---|
| Temporary feeling of numbness or worsening in sensory scoresGeneral disorders | 3/13 | 3/12 | 2/13 | 5/12 |
| Temporary swellingGeneral disorders | 0/13 | 0/12 | 1/13 | 3/12 |
| Temporary skin irritationSkin and subcutaneous tissue disorders | 3/13 | 1/12 | 2/13 | 1/12 |
| Temporary increase in painGeneral disorders | 0/13 | 2/12 | 0/13 | 1/12 |
| OtherGeneral disorders | 2/13 | 0/12 | 2/13 | 1/12 |
| Temporary reduction in grip strengthMusculoskeletal and connective tissue disorders | 1/13 | 0/12 | 1/13 | 1/12 |
| Temporary increase in Modified Ashworth scale scoresGeneral disorders | 1/13 | 0/12 | 0/13 | 0/12 |
| Age, Continuous(years) | Real Then Sham | Sham Then Real | Total |
|---|---|---|---|
| Mean | 62 ± 11 | 58 ± 10 | 60 ± 11 |
| Sex: Female, Male(Participants) | Real Then Sham | Sham Then Real | Total |
|---|---|---|---|
| Female | 4 | 4 | 8 |
| Male | 9 | 9 | 18 |
| Ethnicity (NIH/OMB)(Participants) | Real Then Sham | Sham Then Real | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 12 | 12 | 24 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Real Then Sham | Sham Then Real | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 6 | 11 |
| White | 7 | 6 | 13 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(participants) | Real Then Sham | Sham Then Real | Total |
|---|---|---|---|
| United States | 13 | 13 | 26 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Upon request.
Time frame: The data will become available within 1 year from the study completion date for 6 years.
Access criteria: De-identified data only
Ran from Jan 2018 to primary completion in Oct 2018, 9 months.
Results were first posted in Mar 2019, 4 months after primary completion.
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 9 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 completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
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