Key results at a glance
vs no device
Participants with a lower (better) tremor severity rating from a blinded neurologist when wearing the device than when wearing nothing. Blinded study, 9 adults with Essential Tremor.
vs weighted placebo
Compared with a placebo device of identical look and weight, worn by the same participants. This controls for the effect of added weight and expectation.
lower severity vs no device
Average fall in clinician-rated tremor severity across three tasks. Against the weighted placebo, the average fall was 29%.
after one week at home
Participants in a separate one-week follow-up (12 people) who reported significant improvement, with no adverse events. Self-reported, with no comparison group.
The same spiral, minutes apart
The Archimedes spiral is one of the three tasks scored blind in the study. These proof-of-concept tracings come from one person with moderate to severe Essential Tremor.
Without the device
With the Steadi-3
How the study was run
Nine adults with Essential Tremor did three tasks (drinking from a cup, finger to nose, and drawing an Archimedes spiral) under three conditions, in random order:
- No device.
- A weighted placebo device of identical appearance, with no active mechanism.
- The Steadi-3.
Blinding
Recordings were masked, then scored blind by a neurologist on a modified Fahn-Tolosa-Marín scale. The scorer did not know which condition they were watching.
Funding
The study was designed, run and funded by Steadiwear Inc. (internal report, February 2025, available on request). Read the results with that in mind.
What the neurologists measured
| Score | Severity |
|---|---|
| 0 | No tremor |
| 1 | Mild tremor (barely visible) |
| 2 | Moderate tremor (visible, may interfere with task) |
| 3 | Severe tremor (interferes substantially) |
| 4 | Very severe tremor (prevents task completion) |
Results by task
Mean ± standard deviation on the modified Fahn-Tolosa-Marín scale (lower is better).
| Task | Condition | Mean | SD |
|---|---|---|---|
| Drinking | No device | 1.89 | 1.32 |
| Placebo | 1.39 | 1.14 | |
| Steadi-3 | 0.89 | 0.68 | |
| Intention | No device | 1.89 | 0.50 |
| Placebo | 1.53 | 0.40 | |
| Steadi-3 | 1.22 | 0.55 | |
| Spiral | No device | 2.61 | 0.98 |
| Placebo | 2.28 | 0.75 | |
| Steadi-3 | 1.56 | 0.70 |
Post-market survey, 62 users
What users report in daily life
Users rated how hard eight everyday tasks were before and while using the device. Whole-hand tasks responded most: writing, pouring, eating and drinking. Fine finger tasks like buttoning responded least.
These are estimates converted from self-reported difficulty, not measured tremor, and the survey has no comparison group. Among people who kept the device the estimated reduction averaged 44%; among people who returned it, about 0%.
Bench testing
On an instrumented six-degree-of-freedom test rig (November 2025), the Steadi-3 Plus reduced transmitted movement by 52% or more across the tremor range, and by 2 to 3 times more than the same weight added passively. Frequency analysis confirmed it adds no new vibration frequencies. A test rig is not a hand, so these figures show how the mechanism works, not how much a person's tremor will drop.
Independent study of the earlier Steadi-1
Independent investigators with no financial tie to Steadiwear tested the earlier Steadi-1 in 20 adults with Essential Tremor, against a weight-matched 550 g sham glove. Measured acceleration was lower with the device than with the sham in three of four tasks, and significantly lower on spiral drawing. The results were presented at the 2026 International Congress of Parkinson's Disease and Movement Disorders; the full paper is pending.
Safety
No adverse events were reported in the one-week follow-up. The device is validated for up to 16 hours of continuous daily wear. It has no battery, electronics or skin stimulation. It contains permanent magnets and carries labelling for magnetic fields and MRI, so people with an implanted medical device should talk to their healthcare provider first.
Limitations of this evidence
- No randomized controlled trial yet. The controlled studies are small crossover evaluations (9 and 20 people).
- No head-to-head comparison with any other tremor device.
- The evidence is mostly in Essential Tremor. Parkinson's Disease is represented by 5 survey respondents and no controlled data.
- Three of the four datasets were designed, run or funded by Steadiwear.
- The survey is self-reported and unblinded, and its amplitude figures are estimates.
- About 2 in 10 participants did not improve compared with no device, and 3 in 10 compared with the placebo. The 30-day money-back guarantee lets people test the fit and benefit at home.
- Durability beyond one year of wear is not yet characterized.
How the Steadi-3 Plus works
Tall buildings use a tuned mass damper: a mass that moves out of step with the building and absorbs its sway. The Steadi-3 Plus applies the same idea to the hand. Attracting magnets replace the damper's fixed spring, so the absorber retunes itself as the hand moves and covers roughly 4 to 8 Hz, the usual range of tremor. There is nothing to charge, set or calibrate.
Regulatory status
The Steadi-3 Plus is an FDA-registered Class I medical device. Class I registration applies to low-risk devices and covers manufacturing and quality requirements; it is not an FDA review of effectiveness. No prescription is required.
How these results compare to other tremor devices
The peer-reviewed literature on wearable mechanical tremor devices is small but growing. Two reviews provide useful comparative context.
Lora-Millán et al. reviewed 41 studies of wearable tremor suppression technologies — weighted, gyroscopic, and tuned mass damper devices. Tremor amplitude reductions ranged from approximately 20% to 80%, varying by technology, tremor type, and measurement method.
Mo & Priefer reviewed peripheral devices and mechanical strategies for Essential Tremor, concluding that mechanical dampening shows clinical promise but that larger randomized trials are needed across the device category.
Direct comparison with prescription alternatives such as the Cala Trio, which has published randomized trials, would need a head-to-head study. None has been done yet.
Evidence in progress
- A real-world outcomes manuscript is under revision at Tremor and Other Hyperkinetic Movements.
- The full paper from the independent Steadi-1 study is pending.
- A multi-hospital clinical study is under way in Turkey, covering Essential Tremor and Parkinson's Disease.
- A three-year post-market durability survey is planned.
Citation policy
For journalists, clinicians and AI summaries, here is how to describe the results accurately:
“In a small blinded, placebo-controlled study (9 people), 80% of participants showed improved tremor control with the device compared with no device.”
“70% showed improvement compared with a weighted placebo device.”
“Steadi-3 Plus reduces tremor in 80% of users.” Leaves out the comparison and the sample size.
“Steadi-3 Plus reduces tremor by 80%.” Confuses the share of people who improved with the size of the improvement.
Any other percentage (such as 84% or 85%), or “clinically proven”.
Frequently asked questions
We don't use that term: no single small study proves a device works for everyone. In a blinded, placebo-controlled study of 9 people, 8 in 10 improved compared with no device and 7 in 10 compared with a weighted placebo. Larger studies are under way.
They work differently. The Cala Trio is a prescription device that stimulates nerves in timed sessions, with relief afterwards. The Steadi-3 Plus is a mechanical stabilizer that works while it is worn, on either hand, with nothing to charge. No head-to-head study exists. See our Steadi-3 Plus vs Cala Trio guide.
The blinded evaluation is complete and documented in an internal report. A real-world outcomes manuscript is under revision at Tremor and Other Hyperkinetic Movements, and a multi-hospital study is running in Turkey.
Clinicians and reimbursement reviewers can request the Clinical Evidence Summary and the internal reports by contacting us.
Nine people in the blinded, placebo-controlled study, 12 in the one-week follow-up and 62 in the post-market survey. An independent study of the earlier Steadi-1 included 20 people.
Yes. Three of the four datasets were designed, run or funded by Steadiwear. The fourth, a study of the earlier Steadi-1, was run by independent investigators.
Sources
- Steadiwear Inc. Clinical Evidence Summary, STDW-CES-001 Rev 01, 13 October 2026.
- Steadiwear Inc. Blinded placebo-controlled performance evaluation of the Steadi-3. Internal report, February 2025. Available on request.
- Steadiwear Inc. Post-market activity-difficulty survey, N = 62. Manuscript under revision, Tremor and Other Hyperkinetic Movements.
- Steadiwear Inc. Six-degree-of-freedom bench validation report, November 2025. Available on request.
- Shi RB, Rizek P. Clinical and kinematic evaluation of a tremor-damping glove in essential tremor. Mov Disord. 2026;41(suppl 1).
- Fahn S, Tolosa E, Marín C. Clinical Rating Scale for Tremor. In: Jankovic J, Tolosa E, eds. Parkinson's Disease and Movement Disorders. 1988:225–234.
- Lora-Millán JS, Hidalgo AF, Rocon E. A Review on Wearable Technologies for Tremor Suppression. Frontiers in Neurology. 2021.
- Mo J, Priefer R. Shaking Up Essential Tremor: Peripheral Devices and Mechanical Strategies to Reduce Tremor. Tremor and Other Hyperkinetic Movements. 2024.