CompletedNot Applicable

Effectiveness of STIL Orthosis in PD

Netherlands25 participantsStarted 2025-02-19

Plain-language summary

Parkinson's disease is a neurodegenerative condition that leads to uncontrollable shaking (tremor), which can substantially impair everyday activities. The goal of this clinical trial is to learn if the STIL Orthosis works as a treatment option for tremor in people with Parkinson's disease. The main questions it aims to answer are: * Does the STIL Orthosis reduce tremor? * Are users satisfied with the usability and comfort of the STIL Orthosis? * Does the STIL Orthosis have any adverse effects? Participants' tremor will be measured during three conditions: * While wearing the STIL Orthosis * While wearing an orthosis without dampening (sham) * While wearing no orthosis (baseline) Researchers will compare the severity of tremor while wearing the STIL Orthosis against tremor during sham and baseline.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participant is at least 18 years of age. * Willing to sign the informed consent. * Diagnosed with Parkinson's disease by a neurologist or movement disorders specialist. * Action tremor in one or two arms (clinical severity score of at least 2 on their dominant side, on MDS-UPDRS items 3.15 or 3.16). * At least experiencing wrist flexion/extension or forearm pronation/supination tremor. Exclusion Criteria: * Diagnosed with any other neurological disorder, such as epilepsy, Essential tremor, functional tremor, physiologic tremor, cerebellar tremor, MS, spasticity, ataxia, dystonia, Alzheimer's disease or dementia, atypical parkinsonism, peripheral neuropathy affecting the arms (e.g., carpal tunnel syndrome). * Disease duration of \> 15 years. * Experiencing severe bradykinesia/rigidity, to such an extent that the participant is unable to perform the ADL tasks (drinking, eating, pouring water). * Limited movement or muscle function in the arm/hand (for contractures or muscle diseases), or loss of muscle function in one arm (e.g., due to paralysis, or amputation). * Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin on the forearm or hand that would wear the orthosis during the clinical investigation. * Consuming excessive alcohol (more than 21 glasses per week for men and 14 glasses per week for women), as defined in the GGZ guidelines on alcohol use. * Having received a botulinum toxin injection to suppress h…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial tested a device called the STIL orthosis for action tremor in Parkinson's disease — is this type of wearable tremor-suppressing device something that might be appropriate to discuss for my situation, given my specific tremor symptoms?
2The trial measured outcomes using something called TETRAS, which assesses tremor severity — can you explain what that scale measures and whether my tremor would be considered significant enough to benefit from a device like the one studied here?
3Since this trial is already completed, has the results data been published or presented anywhere, and can we look at what the findings actually showed about how well the STIL orthosis worked?
4Because this study was categorized as 'Phase NA,' meaning it wasn't a standard drug-phase trial, what does that tell us about how confident we can be in the safety and effectiveness of the STIL orthosis compared to more established tremor treatments for Parkinson's?
5Are there other non-medication or non-surgical options for managing action tremor in Parkinson's disease that I should consider alongside or instead of a device like the one in this trial?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

TETRAS

Timeframe: Day 1

Trial details

NCT IDNCT06886178

SponsorRadboud University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

View on ClinicalTrials.gov More Parkinson&Amp;#39;s Disease trials