NCT06886178Completed
Effectiveness of STIL Orthosis in PD
The Effect of the STIL Orthosis on Action Tremor Severity in People With Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 3 Mar 2025
- Start date
- 19 Feb 2025
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Parkinson disease
- NCT number
- NCT06886178
What you commit to
- Study type: Interventional
- Participants enrolled: 25
- From 19 Feb 2025 to the primary completion date, 1 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Having received a botulinum toxin injection to suppress hand tremor in the past six months, or planned in the coming 60 days.
- Previous or planned Deep Brain Stimulation (DBS) at time of study enrollment that interferes with testing.
- Change in any tremor medication in the past 30 days or planned during the period of testing.
Other illness
- 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).
- 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.
- Patch/band-aid allergies.
- Any health condition that in the neurologist's opinion should preclude participation in this study.
Age
- Disease duration of \> 15 years.
Other
- Experiencing severe bradykinesia/rigidity, to such an extent that the participant is unable to perform the ADL tasks (drinking, eating, pouring water).
- 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.
- A hand circumference smaller than 170 mm, or larger than 250 mm.
- An upper arm circumference smaller than 180 mm, or larger than 350 mm.
- Participant is unable to communicate with the investigator and staff due to: (1) not mastering the Dutch and English language, (2) blindness, (3) deafness, (4) illiteracy.
- Pregnancy or anticipated pregnancy at time of study enrollment.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Donders institute for brain, cognition and behaviour Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.