Parkinson&Amp;#39;s DiseaseSTIL-PDNCT06886178
Effectiveness of STIL Orthosis in PD
A study testing STIL Orthosis in people with Parkinson&Amp;#39;s Disease and Action Tremor, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson&Amp;#39;s Disease, Action Tremor
- What is being tested?
- STIL Orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Feb 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
- 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.
- Patch/band-aid allergies.
- 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.
- Any health condition that in the neurologist's opinion should preclude participation in this study.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Donders Institute for Brain, Cognition and Behaviour
Nijmegen, Gelderland, 6511EN
About this study
Official title: The Effect of the STIL Orthosis on Action Tremor Severity in People With Parkinson's Disease
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?
Read more
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.
Read the detailed description
- <b>Background</b>: Tremor is a common symptom in people with Parkinson's disease (PD), affecting 75% of patients. While PD tremor usually occurs at rest, 46-93% of patients also have action tremor. Action tremor often does not respond to dopaminergic medication, and stereotactic surgery is invasive and unsuitable for many patients. By interfering with daily activities, action tremor can reduce independence and quality of life, necessitating new treatments.
- <b>STIL Orthosis</b>: The STIL Orthosis, a CE-certified device, aims to reduce tremor by dampening wrist flexion-extension and forearm pronation-supination. It features dampeners that limit high-frequency movements, such as tremor, while maintaining voluntary movements. In patients with essential tremor (n=24), the STIL Orthosis reduced action tremor severity during daily activities by 65-87% compared to baseline. This suggests that it could be a promising treatment for PD action tremors.
- <b>Design</b>: In this study, 25 PD patients will be recruited to test whether the STIL Orthosis can be used to treat PD-related action tremor. Action tremor will be measured under three conditions: while wearing the STIL Orthosis (intervention), while wearing an orthosis without dampening (sham), and while wearing no orthosis (baseline). Severity of action tremor in all conditions will be assessed using the TETRAS scale.
- <b>Primary outcome</b>: The primary outcome of this study is action tremor severity, measured using the <b>TETRAS scale</b>. The main study endpoint is the <b>difference in TETRAS scores between two conditions (intervention vs. sham and intervention vs. baseline)</b>.
- <b>Secondary outcomes</b>: As secondary outcomes, we will measure tremor severity using the MDS-UPDRS part III scale, focusing on items related to postural, kinetic, and rest tremor (3.15, 3.16, 3.17). We will also measure tremor power using surface electromyography (sEMG) and accelerometry. Furthermore, we will assess perceived change in tremor using the PGC-I, user satisfaction on relevant items from the D-QUEST, and product safety using an adverse events report form.
- <b>Sample size calculation</b>: The sample size calculation is based on a pilot study with 8 Parkinson's disease patients experiencing action tremor in the forearm, which showed an effect size of 1.24 1.86 for MDS-UPDRS part 3 (tremor items 3.15, 3.16, and 3.17) and 2.21 for TETRAS. Given that patients only benefit from a device that has a large effect on their tremor, an effect size <b>Cohen's d=0.8</b> was chosen, which is also common practice in the medical literature. In total, two main comparisons will be done on the primary outcome (TETRAS score): intervention vs. sham, intervention vs. baseline. To adjust for multiple statistical tests, a Bonferroni correction of <b>alpha = 0.05/2 = 0.025</b> is used. To achieve <b>80% power in a two-sided paired t-test</b>, a minimum of <b>18 patients</b> needs to be included. In order to compensate for possible drop-outs, 25 patients will be included for this clinical investigation.
- <b>Statistical analysis</b>: All analyses will follow the intention-to-treat principle. Paired-samples t-test will be used to test for intervention-related effects on action tremor severity. In the event that tremor severity scores are not normally distributed, Wilcoxon signed rank tests will be used instead.
- Conditions
- Parkinson&Amp;#39;s Disease, Action Tremor
- Being tested
- STIL Orthosis, Sham
- Keywords
- Parkinson&#39;s disease, Action tremor, Orthosis
- Medical subject headings
- Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STIL OrthosisDevice
STIL Orthosis, a brace for the arm equipped with passive dampening designed to suppress high-frequency movements.
ShamDevice
A version of the STIL Orthosis that is visually indistinguishable from original, but which does not have the passive dampening mechanism.
| Study group | Role | What they receive |
|---|---|---|
| Baseline-Intervention-Sham | Experimental | Order of tremor assessments: Baseline > STIL Orthosis > Sham Receives: Device: STIL Orthosis; Device: Sham |
| Baseline-Sham-Intervention | Experimental | Order of tremor assessments: Baseline > Sham > STIL Orthosis Receives: Device: STIL Orthosis; Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
TETRAS
Tremor severity is assessed using the Tremor Research Group Essential Tremor Rating Scale (TETRAS), which is a validated scale specifically designed for essential tremor, the most common action tremor worldwide.
TETRAS will be rated by two independent assessors, based on a video recording. The scale covers 7 postural and kinetic tasks (postural outstretched arms, postural wing beating, finger-to-nose maneuver, eating, drinking, pouring, Archimedes spiral), which are selected to accurately represent the difficulties that PD patients experience with per-forming ADL tasks. A TETRAS score is rated on the baseline, and for the sham and STIL Orthosis conditions. Tremor is rated on a 0 to 4 scale per task, with 0 indicating no visible tremor and 4 indicating a tremor with an amplitude exceeding 20 cm. Combining the 7 tasks from the TETRAS scale, a maximum sum score of 28 points can be achieved per condition.
Measured: Day 1
Secondary outcomes (5)
MDS-UPDRS part III tremor items
Tremor severity is also assessed using the MDS-UPDRS part III scale. Items 15, 16, and 17, of the MDS-UPDRS part III for postural, kinetic, and rest tremor will be used for assessment of the arm, respectively. Tremor is rated on a 5-point scale, with 0 indicating no tremor and 4 indicating a tremor with an amplitude of at least 10 cm. Note that the tasks for this rating are distinct from the TETRAS scale.
Measured: Day 1
Tremor power
Quantification of tremor power will be based on movement data from accelerometry and using surface electromyography (sEMG). Again, the same 7 tasks (postural out-stretched arms, postural wing beating, finger-to-nose manoeuvre, eating, drinking, pour-ing, Archimedes spiral) and resting posture are used to compare baseline, sham and in-tervention conditions. Tremor power is obtained through signal processing.
Measured: Day 1
PGI-I
Perceived change in tremor while wearing the sham and STIL Orthosis, using the Patient Global Impression of Improvement (PGI-I) scale. This questionnaire is a single-item scale that measures a patient's perception of improvement or deterioration in their condition following treatment. Answers range from 'very much improved' to 'very much wors-ened'.
Measured: Day 1
D-QUEST
User satisfaction is evaluated with a subset of the Dutch Quebec User Evaluation of Satisfaction with Assistive Technology (D-QUEST) (Demers et al., 2001 \& 2002). This questionnaire consists of 8 questions regarding comfort and usability of the device itself and 5 questions about the service of the manufacturer. Only 4 questions about satisfaction of the device itself will be questioned. Satisfaction is measured on a 1-5 scale, ranging from 'completely not satisfied' to 'very satisfied'. Additional questions regarding comfort will be asked to examine possible adverse-effects more detailed.
Measured: Day 1
Adverse events
Product safety will be assessed using the Dutch version of NCCIH's Adverse Events Report Form. This form is used to report the severity, relationship to the study, taken action, outcome of the (S)AE and whether it was expected or not.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start19 Feb 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson&Amp;#39;s DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- The Dutch Brain Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886178
- Sponsor's protocol ID
- NL86972.091.24
- Acronym
- STIL-PD
- Status last verified
- Feb 2025
- First submitted
- 3 Mar 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared with other research sites upon approval of reasonable requests.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the STIL Orthosis on Action Tremor Severity in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06886178
- Acronym / sponsor ID
- STIL-PD / NL86972.091.24
- Conditions
- Parkinson&Amp;#39;s Disease, Action Tremor
- Keywords
- Parkinson&#39;s disease, Action tremor, Orthosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- The Dutch Brain Foundation
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- <b>Background</b>: Tremor is a common symptom in people with Parkinson's disease (PD), affecting 75% of patients. While PD tremor usually occurs at rest, 46-93% of patients also have action tremor. Action tremor often does not respond to dopaminergic medication, and stereotactic surgery is invasive and unsuitable for many patients. By interfering with daily activities, action tremor can reduce independence and quality of life, necessitating new treatments.
- <b>STIL Orthosis</b>: The STIL Orthosis, a CE-certified device, aims to reduce tremor by dampening wrist flexion-extension and forearm pronation-supination. It features dampeners that limit high-frequency movements, such as tremor, while maintaining voluntary movements. In patients with essential tremor (n=24), the STIL Orthosis reduced action tremor severity during daily activities by 65-87% compared to baseline. This suggests that it could be a promising treatment for PD action tremors.
- <b>Design</b>: In this study, 25 PD patients will be recruited to test whether the STIL Orthosis can be used to treat PD-related action tremor. Action tremor will be measured under three conditions: while wearing the STIL Orthosis (intervention), while wearing an orthosis without dampening (sham), and while wearing no orthosis (baseline). Severity of action tremor in all conditions will be assessed using the TETRAS scale.
- <b>Primary outcome</b>: The primary outcome of this study is action tremor severity, measured using the <b>TETRAS scale</b>. The main study endpoint is the <b>difference in TETRAS scores between two conditions (intervention vs. sham and intervention vs. baseline)</b>.
- <b>Secondary outcomes</b>: As secondary outcomes, we will measure tremor severity using the MDS-UPDRS part III scale, focusing on items related to postural, kinetic, and rest tremor (3.15, 3.16, 3.17). We will also measure tremor power using surface electromyography (sEMG) and accelerometry. Furthermore, we will assess perceived change in tremor using the PGC-I, user satisfaction on relevant items from the D-QUEST, and product safety using an adverse events report form.
- <b>Sample size calculation</b>: The sample size calculation is based on a pilot study with 8 Parkinson's disease patients experiencing action tremor in the forearm, which showed an effect size of 1.24 1.86 for MDS-UPDRS part 3 (tremor items 3.15, 3.16, and 3.17) and 2.21 for TETRAS. Given that patients only benefit from a device that has a large effect on their tremor, an effect size <b>Cohen's d=0.8</b> was chosen, which is also common practice in the medical literature. In total, two main comparisons will be done on the primary outcome (TETRAS score): intervention vs. sham, intervention vs. baseline. To adjust for multiple statistical tests, a Bonferroni correction of <b>alpha = 0.05/2 = 0.025</b> is used. To achieve <b>80% power in a two-sided paired t-test</b>, a minimum of <b>18 patients</b> needs to be included. In order to compensate for possible drop-outs, 25 patients will be included for this clinical investigation.
- <b>Statistical analysis</b>: All analyses will follow the intention-to-treat principle. Paired-samples t-test will be used to test for intervention-related effects on action tremor severity. In the event that tremor severity scores are not normally distributed, Wilcoxon signed rank tests will be used instead.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baseline-Intervention-Sham | Experimental | Device: STIL Orthosis, Device: ShamOrder of tremor assessments: Baseline > STIL Orthosis > Sham |
| Baseline-Sham-Intervention | Experimental | Device: STIL Orthosis, Device: ShamOrder of tremor assessments: Baseline > Sham > STIL Orthosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STIL OrthosisSTIL Orthosis, a brace for the arm equipped with passive dampening designed to suppress high-frequency movements. | Device | Baseline-Intervention-Sham, Baseline-Sham-Intervention |
| ShamA version of the STIL Orthosis that is visually indistinguishable from original, but which does not have the passive dampening mechanism. | Device | Baseline-Intervention-Sham, Baseline-Sham-Intervention |
Primary outcome
TETRAS
Time frame: Day 1
Tremor severity is assessed using the Tremor Research Group Essential Tremor Rating Scale (TETRAS), which is a validated scale specifically designed for essential tremor, the most common action tremor worldwide. TETRAS will be rated by two independent assessors, based on a video recording. The scale covers 7 postural and kinetic tasks (postural outstretched arms, postural wing beating, finger-to-nose maneuver, eating, drinking, pouring, Archimedes spiral), which are selected to accurately represent the difficulties that PD patients experience with per-forming ADL tasks. A TETRAS score is rated on the baseline, and for the sham and STIL Orthosis conditions. Tremor is rated on a 0 to 4 scale per task, with 0 indicating no visible tremor and 4 indicating a tremor with an amplitude exceeding 20 cm. Combining the 7 tasks from the TETRAS scale, a maximum sum score of 28 points can be achieved per condition.
5 secondary outcomes
MDS-UPDRS part III tremor items
Time frame: Day 1
Tremor power
Time frame: Day 1
PGI-I
Time frame: Day 1
D-QUEST
Time frame: Day 1
Adverse events
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Yes. Data will be shared with other research sites upon approval of reasonable requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STIL Orthosis in people with Parkinson&Amp;#39;s Disease and Action Tremor, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TETRAS (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.