Effectiveness of STIL Orthosis in PD

NCT06886178 | Completed

• 1 other identifier: NL86972.091.24
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson&Amp;#39;s Disease; Action Tremor

Keywords

Parkinson's disease; Action tremor; Orthosis

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Secondary Outcomes (5)

• MDS-UPDRS part III tremor items

  Day 1

• Tremor power

  Day 1

• PGI-I

  Day 1

• D-QUEST

  Day 1

• Adverse events

  Day 1

Study Arms (2)

Baseline-Intervention-Sham

EXPERIMENTAL

Order of tremor assessments: Baseline \> STIL Orthosis \> Sham

Device: STIL Orthosis; Device: Sham

Baseline-Sham-Intervention

EXPERIMENTAL

Order of tremor assessments: Baseline \> Sham \> STIL Orthosis

Device: STIL Orthosis; Device: Sham

Interventions

STIL Orthosis DEVICE

STIL Orthosis, a brace for the arm equipped with passive dampening designed to suppress high-frequency movements.

Baseline-Intervention-Sham; Baseline-Sham-Intervention

Sham DEVICE

A version of the STIL Orthosis that is visually indistinguishable from original, but which does not have the passive dampening mechanism.

Baseline-Intervention-Sham; Baseline-Sham-Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• The Dutch Brain Foundation: collaborator

Study Sites (1)

Donders Institute for Brain, Cognition and Behaviour

Nijmegen, Gelderland, 6511EN, Netherlands

Location

MeSH Terms

Conditions

Tremor

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 20, 2025
• Study Start: February 19, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 19, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)