The Effect of the STIL Orthosis on Action Tremor Severity in People With Parkinson's Disease

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Donders Institute for Brain, Cognition and Behaviour
RECRUITING
Nijmegen
Time Frame
Start Date: 2024-11-19
Estimated Completion Date: 2025-06-01
Participants
Target number of participants: 25
Treatments
Experimental: Baseline-Intervention-Sham
Order of tremor assessments: Baseline \> STIL Orthosis \> Sham
Experimental: Baseline-Sham-Intervention
Order of tremor assessments: Baseline \> Sham \> STIL Orthosis
Sponsors
Leads: Radboud University Medical Center
Collaborators: The Dutch Brain Foundation

This content was sourced from clinicaltrials.gov