involuntary movements, Shaking
Conditions
Interventions
The device that will be tested in this study is the STIL Orthosis. This non-invasive passive device uses the principle of applying external joint damping as its working principle. Two types of dampers
high frequency involuntary motion, leaving low impact on voluntary motion, to passively suppress the forearm tremor.
A sham device is used to investigate and eliminate the influence of the weight of t
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Participant is at least 18 years of age. - Willing to sign the informed consent. - Diagnosed with Parkinson's disease by a neurologist. - 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
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 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: - Not mastering the Dutch and English language. - Blindness. - Deafness. - Subjects with 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantification of tremor severity will be based on the TETRAS scale, from which 7 tasks (postural out-stretched arms, postural wingbeat, finger-to-nose, eating, drinking, pouring, writing) are selected that justly represent the obstruction that PD patients experience in daily life. A TETRAS score is rated on the baseline, sham and intervention conditions. Combining the 7 tasks from the TETRAS scale, a maximum scoring of 28 points can be achieved per condition. The expectation is that orthosis will reduce TETRAS score by at least on categorial measure (e.g. from severe to moderate). | — |
Secondary
| Measure | Time frame |
|---|---|
| Tremor severity reduction is also assessed using the MDS-UPDRS scale, focusing on items related to postural, kinetic, and rest tremor. 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. The endpoint is the change in MDS-UPDRS score between the interventions. Tremor power is measured using an accelerometer placed on the hand and surface electromyography (sEMG). Tremor power is obtained through signal processing and compared between interventions. Patient satisfaction is evaluated with the PGI-I and a subset of the D-QUEST questionnaire, capturing subjective improvement perceived by the patient. Adverse effects observed by the investigator are documented in an (S)AE report form. | — |
Countries
Netherlands
Contacts
Public ContactL.C. Schinkel
Radboud Universitair Medisch Centrum
Outcome results
None listed