Dystonic tremor, tremor associated with dystonia, trembling
Conditions
Interventions
 
The device being tested in this study is the STIL Orthosis. The STIL Orthosis is designed to make the forearm more stable while performing daily tasks. It is a passive, non-invasive orthosis specifica
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Participant is at least 18 years of ageDiagnosed with dystonic tremor by a movement disorder expertAction and/or intention tremor in one or both armsExperiences at least tremor of wrist flexion/extension or forearm pronation/supination
Exclusion criteria
Exclusion criteria: Diagnosed with a tremor other than dystonic (e.g., essential tremor, functional tremor and Parkinson’s disease or the presence of Parkinsonian features)Diagnosed with a condition other than dystonic tremor that results in limited muscle function or movement in the arm/hand (e.g., contractures)Any health condition that in the neurologist’s opinion should preclude participationBotulinum toxin injection for hand tremor within 3 months prior to study enrolmentPrevious or planned deep brain stimulation (DBS) at the time of study enrolment that interferes with measurementsPrevious or planned thalamotomy procedure, including stereotactic thalamotomy, gamma knife radiosurgical thalamotomy and focused ultrasound for treatment of tremor at the time of study enrolment interfering with measurementsChange in medication related to tremor in the 30 days prior to study enrolmentAlcohol consumption within 10 hours prior to study participationCaffeine consumption within 10 hours prior to study participationSevere physical exercise within 10 hours prior to study participationSwollen, infected, inflamed areas, skin eruptions, open wounds or cancerous lesions of the skin on the forearm or hand that would wear the orthosis during the measurementHand circumference less than 170 mm or greater than 250 mmUpper arm circumference less than 180 mm or greater than 350 mmPatch/band-aid allergySilver allergyPacemakerPregnancy or anticipated pregnancy at time of study enrolmentNo understanding of the Dutch or English language
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical tremor severity is assessed qualitatively using a tremor rating scale (TETRAS) in both the baseline condition without orthosis and the intervention condition with orthosis. Tremor is assessed on ten selected tasks (postural outstretched arms with palms up, postural outstretched arms with palms down, postural wingbeat, finger-to-nose, finger tapping, eating, drinking, pouring, drawing) representative of everyday tasks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Tremor power is assessed quantitatively in the same ten tasks and two conditions as tremor severity by using polymyography. This includes accelerometry, which captures motion data, and surface electromyography (sEMG), whichs capture muscle activity.Patient satisfaction is evaluated with a subset of the Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology (D-QUEST). To account for the potentially accompanying role of dystonia in tremor severity, dystonia will be clinically assessed using a dystonia rating scale (BFMDRS) in the same ten tasks and two conditions. | — |
Countries
Netherlands
Contacts
Public ContactH. Eggink
Universitair Medisch Centrum Groningen
Outcome results
None listed