The effect of the STIL brace on forearm tremor - a double-blind randomized crossover study

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

* Patients over 18 years old
* Competent and willing to sign informed consent
* Significant disability due to forearm tremor. (ADL score of 3 or above in one
of the upper limb items and a minimum subset score of 38 across all upper limb
items. Scored for the most affected hand with the Bain and Findley ADL scale)

Exclusion Criteria

* Excessive alcohol consumption, as defined in the GGZ guidelines
* Implanted electrical medical device, such as a pacemaker, defibrillator, or
deep brain stimulator
* Previous thalamotomy procedure, including stereotactic thalamotomy, gamma
knife radio surgical thalamotomy, and focused ultrasound for the treatment of
tremor
* Change in medication in the 30 days prior to study enrollment
* Taking medication known to exacerbate tremor
* Suspected or diagnosed epilepsy
* Swollen, infected, inflamed areas, or skin eruptions, open wounds, or
cancerous lesions of skin at stimulation site.
* Peripheral neuropathy affecting the tested upper extremity (e.g. Carpal
tunnel syndrome)
* Presence of any other neurodegenerative diseases like multisystem atrophy,
progressive supranuclear palsy, dementia with Lewy bodies, and Alzheimer's
disease.
* Patients diagnosed with a depression
* Patients with an amputation of one or both upper extremities.
* Subjects with a restricted movement of the arm and or hand (e.g.
contractures) or restricted muscle function
* Botulinum toxin injection for hand tremor within 6 months prior to study
enrollment
* Alcohol or caffeine consumption within 24 hours of study enrollment.
* Heavy physical training within 24 hours of study enrollment
* Subjects unable to communicate with the investigator and staff
* Subjects with illiteracy
* Pregnancy at time of study enrollment

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of this study is tremor amplitude, measured with<br /><br>accelerometry sensors with gyro on the hand and the arm. The tremor amplitude<br /><br>will be compared over the three situations (without brace, with active brace<br /><br>and with passive brace). We expect a tremor amplitude reduction of at least 50%<br /><br>with brace suppression compared to the situation without brace.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are:<br /><br>- Subjective severity of the tremor, measured with the Patient Global<br /><br>Impression of Severity (PGI-S)<br /><br>- Patient satisfaction with regards to the brace, measured with the Dutch<br /><br>version of the Quebec User Evaluation of Satisfaction with Assistive Technology<br /><br>(D-QUEST) and an extra questionnaire developed by STIL to get more specific<br /><br>feedback on the brace. </p><br>