invalidating forearm tremor shaky hands
Conditions
Interventions
The intervention is the STIL brace that suppresses the tremor in the active
mode. In this condition, different movements and postures are performed with
the hand/arm during which the tremor amplitud
Sponsors
Reinier de Graaf Groep
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study is tremor amplitude, measured with accelerometry sensors with gyro on the hand and the arm. The tremor amplitude will be compared over the three situations (without brace, with active brace and with passive brace). We expect a tremor amplitude reduction of at least 50% with brace suppression compared to the situation without brace. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are: - Subjective severity of the tremor, measured with the Patient Global Impression of Severity (PGI-S) - Patient satisfaction with regards to the brace, measured with the Dutch version of the Quebec User Evaluation of Satisfaction with Assistive Technology (D-QUEST) and an extra questionnaire developed by STIL to get more specific feedback on the brace. | — |
Countries
Netherlands
Outcome results
None listed