The effect of a novel anti-tremor orthosis on reduction of forearm tremor in essential tremor patients - a single-blind randomized crossover study

Reinier de Graaf Hospital0 个研究点目标入组 24 人开始时间: 2023年5月30日最近更新: 2023年11月28日

试验速览

暂无简介。

•1. Diagnosed with essential tremor
•2. Substantial perceived disability due to tremor in the arm, assessed from Bain and Findley ADL score (>30)
•3. Tremor severity score >13 on subset (ADL tasks and upper-limb tasks) of the TETRAS scale
•4. Dominant wrist flexion-extension and forearm pronation-supination tremor
•5. Above 18 years old

•1. Dominant shoulder internal-external rotation tremor
•2. Dominant elbow flexion-extension tremor
•3. Excessive alcohol consumption, as defined in the Dutch GGZ guidelines on alcohol use
•4. Previous or planned deep brain stimulation (DBS) at the time of study enrollment that interferes with testing
•5. Previous or planned thalamotomy procedure, including stereotactic thalamotomy, gamma knife radio surgical thalamotomy, and focused ultrasound for the treatment of tremor at the time of study enrollment that interferes with testing
•6. Change in medications related to tremor disorder in the 30 days prior to study enrollment
•7. Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin on the forearm or hand that would interfere with wearing the orthosis during the clinical investigation
•8. Peripheral neuropathy affecting the tested upper extremity (e.g. carpal tunnel syndrome)
•9. The suspicion or confirmation that head tremor may cause impairment in performing ADL tasks
•10. Diagnosed Parkinson’s disease, this includes the presence of parkinsonian features
•11. Diagnosed functional tremor
•12. Diagnosed physiologic tremor
•13. Diagnosed cerebellar tremor
•14. Diagnosed multiple sclerosis (MS)
•15. Diagnosed ataxia
•16. Patients with an amputation of one or both upper extremities.
•17. Subjects with restricted movement or restricted muscle function in the arm and or hand (e.g. contractures)

发起方

Reinier de Graaf Hospital