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临床试验/NL-OMON51742
NL-OMON51742已完成不适用

The effect of the STIL anti-tremor orthosis on reduction of forearm tremor in Essential Tremor patients - a single blind randomized crossover study - Suppression of forearm tremor with the STIL anti-tremor orthosis

Reinier de Graaf Groep0 个研究点目标入组 25 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • - Diagnosed with Essential Tremor
  • - Significant disability due to forearm tremor, retrieved from Bain and Findley
  • ADL score (>30)
  • - Tremor severity score >13 on subset of TETRAS scale
  • - Dominant wrist flexion/extension and forearm pronation/supination tremor
  • - > 18 years old

排除标准

  • Dominant shoulder internal/external rotation tremor
  • Dominant elbow flexion/extension tremor
  • Excessive alcohol consumption, as defined in the GGZ guidelines on alcohol
  • Previous or planned Deep Brain Stimulation (DBS) at time of study enrollment
  • that interferes with testing.
  • Previous or planned thalamotomy procedure, including stereotactic
  • thalamotomy, gamma knife radio surgical thalamotomy, and focused ultrasound for
  • the treatment of tremor at time of study enrollment that interferes with
  • Change in medications related to tremor disorder in the 30 days prior to
  • study enrollment
  • 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.
  • Peripheral neuropathy affecting the tested upper extremity (e.g. Carpal
  • tunnel syndrome)
  • The suspicion or confirmation that head tremor may cause impairment in
  • performing ADL tasks
  • Diagnosed Parkinson*s disease, this includes presence of parkinsonian features
  • Diagnosed functional tremor
  • Diagnosed physiologic tremor
  • Diagnosed cerebellar tremor
  • Diagnosed Multiple Sclerosis (MS)
  • Diagnosed ataxia
  • Patients with an amputation of one or both upper extremities.
  • Subjects with a restricted movement or restricted muscle function in the arm
  • and or hand (e.g. contractures)

研究者

发起方
Reinier de Graaf Groep

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