Wearable device to assess tremors in Parkinsonism Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
Assessment of Tremors in Parkinsonism Patients Using a Wearable Sensor Device is a prospective observational single arm cross sectional validation study with longitudinal follow up. The study aims to validate wearable sensor tremor measurements against clinician rated MDS UPDRS tremor scores and to evaluate the reliability, responsiveness, and feasibility of device derived metrics over time. Primary assessment will be agreement between device metrics and clinical scores at Day 1, Day 30, and Day 90. Secondary assessments include responsiveness to medication changes, test retest reliability, feasibility of device use, diagnostic accuracy, and stability of tremor burden. The study includes adults aged 18 to 80 years with clinically diagnosed Parkinsonism and detectable tremor, and excludes those with interfering movement disorders, implanted devices, severe cognitive impairment, unstable illness, or inability to attend follow up visits. A total of 80 participants will be enrolled with an expected 60 completing the Day 90 visit. Total duration is approximately nine to eleven months.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Clinically diagnosed Parkinsonism idiopathic Parkinsons disease or other Parkinsonian syndromes 2 Presence of rest postural or action tremor on clinical examination 3 Able to undergo wearable device recording and UPDRS assessment during the study visit 4 Able to provide informed consent.
排除标准
- •1 Presence of other movement disorders that may interfere with tremor assessment such as severe chorea dystonia with prominent irregular movements essential tremor without Parkinsonism 2 Patients with implanted electronic devices that may interfere with sensor function such as deep brain stimulator not in stable mode 3 Severe cognitive impairment or inability to follow instructions 4 Acute medical illness preventing participation 5 Dermatological or musculoskeletal conditions that preclude safe placement of wearable sensors 6 Inability or unwillingness to participate in followup for secondary outcomes.
研究者
DR GOWTHAM GANAPATHY
SAVEETHA MEDICAL COLLEGE AND HOSPITAL