跳至主要内容
临床试验/CTRI/2020/12/029865
CTRI/2020/12/029865招募中不适用

Randomized control trial to study the effect of yoga on neurological function, Quality of life, Biomarker and Imaging of ALS patients.

Department of Science and Technology1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年12月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Motor power

研究概览

简要总结

Amyotrophic lateral Sclerosis is a neurodegenerative disease of motor neurons and has poor therapeutic options with relentless progressive clinical course with severe disability and eventually mortality. Iyenger Yoga has been shown to have some effect on cramps in these group of patients. Preliminary data from our ALS registry patients have shown that few patients who are advised for Yoga and meditation do relatively well with motor, quality of life scales and cramps and fasciculations. This present trial would have a detailed and extensive study, to assess the effect of Yoga in ALS patients on neurological functions, quality of life, imaging and studied biomarker. ALS patients would be randomized by computer generated method to group patients into yoga and non-yoga group and would be assessed to compare the outcome at regular intervals of 0 and 6 months.Neurofilament light chain from serum of  yoga and control group patients along with their DTI brain sequences will be evaluated at 0 and 06 months time interval. The results would be independently assessed by an blinded assessor at the end of the study.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •All consecutive ALS patients (diagnosed as per Awaji Shima Criteria 2008, definite, probable and possible) visiting the Neurology OPD or admitted in Neurology ward will be included in the study.
  • •Patient consenting for the study.

排除标准

  • •Patients unable to perform the yoga and meditation exercises.
  • •Patients not consenting to the study.
  • •ALS with dementia (FTD-ALS) Previous history of any dementia or any strokes in the past.

结局指标

主要结局

Motor power

时间窗: 6 months

次要结局

  • Any effect on Neurofilament light Chain(6 months)
  • Any effect on Quality of Life(6 months)

研究者

申办方类型
Government funding agency

研究点 (1)

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