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临床试验/CTRI/2024/10/075731
CTRI/2024/10/075731招募中3 期

Effect of 8 Weeks of Virtual Yoga on Nerve Conduction Parameters, Limits of Stability and Quality of Life in Middle aged people with Diabetic Neuropathy - A Randomized Control Trial

Dipali Khade1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2024年11月1日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
92
试验地点
1
主要终点
1. Nerve Conduction Study

研究概览

简要总结

  1. Participants will be recruited based on the inclusion and exclusion criteria and only after an informed consent is obtained.

  2. Random allocation of participants will be done.

  3. Baseline Assessments would be done followed by grouping as per the allocation and intervention will be started.

  4. Intervention as per the two groups would continue for 8 weeks followed by repeat assessments.

  5. The data obtained would be analyzed and appropriate statistical tests would be applied and based on the results conclusion would be drawn and discussed along with limitations of the study and suggestions for future research.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
40.00 Year(s) 至 59.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed type 2 Diabetes Mellitus at least for or more than 6 months and having Diabetic neuropathy
  • On medical management and referred for physiotherapy
  • HbA1C values equal or less than 8.

排除标准

  • Any other diagnosed neurological /myogenic / acute cardiovascular / systemic / infective / neoplastic disorder
  • Any lower limb or back related musculoskeletal injury or swelling in lower limbs
  • Pregnancy
  • Alcohol addiction
  • Use of any assistive device to maintain balance Active participation in active physical activity like Gym, Aerobics or Yoga asanas in past 6 months
  • Presence of ulcers on lower limbs.

结局指标

主要结局

1. Nerve Conduction Study

时间窗: 1. Baseline measurement taken before starting the interventions | 2. After 8 weeks completion of intervention

2. Limits of stability- Centre of pressure analysis, Single leg stance test and Four square step test

时间窗: 1. Baseline measurement taken before starting the interventions | 2. After 8 weeks completion of intervention

3. SF- 12 quality of life questionnaire

时间窗: 1. Baseline measurement taken before starting the interventions | 2. After 8 weeks completion of intervention

次要结局

  • N/A(N/A)

研究者

发起方
Dipali Khade
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dipali Khade

K J Somaiya College of Physiotherapy

研究点 (1)

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