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临床试验/CTRI/2025/10/096209
CTRI/2025/10/096209尚未招募不适用

Effect of dual task training versus head mounted virtual reality on strength balance and quality of life in elderly a randomized clinical trial

KLEs Dr Prabhakar Kore Hospital and Medical Research Centre1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年10月28日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
36
试验地点
1
主要终点
Berg Balance Scale

研究概览

简要总结

This study is a 6-month prospective, parallel-group, Randomized Clinical Trial RCT designed to compare the effects of conventional Dual-Task Training versus Head-Mounted Virtual Reality HMD-VR on lower limb strength, balance, and quality of life in elderly participants. A minimum of 36 participants (18 per group), aged over 60, will be recruited from Old Age Homes in Belagavi, India. Participants will be randomized into two arms: Group A will receive Conventional Dual-Task Training (balance exercises combined with cognitive tasks) and Group B will receive HMD-VR (balance-focused games using a VR device). Both interventions will be delivered for 45 minutes per session, two days per week for 6 weeks. The primary outcomes Lower Limb Strength (Modified 30s Sit-Stand Test), Balance (Berg Balance Scale), and Quality of Life (WHOQOL-BREF) will be measured at baseline and post-intervention. Statistical analysis will involve Paired t tests (or Wilcoxon signed rank test) and Independent samples t test (or Mann Whitney U test) for group comparisons, with a p value less than 0.05 considered significant.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
65.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Participants must be of all genders, over 60 years of age, and willing to provide informed consent and complete all trial procedures.
  • Functional mobility is required, specifically the ability to ambulate at least 10 meters without using an assistive device.
  • Cognitive eligibility is defined by a Mini-Mental State Examination (MMSE) score of 24 or greater.
  • Furthermore, all included participants must exhibit a degree of balance impairment, defined by a Berg Balance Scale (BBS) score between 21 and 56, covering both mild impairment (BBS 41 to 56) and moderate impairment (BBS 21 to 40).

排除标准

  • Individuals with recent fractures, lower limb injuries and surgeries (past 6 months).
  • Any diagnosed case of respiratory , neurological or cardiovascular condition.
  • Severe visual impairment not correctable with lenses, or vestibular disorder producing instability.

结局指标

主要结局

Berg Balance Scale

时间窗: 0-6 Weeks

WHOQOL-BREF

时间窗: 0-6 Weeks

Modified 30s sit- stand test

时间窗: 0-6 Weeks

次要结局

  • Nill(Nill)

研究者

发起方
KLEs Dr Prabhakar Kore Hospital and Medical Research Centre
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Rutuja Dudhane

Dr Prabhakar Kore Hospital and Medical Research Centre

研究点 (1)

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