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临床试验/NCT06407726
NCT06407726招募中不适用

Comparative Effects of Virtual Reality and Vestibular Exercises on Balance, Gait, and Activities of Daily Living in Older Adults

Riphah International University2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年5月1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
44
试验地点
2
主要终点
The Dynamic Gait Index (DGI)

研究概览

简要总结

To compare the effects of virtual reality and vestibular exercises on balance, gait, and activities of daily living in older adults.

详细描述

It will be a randomized clinical trial where non-probability convenience sampling technique will be used. Total 44 participants will be taken aged 60 to 85 years. All Participants will be randomized through lottery method and allocated into two groups. Group A (n=22) participants will receive Virtual Reality intervention with conventional treatment, while Group B (n=22) will receive Vestibular Exercises with conventional treatment. The Berg Balance Scale for balance assessment, Dynamic Gait Index for gait while Time Up and Go Test, and Modified Barthel Index for Activities of Daily Living will be outcome measure tools.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
60 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Older adults with or without any assistive device.
  • Participants with a Mini-Mental State Examination score greater than
  • Participants with a value greater than 10 secs on the Time Up and Go Test.

排除标准

  • Severe visual or vestibular impairments (e.g., Meniere's disease, labyrinthitis).
  • Significant musculoskeletal impairments (e.g., arthritis, joint contractures).
  • Unstable medical conditions (e.g., uncontrolled hypertension, cardiovascular disease).
  • History of epilepsy or seizures.

结局指标

主要结局

The Dynamic Gait Index (DGI)

时间窗: 6 months

The Dynamic Gait Index (DGI) is a clinical tool assessing balance during walking under different external conditions. It uses a four-point ordinal scale, with a total score of 24. Scores below 19 indicate a higher risk of falls in older adults, while scores above 22 suggest safe ambulation. The DGI has demonstrated validity as a measure of functional mobility and strongly predicts falls

Berg Balance Scale

时间窗: 6 months

Berg Balance Scale: is a clinical tool assessing static and dynamic balance through 14 functional tasks, each scored from 0 to 4, with a maximum score of 56. Scores below 45 indicate a higher risk of falling. It has demonstrated excellent validity, correlating well with the Timed Up-and-Go test. It also exhibits excellent test-retest reliability, making it a widely accepted tool for measuring balance and mobility.

Modified Barthel Index

时间窗: 6 months

Modified Barthel Index is widely accepted measure of physical disability, assessing activities of daily living. Scoring ranges from 0 to 20, with lower scores indicating increased disability. The total score reflects the patient's independence in daily activities, with changes of more than two points indicating a probable genuine change. The index has demonstrated validity, with scores between 0.73 and 0.77 compared to a motor ability index for stroke patients.It also exhibits high inter-rater and test-retest reliability,Higher scores indicates maximum recovery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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