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临床试验/NCT05613374
NCT05613374已完成不适用

Virtual Reality-Based Gait Training For Reducing Risk Of Fall in the Elderly.

Umm Al-Qura University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change in the score of fall risk test . (test that assess the change in risk of fall)

研究概览

简要总结

Falling is considered one of the major problems that may affect the elderly, which may lead to bad consequences. Safe walking needs the older adult to anticipate and respond quickly to external demands and sudden environmental changes.Many studies have shown that treadmill training is effective in improving the elderly person's ability to walk and avoid falls. The C-Mill treadmill is an innovative device that recently used for the training of impaired gait and balance.Therefore, this study will aim to evaluate the efficacy of gait training with a virtual reality treadmill on the risk of fall in the elderly.

详细描述

Fall injuries produce serious threats to elderly people. Fall hazards are many, they include physical, psychological, social, and economic consequences. Many studies have shown that walking and balance exercises effectively contribute to enhancing walking performance, improving obstacle avoidance, and reducing the incidence of falls in the elderly. Therefore, the practice of complex and challenging situations of the usual daily walking is very important to prevent falls. Many studies have shown that treadmill training is effective in improving the elderly person's ability to walk and avoid falls. The C-Mill treadmill is recently used for the training of impaired gait and balance. C-Mill applies a virtual reality environment, obstacle avoidance games, and a variety of balance challenges in a safe and controlled environment to increase walking adaptability and improve performance in everyday life.Fall injuries produce serious consequences. The management of these injuries is costly and has a negative impact on healthcare entities. Therefore, prevention programs for preventing and reducing falls among the elderly are very important for reducing these serious consequences. Therefore, this study will compare the efficacy of gait training with a virtual reality treadmill and the conventional physical therapy training program on the risk of fall in the elderly.

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
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •60 healthy older adults, both sexes, will participate in this study. Their ages will be between 60 to 70 years. They should have stable medical status based on a confirmed written medical report signed by their physicians. All participants should not receive other training to improve their balance and gait during the duration of the study application except through this study training program.

排除标准

  • •The exclusion criteria will include any participant with:
  • •a cognitive reduction (< 23 points based on the Mini-Mental State Examination scale;
  • •muscle paralysis,
  • •fixed lower limb bony deformities,
  • •balance deficits,
  • •visual problems,
  • •diabetes mellitus,
  • •polyneuropathy,
  • •gait disorders,
  • •using assistive walking devices during walking,
  • •vertigo, anti-seizures drug use and hypertension,
  • •vestibular and cerebellar problems; and
  • •auditory and perceptual diseases/impairments

研究组 & 干预措施

Control Group

Active Comparator

Participants in the control group will receive conventional functional training (conventional physical therapy program) for one hour as the following.

  • Part (1) Postural reactions exercises. (for 30 minutes)
  • Rest for 15 minutes between the first part and the second part.
  • Part (2) Indoor open environment gait training exercises (over-ground gait training exercises.). (for 30 minutes)

干预措施: Conventional Physical Therapy Program (Other)

Experimental Group

Experimental

Participants in the experimental group will receive a treatment program that is comprised of two parts.

The first part included training, for (30 minutes), on The C-Mill virtual reality treadmill. The C-Mill is an instrumented treadmill with interactive virtual reality games and applications. The C-Mill applies an augmented virtual reality environment, obstacle avoidance games, and a variety of balance challenges in a safe and controlled environment to increase walking adaptability and performance in everyday life.

There will be 15 minutes rest between parts one and two of the training program

The second part (conventional training program) (30 minutes) will include:

  • Postural reactions exercises. ( 20 minutes)
  • Indoor open environment gait training exercises (over-ground gait training exercises.). (10 minutes)

干预措施: The C-Mill virtual reality treadmill (Device)

结局指标

主要结局

Change in the score of fall risk test . (test that assess the change in risk of fall)

时间窗: [Data will be collected at baseline, and 6 weeks after intervention commencement]

The Biodex Balance System was used to assess the Change in the Overall Stability Index of the Fall Risk Test. In this study, the dynamic level (11) will be selected for applying the fall risk test. The result for every child will be registered and compared to the normative data stored in the software of the device based on children age range.

Change in the Overall Stability Index {percentage value (%)}, and Time of Control {seconds} for Limit of Stability Test (test that assess the change in balance ability)

时间窗: [Data will be collected at baseline, and 6 weeks after intervention commencement]

The Biodex Balance System will be used to assess the change in the Overall Stability Index and the Time of Control of the Limit of Stability Test. This test involves measurement of overall directional control which represented as a percentage value (%). The higher scores will indicate better balance control. The test also include measurement of total time required to complete the test (seconds), improvement in this parameter requires minimizing the time recorded to complete the test.

次要结局

  • Change in the Timed Up and Go (TUG) (test that assess the probability for falls among elderly)([Data will be collected at baseline, and 6 weeks after intervention commencement])

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ehab Mohamed Abd El Kafy

Professor of Physical Therapy

Umm Al-Qura University

研究点 (1)

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