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临床试验/NCT05623462
NCT05623462已完成不适用

Virtual Reality Treadmill Training for Improving Gait Performance in the Elderly

Umm Al-Qura University1 个研究点 分布在 1 个国家目标入组 40 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
40
试验地点
1
主要终点
Change in the gait parameter (stride length) (This parameter indicated the change of gait performance).

研究概览

简要总结

Safe walking needs the older adult to anticipate and respond quickly to external demands and sudden environmental changes. The practice of complex and challenging situations of the usual daily walking is very important to prevent balance loss and falls in the elderly.

Researchers reported that subjects trained in a virtual environment with enhanced feedback performed walking skills better than those trained with conventional methods. The C-Mill treadmill is an innovative device that was recently used for the training of impaired gait and balance. C-Mill treadmill uses virtual reality, augmented feedback, and force plate technology that provides the best solution for efficient functional movement therapy. Therefore, this study will evaluate the efficacy of gait training with a virtual reality treadmill on walking abilities in elderly people.

详细描述

Many studies have shown that walking exercises effectively contribute to enhancing walking performance in the elderly. Several studies have shown that treadmill training is effective in improving the elderly person's ability to walk. Therefore, the practice of complex and challenging situations of the usual daily walking is very important to improve walking. Unfortunately, older adults have few opportunities to practice safe walking well and consistently in a task-specific manner.

There are many studies that have shown that gait training in a challenging environment, such as walking on a treadmill, is more effective in improving the elderly person's ability to walk properly, compared to the traditional training exercise regimen that relies on training in closed training environment free from challenges and obstacles.

Virtual reality technology is one of the advanced technologies used in physical therapy and rehabilitation. This technology contributes to creating an interactive environment for the trainees that enables them to integrate into the training process and encourages them to perform controlled motor tasks. C-Mill treadmill applies a virtual reality environment, dual-tasking exercises, obstacle avoidance games, and a variety of gait challenges in a safe and controlled environment to increase walking adaptability and improve performance in everyday life. Many studies found that the C-Mill treadmill is effective in improving gait performance and adaptability in clinical practice Therefore, this study will compare the efficacy of gait training with a virtual reality treadmill and the conventional physical therapy program on walking abilities in elderly people.

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
65 Years 至 75 Years(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •40 healthy older adults, both sexes, will participate in this study. Their ages will be between 65 to 75 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 gait training (conventional physical therapy program) for one hour as the following.

  • Part (1) Treadmill gait training without virtual reality. (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: Indoor open environment gait training exercises (over-ground gait training exercises.). (30 minutes)

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

结局指标

主要结局

Change in the gait parameter (stride length) (This parameter indicated the change of gait performance).

时间窗: Data will be collected at baseline, 4 weeks after intervention commencement, and 4 weeks later, as follow up, after finishing the treatment program.

An electronic walkway that connected to a portable computer will be used to measure the following gait parameter: stride length (m).

The change in the six-minute walk test score ((This parameter indicated the change of walking tolerance abilities).

时间窗: Data will be collected at baseline, 4 weeks after intervention commencement, and 4 weeks later, as follow up, after finishing the treatment program.

The six-minute walk test (6MWT) will assess the distance that the participant's ability to walk for a total of six minutes on a hard, uneven surface. It is has been used to determine exercise tolerance changes following interventions for healthy older adults.

Change in the gait parameter (stride time) (This parameter indicated the change of gait performance).

时间窗: Data will be collected at baseline, 4 weeks after intervention commencement, and 4 weeks later, as follow up, after finishing the treatment program.

An electronic walkway that connected to a portable computer will be used to measure the following gait parameter: stride time (second).

Change in the gait parameter (cadence) (This parameter indicated the change of gait performance).

时间窗: Data will be collected at baseline, 4 weeks after intervention commencement, and 4 weeks later, as follow up, after finishing the treatment program.

An electronic walkway that connected to a portable computer will be used to measure the following gait parameter: cadence (steps/ minute).

Change in the gait parameter (velocity) (This parameter indicated the change of gait performance).

时间窗: Data will be collected at baseline, 4 weeks after intervention commencement, and 4 weeks later, as follow up, after finishing the treatment program.

An electronic walkway that connected to a portable computer will be used to measure the following gait parameter: velocity (meter / second).

次要结局

  • 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)(Data will be collected at baseline, 4 weeks after intervention commencement, and 4 weeks later, as follow up, after finishing the treatment program.)

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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