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Completed

NCT Number: NCT05623462

Virtual Reality Training for Walking Improvement in the Elderly

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.

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Key information

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ehab Mohamed Abd El Kafy

Mecca, Mecca Region, 21955, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

The C-Mill virtual reality treadmill

Device

The C-Mill treadmill is an innovative device used for the training of impaired gait and balance. The C-Mill is an instrumented treadmill with interactive virtual reality games and applications.The instrument is supplied with a safety frame, body weight support, treadmill force plates, treadmill belt, adjustable handrails, cameras, user operating system, interactive visual screen and augmented reality projection.

Conventional physical therapy program

Other

The Conventional Physical Therapy Program includes the following:

  • Indoor open environment gait training exercises (over-ground gait training exercises.). (using obstacles, cones, stepper, balance board , and uneven surfaces) (either between or outside the parallel bar)

Primary outcomes

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

    Time frame: 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).

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

    Time frame: 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).

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

    Time frame: 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).

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

    Time frame: 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).

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

    Time frame: 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.

Secondary outcomes

  1. 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)

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

    The Biodex Balance System will be used to assess the Change in the Overall Stability Indices of the Postural Stability Test. The test includes measurement of the following indices: overall stability index, anteroposterior index and mediolateral index which represents the children's ability to control their postural balance stability in all directions. High values % represent less stability and the children had difficulty in balance control. On the other hand lower values were indicative of a better balance control.

Sponsors and collaborators

Lead sponsor

Umm Al-Qura University

Other

Registry information

Official study title

Virtual Reality Treadmill Training for Improving Gait Performance in the Elderly

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 21, 2022
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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