Virtual Reality Training for Walking Improvement in the Elderly

NCT ID: NCT05623462

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-03-30

Brief Summary

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.

Detailed Description

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.

Conditions

Gait, Unsteady

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

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)

Group Type: ACTIVE_COMPARATOR

Conventional Physical Therapy Program

Intervention Type: 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)

Experimental Group

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)

Group Type: EXPERIMENTAL

The C-Mill virtual reality treadmill

Intervention Type: 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.

Interventions

The C-Mill virtual reality treadmill

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.

Intervention Type: DEVICE

Conventional Physical Therapy Program

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)

Intervention Type: OTHER

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Umm Al-Qura University

OTHER

Sponsor Role: lead

Responsible Party

Ehab Mohamed Abd El Kafy

Professor of Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ehab M Abd El Kafy, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Therapy- Faculty of Applied Medical Sciences - Umm Al Qura University

Locations

Ehab Mohamed Abd El Kafy

Mecca, Mecca Region, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

22UQU428521DSR01

Identifier Type: -

Identifier Source: org_study_id