Virtual Reality Training for Walking Improvement in the Elderly

Gait, Unsteady Clinical Trial

Official title:

Virtual Reality Treadmill Training for Improving Gait Performance in the Elderly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05623462
• Other study ID #: 22UQU428521DSR01
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: November 2022
• Source: Umm Al-Qura University
• Contact: Ehab M Abd El Kafy, PhD
• Phone: +966531698541
• Email: emkafy[@]uqu.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 75 Years

Eligibility

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,

• ?xed 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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Unsteady

Intervention

Device:
• 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.

Other:
• 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)

Locations

Country	Name	City	State
Saudi Arabia	Ehab Mohamed Abd El Kafy	Mecca

Sponsors (1)

Lead Sponsor	Collaborator
Umm Al-Qura University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the gait parameter (stride length) (This parameter indicated the change of gait performance).	An electronic walkway that connected to a portable computer will be used to measure the following gait parameter: stride length (m).	Data will be collected at baseline, 4 weeks after intervention commencement, and 4 weeks later, as follow up, after finishing the treatment program.
Primary	Change in the gait parameter (stride time) (This parameter indicated the change of gait performance).	An electronic walkway that connected to a portable computer will be used to measure the following gait parameter: stride time (second).	Data will be collected at baseline, 4 weeks after intervention commencement, and 4 weeks later, as follow up, after finishing the treatment program.
Primary	Change in the gait parameter (cadence) (This parameter indicated the change of gait performance).	An electronic walkway that connected to a portable computer will be used to measure the following gait parameter: cadence (steps/ minute).	Data will be collected at baseline, 4 weeks after intervention commencement, and 4 weeks later, as follow up, after finishing the treatment program.
Primary	Change in the gait parameter (velocity) (This parameter indicated the change of gait performance).	An electronic walkway that connected to a portable computer will be used to measure the following gait parameter: velocity (meter / second).	Data will be collected at baseline, 4 weeks after intervention commencement, and 4 weeks later, as follow up, after finishing the treatment program.
Primary	The change in the six-minute walk test score ((This parameter indicated the change of walking tolerance abilities).	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.	Data will be collected at baseline, 4 weeks after intervention commencement, and 4 weeks later, as follow up, after finishing the treatment program.
Secondary	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)	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.	Data will be collected at baseline, 4 weeks after intervention commencement, and 4 weeks later, as follow up, after finishing the treatment program.