Virtual Reality Training for Walking Improvement in the Elderly

NCT05623462 | Completed

• 1 other identifier: 22UQU428521DSR01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Gait, Unsteady

Keywords

Gait; Older Adults; Virtual Reality

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 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)

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

Study Arms (2)

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)

Other: Conventional Physical Therapy Program

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)

Device: The C-Mill virtual reality treadmill

Interventions

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.

Experimental Group

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)

Control Group

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Ehab Mohamed Abd El Kafy

Mecca, Mecca Region, 21955, Saudi Arabia

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ehab M Abd El Kafy, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Therapy

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 21, 2022
• Study Start: November 1, 2022
• Primary Completion: March 15, 2023
• Study Completion: March 30, 2023
• Last Updated: January 14, 2025

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Start Date: Beginning one year following main results publication End Date: Ending two years following main results publication
• Access Criteria: Data can be obtained by the Principal Investigator. Email Address: emkafy@uqu.edu.sa

Locations

SA (1)