Gait Training For Reducing Risk Of Fall in the Elderly

Virtual Reality-Based Gait Training For Reducing Risk Of Fall in the Elderly.

Falling is considered one of the major problems that may affect the elderly, which may lead to bad consequences. Safe walking needs the older adult to anticipate and respond quickly to external demands and sudden environmental changes.Many studies have shown that treadmill training is effective in improving the elderly person's ability to walk and avoid falls. The C-Mill treadmill is an innovative device that recently used for the training of impaired gait and balance.Therefore, this study will aim to evaluate the efficacy of gait training with a virtual reality treadmill on the risk of fall in the elderly.

Study Overview

• Status: Recruiting
• Conditions: Fall
• Intervention / Treatment: Device: The C-Mill virtual reality treadmill; Other: Conventional Physical Therapy Program

Detailed Description

Fall injuries produce serious threats to elderly people. Fall hazards are many, they include physical, psychological, social, and economic consequences. Many studies have shown that walking and balance exercises effectively contribute to enhancing walking performance, improving obstacle avoidance, and reducing the incidence of falls in the elderly. Therefore, the practice of complex and challenging situations of the usual daily walking is very important to prevent falls. Many studies have shown that treadmill training is effective in improving the elderly person's ability to walk and avoid falls. The C-Mill treadmill is recently used for the training of impaired gait and balance. C-Mill applies a virtual reality environment, obstacle avoidance games, and a variety of balance challenges in a safe and controlled environment to increase walking adaptability and improve performance in everyday life.Fall injuries produce serious consequences. The management of these injuries is costly and has a negative impact on healthcare entities. Therefore, prevention programs for preventing and reducing falls among the elderly are very important for reducing these serious consequences. Therefore, this study will compare the efficacy of gait training with a virtual reality treadmill and the conventional physical therapy training program on the risk of fall in the elderly.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Mecca, Saudi Arabia, 21955
    • Recruiting
    • Ehab Mohamed Abd El Kafy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

60 healthy older adults, both sexes, will participate in this study. Their ages will be between 60 to 70 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Participants in the control group will receive conventional functional training (conventional physical therapy program) for one hour as the following.; Part (1) Postural reactions exercises. (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; The Conventional Physical Therapy Program include the following: Postural reactions exercises. (using balance board, balance beam, and manual balance perturbations); 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: 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: Postural reactions exercises. ( 20 minutes); Indoor open environment gait training exercises (over-ground gait training exercises.). (10 minutes)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the score of fall risk test . (test that assess the change in risk of fall)	The Biodex Balance System was used to assess the Change in the Overall Stability Index of the Fall Risk Test. In this study, the dynamic level (11) will be selected for applying the fall risk test. The result for every child will be registered and compared to the normative data stored in the software of the device based on children age range.	[Data will be collected at baseline, and 6 weeks after intervention commencement]
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 Index and the Time of Control of the Limit of Stability Test. This test involves measurement of overall directional control which represented as a percentage value (%). The higher scores will indicate better balance control. The test also include measurement of total time required to complete the test (seconds), improvement in this parameter requires minimizing the time recorded to complete the test.	[Data will be collected at baseline, and 6 weeks after intervention commencement]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Timed Up and Go (TUG) (test that assess the probability for falls among elderly)	The Timed Up and Go Test (TUG) will be used to assess the following parameters in older adults: fall risk, walking ability, balance, and mobility. It is a reliable, valid and sensitive test that is a specific measure of the probability for falls among elderly.	[Data will be collected at baseline, and 6 weeks after intervention commencement]

Collaborators and Investigators

• Sponsor: Umm Al-Qura University
• Investigators: Principal Investigator: Ehab M Abd El Kafy, PhD, Department of Physical Therapy- Faculty of Applied Medical Sciences - Umm Al Qura University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Anticipated): January 15, 2023
• Study Completion (Anticipated): January 30, 2023

Study Registration Dates

• First Submitted: November 5, 2022
• First Submitted That Met QC Criteria: November 5, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 5, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Virtual Reality; Treadmill; Fall Risk; The Elderly
• Other Study ID Numbers: 22UQU4280521DSR01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: - The data available is Case-by-case basis at the discretion of Primary Sponsor
• IPD Sharing Time Frame: Start Date: Beginning one year following main results publication End Date: Ending two years following main results publication
• IPD Sharing Access Criteria: Data can be obtained by the Principal Investigator. Email Address: emkafy@uqu.edu.sa
• IPD Sharing Supporting Information Type: Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No