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Virtual Reality Training for Walking Improvement in the Elderly

Primary Purpose

Gait, Unsteady

Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
The C-Mill virtual reality treadmill
Conventional Physical Therapy Program
Sponsored by
Umm Al-Qura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gait, Unsteady focused on measuring Gait, Older Adults, Virtual Reality

Eligibility Criteria

65 Years - 75 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ehab Mohamed Abd El KafyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Experimental Group

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 11, 2022
Last Updated
February 2, 2023
Sponsor
Umm Al-Qura University
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1. Study Identification

Unique Protocol Identification Number
NCT05623462
Brief Title
Virtual Reality Training for Walking Improvement in the Elderly
Official Title
Virtual Reality Treadmill Training for Improving Gait Performance in the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umm Al-Qura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait, Unsteady
Keywords
Gait, Older Adults, Virtual Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
The C-Mill virtual reality treadmill
Intervention Description
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
Other
Intervention Name(s)
Conventional Physical Therapy Program
Intervention Description
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 Outcome Measure Information:
Title
Change in the gait parameter (stride length) (This parameter indicated the change of gait performance).
Description
An electronic walkway that connected to a portable computer will be used to measure the following gait parameter: stride length (m).
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.
Title
Change in the gait parameter (stride time) (This parameter indicated the change of gait performance).
Description
An electronic walkway that connected to a portable computer will be used to measure the following gait parameter: stride time (second).
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.
Title
Change in the gait parameter (cadence) (This parameter indicated the change of gait performance).
Description
An electronic walkway that connected to a portable computer will be used to measure the following gait parameter: cadence (steps/ minute).
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.
Title
Change in the gait parameter (velocity) (This parameter indicated the change of gait performance).
Description
An electronic walkway that connected to a portable computer will be used to measure the following gait parameter: velocity (meter / second).
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.
Title
The change in the six-minute walk test score ((This parameter indicated the change of walking tolerance abilities).
Description
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.
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.
Secondary Outcome Measure Information:
Title
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)
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ehab M Abd El Kafy, PhD
Phone
+966531698541
Email
emkafy@uqu.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehab M Abd El Kafy, PhD
Organizational Affiliation
Department of Physical Therapy- Faculty of Applied Medical Sciences - Umm Al Qura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ehab Mohamed Abd El Kafy
City
Mecca
ZIP/Postal Code
21955
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ehab M Abd El Kafy
Phone
0531698541
Email
emkafy@uqu.edu.sa

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
- The data available is Case-by-case basis at the discretion of the 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

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Virtual Reality Training for Walking Improvement in the Elderly

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