EFFECT OF VIRTUAL REALITY BASED EXERCISE REGIME ON POSTURAL STABILITY AND GAIT DYNAMICS

NCT ID: NCT04994678

Last Updated: 2021-08-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2022-09-30

Brief Summary

People worldwide are living longer. Today, for the first time in history, most people can expect to live into their sixties and beyond. By 2050, the world's population aged 60 years and older is expected to total 2 billion, up from 900 million in 2015. Today, 125 million people are aged 80 years or older. By 2050, there will be almost this many (120 million) living in China alone, and 434 million people in this age group worldwide. By 2050, 80% of all older people will live in low- and middle-income countries.

As we age, we lose balance function through loss of sensory elements, the ability to integrate information and issue motor commands, and because we lose musculoskeletal function. Diseases common in aging populations lead to further deterioration in balance function in some patients.

study aims to determine the Effect of Virtual Reality exercise regimen on postural stability and gait dynamics in elderly population. By obtaining these results we can recommend and effective balance training regime which can be implemented in health care system and hence resulting in decrease fall events in geriatric population and also reduce fall related health care financial burden on economy.

Detailed Description

Elderly population presenting in Emergency Room are responsible for increased consumption of health care resources but they are easily identifiable population who have high risk of fall. Older people have the highest risk of death or serious injury arising from a fall and the risk increases with age. For example, in the United States of America, 20-30% of older people who fall suffer moderate to severe injuries such as bruises, hip fractures, or head trauma. This risk level may be in part due to physical, sensory, and cognitive changes associated with ageing, in combination with environments that are not adapted for an ageing population.

Falls and falls risks can be reduced through systematic risk identification and targeted intervention, including a combination of clinical and community-based interventions. Multiple evidence-based community programs have been shown to reduce falls and/or falls risk factors.

Using the gaming with the biofeedback system, such as the virtual reality (VR) system, is widely used for rehabilitation. It is due to the fact that the VR system can make the treatment more interesting, reduce the difficulty of rehabilitation, and increase safety In this study participants will be divided in 2 groups.

1 group will recieve Virtual reality Training and other group will Recieve Aerobic Training.

Treatment will be given 3 times a week for 6 weeks by researcher with each session lasting 30-50 Minutes.

Assessment of postural stability and other outcome measures will be done after every two weeks till Terminal assessment after 6 weeks of treatment by same Physical Therapist who did initial Assessment. In addition, assessment gait parameters will be done at baseline and at end of trial.

Conditions

Fall

Study Design

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

Study Groups

Virtual Reality Training Group

VR training system will be setup in multidisciplinary lab of Foundation University Institute of Rehabilitation Sciences Foundation University Islamabad. Display will be provided on 55 inch LED TV with audio feedback. Display will be at height of 5 feet from floor and at distance of 6 feet from Subject. The Virtual reality based training group will receive a game based virtual reality training via XBOX 360 or wii fit balance games. Particiapants will be required to physically move to move avatar on screen to rapidly leaning away, squat to avoid overhead obstacles and try small jump to avoid lower obstacles, single leg stance, in addition person will required to do half squatting, side to side jumps and vertical jumps. Treatment will be provided 3 times a week for 6 weeks with each session lasting for 30-50 minutes. Progressively challenge will be increased.

Group Type: EXPERIMENTAL

Virtual Reality Training

Intervention Type: OTHER

The Virtual reality based training group will receive a game based virtual reality training via XBOX 360or wii fit balance games. Player will be required to rapidly leaning away, squat to avoid overhead obstacles and try small jump to avoid lower obstacles, single leg stance, in addition person will required to do half squatting, side to side jumps and vertical jumps. Treatment will be provided 3 times a week or 6 weeks with each session lasting for 30-50 minutes. Progressively challenge will be increased.

Moderate Aerobic Exercise Training Group

Moderate aerobic exercise training will be provided using motorized tread mill and stationary/recombinent cycle. Treatment will be provided for 30-50 minutes 3 times a week for 6 weeks.

Group Type: ACTIVE_COMPARATOR

Moderate Aerobic Exercise Training

Intervention Type: OTHER

Moderate intensity continuous Aerobic exercises (Recombinant/Stationary cycling for 10-15 min with progression followed by treadmill walking for 10-15 min with progression, as well as stepping and Jogging). The session will be preceded by 5-7 minute warm-up \& 7-10 min cool-down.

Interventions

Virtual Reality Training

The Virtual reality based training group will receive a game based virtual reality training via XBOX 360or wii fit balance games. Player will be required to rapidly leaning away, squat to avoid overhead obstacles and try small jump to avoid lower obstacles, single leg stance, in addition person will required to do half squatting, side to side jumps and vertical jumps. Treatment will be provided 3 times a week or 6 weeks with each session lasting for 30-50 minutes. Progressively challenge will be increased.

Intervention Type: OTHER

Moderate Aerobic Exercise Training

Moderate intensity continuous Aerobic exercises (Recombinant/Stationary cycling for 10-15 min with progression followed by treadmill walking for 10-15 min with progression, as well as stepping and Jogging). The session will be preceded by 5-7 minute warm-up \& 7-10 min cool-down.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Elderly Population the age of 55 Years
• Either Gender

Exclusion Criteria

• Severe orthopedic, cardiovascular pulmonary disease.
• History of Surgery & Severe Trauma of Lower extremity.
• Other musculoskeletal Disorders (Scoliosis & Lordosis)

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Foundation University Islamabad

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhammad Ehab Azim

Role: PRINCIPAL_INVESTIGATOR

Foundation University Islamabad

Locations

Foundation University Institute of Rehabilitation Sciences.

Islamabad, Federal, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Muhammad Ehab Azim

Role: CONTACT

ehab@fui.edu.pk

+9233355330080

Facility Contacts

Muhammad Ehab Azim

Role: primary

+9233355330080

Other Identifiers

FUI/CTR/2021/1

Identifier Type: -

Identifier Source: org_study_id