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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04994678
Other study ID # FUI/CTR/2021/1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 15, 2021
Est. completion date September 30, 2022

Study information

Verified date August 2021
Source Foundation University Islamabad
Contact Muhammad Ehab Azim
Phone +9233355330080
Email ehab@fui.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 56
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 85 Years
Eligibility Inclusion Criteria - Elderly Population the age of 55 Years - Either Gender - Not performing any Systematic strength or Aerobic Training Exclusion Criteria - Severe orthopedic, cardiovascular pulmonary disease. - History of Surgery & Severe Trauma of Lower extremity. - Other musculoskeletal Disorders (Scoliosis & Lordosis)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.
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.

Locations

Country Name City State
Pakistan Foundation University Institute of Rehabilitation Sciences. Islamabad Federal

Sponsors (1)

Lead Sponsor Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postural Stability Assessment Postural stability assessment will be done via use of Biodex balance system SD. 6 weeks
Primary Gait Parameters Spatial and temporal Gait Parameters including step width, step length, stride length, cadence. 6 weeks
Secondary Mobility Mobility will be assessed using time up and go test 6 weeks
Secondary Functional Lower Extremity Strength Functional Lower Extremity Strength will be assessed using 5 times sit to stand 6 weeks
Secondary Aerobic capacity Aerobic capacity will be assessed using 6minute walk test 6 weeks
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