FallNCT04994678
EFFECT OF VIRTUAL REALITY BASED EXERCISE REGIME ON POSTURAL STABILITY AND GAIT DYNAMICS
A study testing Virtual Reality Training and Moderate Aerobic Exercise Training in people with Fall, run by Foundation University Islamabad at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Fall
- What is being tested?
- Virtual Reality Training and Moderate Aerobic Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University Institute of Rehabilitation Sciences.
Islamabad, Federal, 46000
Muhammad Ehab Azim, +9233355330080
About this study
Official title: EFFECT OF VIRTUAL REALITY-BASED EXERCISE REGIME ON POSTURAL STABILITY AND GAIT DYNAMICS
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.
Read the 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
- Being tested
- Virtual Reality Training, Moderate Aerobic Exercise Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality TrainingOther
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 TrainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Training Group | Experimental | 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. Receives: Other: Virtual Reality Training |
| Moderate Aerobic Exercise Training Group | Active comparator | 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. Receives: Other: Moderate Aerobic Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural Stability Assessment
Postural stability assessment will be done via use of Biodex balance system SD.
Measured: 6 weeks
Gait Parameters
Spatial and temporal Gait Parameters including step width, step length, stride length, cadence.
Measured: 6 weeks
Secondary outcomes (3)
Mobility
Mobility will be assessed using time up and go test
Measured: 6 weeks
Functional Lower Extremity Strength
Functional Lower Extremity Strength will be assessed using 5 times sit to stand
Measured: 6 weeks
Aerobic capacity
Aerobic capacity will be assessed using 6minute walk test
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start15 Jun 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated to interventional group (virtual Reality Training Group) and Control Group (Aerobic Training Group) for whole duration of study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Ehab Azim, Principal investigator, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04994678
- Sponsor's protocol ID
- FUI/CTR/2021/1
- Status last verified
- Aug 2021
- First submitted
- 3 Aug 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF VIRTUAL REALITY-BASED EXERCISE REGIME ON POSTURAL STABILITY AND GAIT DYNAMICS
- ClinicalTrials.gov ID
- NCT04994678
- Acronym / sponsor ID
- FUI/CTR/2021/1
- Conditions
- Fall
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to interventional group (virtual Reality Training Group) and Control Group (Aerobic Training Group) for whole duration of study.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Training Group | Experimental | Other: Virtual Reality TrainingVR 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. |
| Moderate Aerobic Exercise Training Group | Active comparator | Other: Moderate Aerobic Exercise TrainingModerate 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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality TrainingThe 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. | Other | Virtual Reality Training Group |
| Moderate Aerobic Exercise TrainingModerate 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. | Other | Moderate Aerobic Exercise Training Group |
Primary outcome
Postural Stability Assessment
Time frame: 6 weeks
Postural stability assessment will be done via use of Biodex balance system SD.
Gait Parameters
Time frame: 6 weeks
Spatial and temporal Gait Parameters including step width, step length, stride length, cadence.
3 secondary outcomes
Mobility
Time frame: 6 weeks
Functional Lower Extremity Strength
Time frame: 6 weeks
Aerobic capacity
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Ehab Azim principal investigator
Foundation University Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Training and Moderate Aerobic Exercise Training in people with Fall, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Ehab Azim (+9233355330080, ehab@fui.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural Stability Assessment (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2021.