ElderlyNCT06672354
Effects of Non-immersive Virtual Reality Training Compared to Otago Exercise Program on Balance and Spatiotemporal Gait Parameters in Elderly Population
A study testing Otago Exercise Program and Non-Immersive Virtual Reality Training in people with Elderly and Balance, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Falling is a serious concern for the growing elderly population due to age-related decline in physical function, leading to injuries, loss of independence, and a decline in overall well-being. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- What is being tested?
- Otago Exercise Program and Non-Immersive Virtual Reality Training
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jun 2024to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 55 years and above
- Male and female both
- Able to independently ambulate, without the assistance of a walking aid.
- Participants that are able to maintain upright position with eyes open and eyes close for 10 seconds in standing position
Who cannot join
- Wheel-chair bound elderly
- Diagnosed with neurological disorder
- Severe cognitive impairment (MMSE scoring of 17 or <17)
- Recent orthopedic trauma
- Severe degenerative conditions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Thrapy
Islamabad, 44000
Muhammad Ehab Azim, MS-NMPT, +92515788171 ext. 637, ehab@fui.edu.pk
About this study
Falling is a serious concern for the growing elderly population due to age-related decline in physical function, leading to injuries, loss of independence, and a decline in overall well-being.
The Otago Exercise Program (OEP), for the elderly consists of lower limb strengthening and balance exercises, leading to better strength, balance, and reduced fear of falling.
The interactive and game-like nature of VR training can make it more engaging and motivating for older adults. It can provide challenging and engaging approach to exercise that can help to improve stability, enhance quality of life and reduce the risk of fall.
Read the detailed description
OBJECTIVES:
The objectives of this study are:
- To determine the effects of Non-Immersive VR training and Otago exercise program on spatiotemporal gait parameters in elderly population.
- To determine the effects of Non-Immersive VR training and Otago exercise program on balance in elderly population.
- To determine the effects of Non-Immersive VR training and Otago exercise program on lower limb strength of elderly population.
- To determine the effects of Non-Immersive VR training and Otago exercise program on fear of fall in elderly population.
HYPOTHESIS:
Alternate Hypothesis:
- There is statistically significant difference between non-immersive virtual reality training and Otago exercise program on spatiotemporal gait parameters in elderly population.
- There is statistically significant difference between non-immersive virtual reality training and Otago exercise on balance in elderly population.
- There is statistically significant difference between non-immersive virtual reality training and Otago exercise on lower limb strength in elderly population.
- There is statistically significant difference between non-immersive virtual reality training and Otago exercise on fear of fall in elderly population.
Null Hypothesis:
- There is no statistically significant difference between non-immersive virtual reality training and Otago exercise program on spatiotemporal gait parameters in elderly population.
- There is no statistically significant difference between non-immersive virtual reality training and Otago exercise on balance in elderly population.
- There is no statistically significant difference between non-immersive virtual reality training and Otago exercise on lower limb strength in elderly population.
- There is no statistically significant difference between non-immersive virtual reality training and Otago exercise on fear of fall in elderly population.
Research Design: Experimental study. Randomized Control Trial
Clinical setting: Multidisciplinary Lab in FUCP. Study duration: 1 year
Selection Criteria:
Inclusion Criteria
- Age 55 years and above
- Male and female both
- Able to independently ambulate, without the assistance of a walking aid.
- Participants that are able to maintain upright position with eyes open and eyes close for 10 seconds in standing position
Exclusion Criteria
- Wheel-chair bound elderly
- Diagnosed with neurological disorder
- Severe cognitive impairment (MMSE scoring of 17 or <17)
- Recent orthopedic trauma
- Severe degenerative conditions
Technique: Non probability Purposive Sampling
Outcome Measures:
Data will be collected on Demographics and general information. Data will be collected using Mini-BESTEST scale, 10 Meter walk test, 30 sec sit to stand test, The Fall Efficacy Scale International
Expermental Group (A) =This group will recive Otago Exercise Program training outcomes will be measured at baseline, on 4th, 8th and at 12th week of treatment.
Data analysis techniques:
Experimental Group (B) = This group will receive Non-Immersive Virtual Reality training using Xbox Kinect 360. Their outcomes will be measured at baseline, on 4th, 8th and at 12th week of treatment.
The data will be analyzed through SPSS 21 and Data would be analyzed based on the study design chosen that is random control experimental study within the community.
A printed questionnaire will be provided to the patients after obtaining written consent and providing adequate explanation regarding the study, after which the data will be presented in the form of graphs or tables.
Significance of the study:
While the Otago Exercise Program (OEP) has established itself as a highly effective intervention for improving balance and reducing fall risk in older adults, the emergence of non-immersive Virtual Reality (VR) training introduces a potentially complementary approach.
However, despite both offering multi-component interventions targeting fall risk factors, a lack of conclusive evidence exists regarding their differential impact on balance and gait parameters.
Our study addresses this critical gap in the literature by directly comparing the efficacy of non-immersive VR training against the OEP.
- Conditions
- Elderly, Balance, Gait, Virtual Reality
- Being tested
- Otago Exercise Program, Non-Immersive Virtual Reality Training
- Keywords
- Elderly, Balance, Gait, Virtual Reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago Exercise ProgramProcedure or surgery
1- Otago Exercise Program: i) This exercise program will consist of strengthening, balance exercises and walking plan. The OEP will be performed according to the following: 5 min warm-up, 10 min resistance training and 15 min balance exercises.
ii) The strength training protocol targets, on hip abductors, knee flexors, knee extensors, plantarflexors, and dorsiflexors.All exercises will be performed for 10 repetitions. This protocol recommends strength training 3 days per week.
iii) The balance retraining protocol incorporates various exercises. The exercises progress in difficulty through four levels, with Level 1 being the easiest and Level 4 the most challenging. Balance exercises will progress from holding onto a stable supporting structure such as heavy furniture to perform the exercises independent of the support. The protocol recommends participants to carry out balance exercises 3 days a week.
iv) Participants will be instructed to walk at their usual pace for 30 minutes, twice
Non-Immersive Virtual Reality TrainingProcedure or surgery
In this interventional group, VR training exercises will be performed by using Xbox Kinect, which includes a Kinect sensor.-The monitor or Tv screen will recognize the movements of participants via camera and infra-red motion sensors.-In order to perform simulated exercises in each session, the participant will be positioned at 1.5-2 meter from the monitor or TV screen.-The virtual reality training exercises will include Kinect Adventure games (Rally Ball, 20,000 leaks, Reflex Ridge) and Sports pack 1 games (Super Saver, Target Kick, Body ball).-Exercises will be continued for 30-45 minutes each session, for 3 alternate days per week for a total period of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Otago Exercise Program Group | Experimental | It includes participants receiving Otago Exercise Program, which consists of stengthening, balance exercises and walking plan. Receives: Procedure: Otago Exercise Program |
| Non-Immersive Virtual Reality Group | Experimental | This group involves participants receiving VR training exercises by using Xbox Kinect 360. Receives: Procedure: Non-Immersive Virtual Reality Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
The Mini-BESTest includes 14 items that examine performance tasks related to dynamic balance. The test has a maximum score of 28 points from 14 items that are each scored from 0-2.
Measured: 12 weeks
Gait Speed
he 10 Meter Walk Test, will be used to assess walking speed in meters per second over a short distance. Using the data from the test i.e. time taken to complete distance and step count, gait speed will be evaluated based on the given formula: Distance walked/time(sec)
Measured: 12 weeks
Cycle Time
The 10 Meter Walk Test, will be used to assess walking speed in meters per second over a short distance. Using the data from the test i.e. time taken to complete distance and step count, cycle time will be evaluated based on the given formula: Time(sec) x 2 /No. of steps
Measured: 12 weeks
Stride Length
The 10 Meter Walk Test, a performance measure will be used to assess walking speed in meters per second over a short distance. Using the data from the test i.e. time taken to complete distance and step count, stride length will be evaluated based on the given formula: gait speed (m/s) x cycle time(sec)
Measured: 12 weeks
Cadence
The 10 Meter Walk Test, a performance measure will be used to assess walking speed in meters per second over a short distance. Using the data from the test i.e. time taken to complete distance and step count, cadence will be evaluated based on the given formula: No of steps x 60/time(sec)
Measured: 12 weeks
Leg Strength
The 30 Second Sit to Stand Test will be used to test leg strength and endurance in older adults. The test stand involves recording the number of stands a person can complete in 30 seconds.
Measured: 12 weeks
Fear of Fall
The Falls Efficacy Scale International, measure of "fear of falling" or "concerns about falling. It is a 16-item questionnaire, the item scores are summed up to obtain a total, with a score ranging from minimum 16 to maximum 64.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start20 Jun 2024
- Primary completion15 Nov 2024 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06672354
- Sponsor's protocol ID
- FUI/CTR/2024/41
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Non-immersive Virtual Reality Training Compared to Otago Exercise Program on Balance and Spatiotemporal Gait Parameters in Elderly Population
- ClinicalTrials.gov ID
- NCT06672354
- Acronym / sponsor ID
- FUI/CTR/2024/41
- Conditions
- Elderly, Balance, Gait, Virtual Reality
- Keywords
- Elderly, Balance, Gait, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 4 Nov 2024 (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.
Falling is a serious concern for the growing elderly population due to age-related decline in physical function, leading to injuries, loss of independence, and a decline in overall well-being.
The Otago Exercise Program (OEP), for the elderly consists of lower limb strengthening and balance exercises, leading to better strength, balance, and reduced fear of falling.
The interactive and game-like nature of VR training can make it more engaging and motivating for older adults. It can provide challenging and engaging approach to exercise that can help to improve stability, enhance quality of life and reduce the risk of fall.
Detailed description
OBJECTIVES:
The objectives of this study are:
- To determine the effects of Non-Immersive VR training and Otago exercise program on spatiotemporal gait parameters in elderly population.
- To determine the effects of Non-Immersive VR training and Otago exercise program on balance in elderly population.
- To determine the effects of Non-Immersive VR training and Otago exercise program on lower limb strength of elderly population.
- To determine the effects of Non-Immersive VR training and Otago exercise program on fear of fall in elderly population.
HYPOTHESIS:
Alternate Hypothesis:
- There is statistically significant difference between non-immersive virtual reality training and Otago exercise program on spatiotemporal gait parameters in elderly population.
- There is statistically significant difference between non-immersive virtual reality training and Otago exercise on balance in elderly population.
- There is statistically significant difference between non-immersive virtual reality training and Otago exercise on lower limb strength in elderly population.
- There is statistically significant difference between non-immersive virtual reality training and Otago exercise on fear of fall in elderly population.
Null Hypothesis:
- There is no statistically significant difference between non-immersive virtual reality training and Otago exercise program on spatiotemporal gait parameters in elderly population.
- There is no statistically significant difference between non-immersive virtual reality training and Otago exercise on balance in elderly population.
- There is no statistically significant difference between non-immersive virtual reality training and Otago exercise on lower limb strength in elderly population.
- There is no statistically significant difference between non-immersive virtual reality training and Otago exercise on fear of fall in elderly population.
Research Design: Experimental study. Randomized Control Trial
Clinical setting: Multidisciplinary Lab in FUCP. Study duration: 1 year
Selection Criteria:
Inclusion Criteria
- Age 55 years and above
- Male and female both
- Able to independently ambulate, without the assistance of a walking aid.
- Participants that are able to maintain upright position with eyes open and eyes close for 10 seconds in standing position
Exclusion Criteria
- Wheel-chair bound elderly
- Diagnosed with neurological disorder
- Severe cognitive impairment (MMSE scoring of 17 or <17)
- Recent orthopedic trauma
- Severe degenerative conditions
Technique: Non probability Purposive Sampling
Outcome Measures:
Data will be collected on Demographics and general information. Data will be collected using Mini-BESTEST scale, 10 Meter walk test, 30 sec sit to stand test, The Fall Efficacy Scale International
Expermental Group (A) =This group will recive Otago Exercise Program training outcomes will be measured at baseline, on 4th, 8th and at 12th week of treatment.
Data analysis techniques:
Experimental Group (B) = This group will receive Non-Immersive Virtual Reality training using Xbox Kinect 360. Their outcomes will be measured at baseline, on 4th, 8th and at 12th week of treatment.
The data will be analyzed through SPSS 21 and Data would be analyzed based on the study design chosen that is random control experimental study within the community.
A printed questionnaire will be provided to the patients after obtaining written consent and providing adequate explanation regarding the study, after which the data will be presented in the form of graphs or tables.
Significance of the study:
While the Otago Exercise Program (OEP) has established itself as a highly effective intervention for improving balance and reducing fall risk in older adults, the emergence of non-immersive Virtual Reality (VR) training introduces a potentially complementary approach.
However, despite both offering multi-component interventions targeting fall risk factors, a lack of conclusive evidence exists regarding their differential impact on balance and gait parameters.
Our study addresses this critical gap in the literature by directly comparing the efficacy of non-immersive VR training against the OEP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Otago Exercise Program Group | Experimental | Procedure: Otago Exercise ProgramIt includes participants receiving Otago Exercise Program, which consists of stengthening, balance exercises and walking plan. |
| Non-Immersive Virtual Reality Group | Experimental | Procedure: Non-Immersive Virtual Reality TrainingThis group involves participants receiving VR training exercises by using Xbox Kinect 360. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 55 years and above
- Male and female both
- Able to independently ambulate, without the assistance of a walking aid.
- Participants that are able to maintain upright position with eyes open and eyes close for 10 seconds in standing position
Key exclusion criteria (5 listed)
- Wheel-chair bound elderly
- Diagnosed with neurological disorder
- Severe cognitive impairment (MMSE scoring of 17 or <17)
- Recent orthopedic trauma
- Severe degenerative conditions
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 |
|---|---|---|
| Otago Exercise Program1- Otago Exercise Program: i) This exercise program will consist of strengthening, balance exercises and walking plan. The OEP will be performed according to the following: 5 min warm-up, 10 min resistance training and 15 min balance exercises. ii) The strength training protocol targets, on hip abductors, knee flexors, knee extensors, plantarflexors, and dorsiflexors.All exercises will be performed for 10 repetitions. This protocol recommends strength training 3 days per week. iii) The balance retraining protocol incorporates various exercises. The exercises progress in difficulty through four levels, with Level 1 being the easiest and Level 4 the most challenging. Balance exercises will progress from holding onto a stable supporting structure such as heavy furniture to perform the exercises independent of the support. The protocol recommends participants to carry out balance exercises 3 days a week. iv) Participants will be instructed to walk at their usual pace for 30 minutes, twice | Procedure or surgery | Otago Exercise Program Group |
| Non-Immersive Virtual Reality TrainingIn this interventional group, VR training exercises will be performed by using Xbox Kinect, which includes a Kinect sensor.-The monitor or Tv screen will recognize the movements of participants via camera and infra-red motion sensors.-In order to perform simulated exercises in each session, the participant will be positioned at 1.5-2 meter from the monitor or TV screen.-The virtual reality training exercises will include Kinect Adventure games (Rally Ball, 20,000 leaks, Reflex Ridge) and Sports pack 1 games (Super Saver, Target Kick, Body ball).-Exercises will be continued for 30-45 minutes each session, for 3 alternate days per week for a total period of 12 weeks. | Procedure or surgery | Non-Immersive Virtual Reality Group |
Primary outcome
Balance
Time frame: 12 weeks
The Mini-BESTest includes 14 items that examine performance tasks related to dynamic balance. The test has a maximum score of 28 points from 14 items that are each scored from 0-2.
Gait Speed
Time frame: 12 weeks
he 10 Meter Walk Test, will be used to assess walking speed in meters per second over a short distance. Using the data from the test i.e. time taken to complete distance and step count, gait speed will be evaluated based on the given formula: Distance walked/time(sec)
Cycle Time
Time frame: 12 weeks
The 10 Meter Walk Test, will be used to assess walking speed in meters per second over a short distance. Using the data from the test i.e. time taken to complete distance and step count, cycle time will be evaluated based on the given formula: Time(sec) x 2 /No. of steps
Stride Length
Time frame: 12 weeks
The 10 Meter Walk Test, a performance measure will be used to assess walking speed in meters per second over a short distance. Using the data from the test i.e. time taken to complete distance and step count, stride length will be evaluated based on the given formula: gait speed (m/s) x cycle time(sec)
Cadence
Time frame: 12 weeks
The 10 Meter Walk Test, a performance measure will be used to assess walking speed in meters per second over a short distance. Using the data from the test i.e. time taken to complete distance and step count, cadence will be evaluated based on the given formula: No of steps x 60/time(sec)
Leg Strength
Time frame: 12 weeks
The 30 Second Sit to Stand Test will be used to test leg strength and endurance in older adults. The test stand involves recording the number of stands a person can complete in 30 seconds.
Fear of Fall
Time frame: 12 weeks
The Falls Efficacy Scale International, measure of "fear of falling" or "concerns about falling. It is a 16-item questionnaire, the item scores are summed up to obtain a total, with a score ranging from minimum 16 to maximum 64.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otago Exercise Program and Non-Immersive Virtual Reality Training in people with Elderly and Balance, 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 4 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HAFSAH EHSAN, DPT (+923129671303, hafsah.ehsan98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: 12 weeks). The study lists 7 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 4 Nov 2024; AzTrials last refreshed its copy on 26 Oct 2026.