An interventional study of Otago Exercise Program and Non-Immersive Virtual Reality Training in Elderly, Balance and Gait, sponsored by Foundation University Islamabad. Recruiting at 1 site in Pakistan. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-04.
Sponsored by Foundation University Islamabad · Not applicable, Interventional, and Treatment
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.
OBJECTIVES:
The objectives of this study are:
HYPOTHESIS:
Alternate Hypothesis:
Null Hypothesis:
Research Design: Experimental study. Randomized Control Trial
Clinical setting: Multidisciplinary Lab in FUCP. Study duration: 1 year
Selection Criteria:
Inclusion Criteria
Exclusion Criteria
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.
Foundation University Islamabad is the lead sponsor of 253 studies on the registry; 140 are open to participants now.
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Exclusion Criteria:
It includes participants receiving Otago Exercise Program, which consists of stengthening, balance exercises and walking plan.
Procedure: Otago Exercise Program
This group involves participants receiving VR training exercises by using Xbox Kinect 360.
Procedure: Non-Immersive Virtual Reality Training
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
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.
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.
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
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