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Clinical Trials/NCT06672354
NCT06672354
Recruiting
Not Applicable

Effects of Non-immersive Virtual Reality Training Compared to Otago Exercise Program on Balance and Spatiotemporal Gait Parameters in Elderly Population

Foundation University Islamabad1 site in 1 country40 target enrollmentJune 20, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Elderly
Sponsor
Foundation University Islamabad
Enrollment
40
Locations
1
Primary Endpoint
Balance
Status
Recruiting
Last Updated
last year

Overview

Brief 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.

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: 1. To determine the effects of Non-Immersive VR training and Otago exercise program on spatiotemporal gait parameters in elderly population. 2. To determine the effects of Non-Immersive VR training and Otago exercise program on balance in elderly population. 3. To determine the effects of Non-Immersive VR training and Otago exercise program on lower limb strength of elderly population. 4. To determine the effects of Non-Immersive VR training and Otago exercise program on fear of fall in elderly population. HYPOTHESIS: Alternate Hypothesis: 1. There is statistically significant difference between non-immersive virtual reality training and Otago exercise program on spatiotemporal gait parameters in elderly population. 2. There is statistically significant difference between non-immersive virtual reality training and Otago exercise on balance in elderly population. 3. There is statistically significant difference between non-immersive virtual reality training and Otago exercise on lower limb strength in elderly population. 4. There is statistically significant difference between non-immersive virtual reality training and Otago exercise on fear of fall in elderly population. Null Hypothesis: 1. There is no statistically significant difference between non-immersive virtual reality training and Otago exercise program on spatiotemporal gait parameters in elderly population. 2. There is no statistically significant difference between non-immersive virtual reality training and Otago exercise on balance in elderly population. 3. There is no statistically significant difference between non-immersive virtual reality training and Otago exercise on lower limb strength in elderly population. 4. 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 1. Age 55 years and above 2. Male and female both 3. Able to independently ambulate, without the assistance of a walking aid. 4. Participants that are able to maintain upright position with eyes open and eyes close for 10 seconds in standing position Exclusion Criteria 1. Wheel-chair bound elderly 2. Diagnosed with neurological disorder 3. Severe cognitive impairment (MMSE scoring of 17 or \<17) 4. Recent orthopedic trauma 5. 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.

Registry
clinicaltrials.gov
Start Date
June 20, 2024
End Date
December 20, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

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

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)

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)

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.

Study Sites (1)

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