Clinical trial NCT06672354: Effects of Non-immersive Virtual Reality Training Compared to Otago Exercise Program on Balance and Spatiotemporal Gait Parameters in Elderly Population
Official title: Effects of Non-immersive Virtual Reality Training Compared to Otago Exercise Program on Balance and Spatiotemporal Gait Parameters in Elderly Population
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Elderly
Balance
Gait
Virtual Reality
Keywords: Elderly
Balance
Gait
Virtual Reality
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Balance
timeFrame: 12 weeks
measure: Gait Speed
timeFrame: 12 weeks
measure: Cycle Time
timeFrame: 12 weeks
measure: Stride Length
timeFrame: 12 weeks
measure: Cadence
timeFrame: 12 weeks
measure: Leg Strength
timeFrame: 12 weeks
measure: Fear of Fall
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University College of Physical Thrapy
Study officials:
References: