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

NCT ID: NCT06672354

Last Updated: 2024-11-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-20
• Study Completion Date: 2024-12-20

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.

Conditions

Elderly; Balance; Gait; Virtual Reality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Otago Exercise Program Group

It includes participants receiving Otago Exercise Program, which consists of stengthening, balance exercises and walking plan.

Group Type: EXPERIMENTAL

Otago Exercise Program

Intervention Type: PROCEDURE

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 Group

This group involves participants receiving VR training exercises by using Xbox Kinect 360.

Group Type: EXPERIMENTAL

Non-Immersive Virtual Reality Training

Intervention Type: PROCEDURE

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.

Interventions

Otago Exercise Program

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

Intervention Type: PROCEDURE

Non-Immersive Virtual Reality Training

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Foundation University Islamabad

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Foundation University College of Physical Thrapy

Islamabad, , Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

HAFSAH EHSAN, DPT

Role: CONTACT

hafsah.ehsan98@gmail.com

+923129671303

Facility Contacts

Muhammad Ehab Azim, MS-NMPT

Role: primary

ehab@fui.edu.pk

+92515788171 ext. 637

Other Identifiers

FUI/CTR/2024/41

Identifier Type: -

Identifier Source: org_study_id