To compare effects of virtual reality and routine physical therapy on balance and postural control in adulthood population having risk of fall
Design
Randomized clinical Trial. single-blinded, 64 samples, parallel groups, randomized by computer-generated method and further concealed envelop method used for allocation in the group. In the envelope, 1 will be code for the control group and 2 will be code for the experimental group.
Settings and conduct
The study will be conducted at the Department of Physiotherapy Al-Noor Hospital Pasrur, Sialkot with the approval of UIPT UOL. The study will be single-blinded.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
• Age 40-65 years.
• Both gender
• Capable of walking with and without any assistance
• Having normal and corrected visual and auditory acuity
• Having Berg Balance Scale Score from 21-40.
• Can understand instructions.
• Individuals with disease, diabetes mellitus, knee osteoarthritis grade 1 on Kellgren
and Lawrence scale will also be included.
Exclusion Criteria:
• Any comorbidity.
• A history of other neurological, cardiovascular, or orthopedic diseases affecting postural stability
• All patients having a pacemaker or a history of serious cardiac event or of cardiorespiratory dysfunction
• Severe cognitive impairment or aphasia leading to difficulty in communication
Intervention groups
INTERVENTION GROUP (Virtual Reality Exercise)
The intervention group will be receiving simulated balance exercises in the form of 30–60-min sessions on a weekly basis (5 days) for 6 weeks. For simulated balance exercises, Xbox Kinect will be applied, which is a game console simulating balance exercise in the game environment and allows a person to move freely and have diverse positions.
Main outcome variables
Balance and Postural control.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210321050752N4
Registration date:2023-09-09, 1402/06/18
Registration timing:registered_while_recruiting
Last update:2023-09-09, 1402/06/18
Update count:0
Registration date
2023-09-09, 1402/06/18
Registrant information
Name
Muhammad Waqas
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 42 36532841
Email address
drwaqasfayyaz@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-19, 1402/03/29
Expected recruitment end date
2023-12-19, 1402/09/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of virtual reality and routine physical therapy on balance and postural control in adulthood population with risk of fall
Public title
Effects of virtual reality and routine physical therapy on balance and postural control
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40-65 years
Both gender
Capable of walking with and without any assistance
Having normal and corrected visual and auditory acuity
Having Berg Balance Scale Score from 21-40
Can understand instructions
Individuals with disease, diabetes mellitus, knee osteoarthritis grade 1 on Kellgrenand Lawrence scale will also be included.
Patients with no cognitive impairments will be considered (assessed on MDS cognitive performance scale)
Exclusion criteria:
Any comorbidity such as malignancy, inflammatory rheumatologic disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, lupus erythematosus etc.
A history of other neurological, cardiovascular, or orthopedic diseases affecting postural stability
All patients having a pacemaker or a history of serious cardiac event or of cardiorespiratory dysfunction
Severe cognitive impairment or aphasia leading to difficulty in communication
Participants are unwilling to comply with the protocol.
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The lottery method will be used for randomization by using random number-generating software and further concealed envelop method is used for allocation in the group. In the envelop, 1 will be code for the control group and 2 will be code for the experimental group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Assessor will only assess the patient at baseline and after follow-up for treatment outcomes. Assessor safe the data for follow-up and will not share it with any therapist or patient. At any stage, the assessor is unaware of the treatment and control group. The study was single-blinded. The assessor was unaware of the treatment given to either groups 1 or 2.
Other and unspecified abnormalities of gait and mobility
2
Description of health condition studied
Postural control
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Balance
Timepoint
Data will be collected at baseline, at the end of 6th week and after 8th week.
Method of measurement
Berg balance scale will be used to assess balance.
2
Description
Postural control
Timepoint
Data will be collected at baseline, at the end of 6th week and after 8th week.
Method of measurement
Mini-Balance Evaluation Systems Test (Mini-BESTest) will be used to assess the postural control.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will be receiving simulated balance exercises in the form of 30–60-min sessions on a weekly basis (5 days) for 6 weeks. For simulated balance exercises, Xbox Kinect will be applied.
Category
Rehabilitation
2
Description
Control group: The control group will receive routine physical therapy five days week for a 6-weeks. The routine physical therapy will include range of motion (upper and lower limbs- 5 reps of each movement), stretching (for trunk and lower extremity muscles with 3 repetitions of 40 seconds sustained stretch) and strengthening exercises
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Physiotherapy, Al-Noor Hospital Pasrur, Sialkot
Full name of responsible person
Dr. Ejaz Aslam
Street address
Kalaswala Rd Near Lrbt Hospital, Sialkot Road
City
Sialkot
Postal code
51480
Phone
+92 345 2133130
Email
alnoorhospitalpsr@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Self Supported
Full name of responsible person
Samreen Fatima
Street address
St# 76, H#09 Muhala Sirajpura Darogawala Shalamar Town Lahore
City
Lahore
Postal code
1234
Phone
+92 332 0933109
Email
samreen.rehman975@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Self Supported
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Muhammad Waqas
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
St# 76, H#09 Muhala Sirajpura Darogawala Shalamar Town Lahore
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Mini-Balance Evaluation Systems Test (Mini-BESTest) will be used to assess the postural control.
When the data will become available and for how long
6 months after publication.
To whom data/document is available
academic and clinical research writers.
Under which criteria data/document could be used
Never without permission.
From where data/document is obtainable
From Muhammad Waqas through mail id. drwaqasfayyaz@gmail.com or through a Researchgate account. https://www.researchgate.net/profile/Muhammad-Waqas-26?ev=hdr_xprf
What processes are involved for a request to access data/document
From Muhammad Waqas through mail id. drwaqasfayyaz@gmail.com or through a Researchgate account. https://www.researchgate.net/profile/Muhammad-Waqas-26?ev=hdr_xprf