The aim of this study was to reduce back pain through virtual reality training to help older people to improve motor function and quality of life and reduce their falls.
Design
Double-blind randomized clinical trial with control group (n=27).
Settings and conduct
The present quasi-experimental study is performed in the rehabilitation laboratory of Bu Ali Sina University. The experimental group performs virtual reality exercises for 8 weeks, 3 sessions per week for 30 minutes using a headset (Xbox Kinect). Pain intensity and quality of life index are measured using the Visual Pain Scale (VAS) and SF-36 questionnaire, respectively. The risk of falls is assessed using a Biodex balance system and the foot pressure variables are assessed by a plantar pressure. The muscular strength is measured using dynamometer. Participants and evaluators do not know how to allocate and group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: experience of low back pain in the last six months, age range 60-80 years, no history of spine surgery and hip replacement. Exclusion criteria: history of cardio-respiratory disorders in the last two years, visual impairment, severe musculoskeletal disorders such as severe osteoarthritis.
Intervention groups
Intervention group: The participants in the intervention group perform virtual reality exercises with xbox kinect headset for eight weeks, three sessions per week, and 30 minutes per session. Control group: They will have the usual routine of their lives.
Main outcome variables
Pain; Quality of life index; Risk of falls; Foot pressure variables; Muscular strength
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200204046368N7
Registration date:2021-09-23, 1400/07/01
Registration timing:registered_while_recruiting
Last update:2021-09-23, 1400/07/01
Update count:0
Registration date
2021-09-23, 1400/07/01
Registrant information
Name
Zahra Raeisi
Name of organization / entity
Arak University
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3492
Email address
z_raisi13@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-22, 1400/06/31
Expected recruitment end date
2021-09-27, 1400/07/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual reality training in older people with chronic low back pain
Public title
Virtual reality exercises and aging
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 60 to 80 years
No neurological disorders such as Alzheimer's, MS, Parkinson's
No musculoskeletal disorders such as rheumatoid arthritis and muscular dystrophy
Exclusion criteria:
History of spine or hip surgery
Use muscle relaxants 30 days before the study
Visual impairment
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
27
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization method is parallel. The randomization unit is individual.
The Randlist software is used to randomly assign subjects to study groups. At , the number of subjects and groups is given to the software.
Then, with this software, each subject is assigned a code. A group is then randomly assigned to each code by the software.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher that do laboratory tests were not aware of the allocation of study groups.
The data analyzer will not be aware of the groups classification. The information of the groups will be provided to the data analyzer in the form of numbers 1, 2, 3 and for each participant with a code.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bu Ali Sina university ethics committee in research
Street address
Shahid Mostafa Ahmadi Roshan Street
City
Hamedan
Province
Hamadan
Postal code
6517838695
Approval date
2021-02-28, 1399/12/10
Ethics committee reference number
IR.BASU.REC.1399.035
Health conditions studied
1
Description of health condition studied
Low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Pain
Timepoint
Before and after the intervention
Method of measurement
Visual analogue scale
2
Description
Quality of life index
Timepoint
Before and after the intervention
Method of measurement
SF-36 Questionnaire
3
Description
Risk of falls
Timepoint
Before and after intervention
Method of measurement
Biodex balance system
4
Description
Plantar pressure variables
Timepoint
Before and after the intervention
Method of measurement
Zebris plantar pressure system
5
Description
Muscle Strength
Timepoint
Before and after fatigue
Method of measurement
Dynamometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group performs virtual reality exercises for 8 weeks, 3 sessions per week for 30 minutes using a headset (Xbox Kinect).
Category
Rehabilitation
2
Description
Control group: The control group performs their normal activities for 8 weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu-ali Sina university
Full name of responsible person
Ali Yalfani
Street address
Bu-Ali Sina University, Shahid Mostafa Ahmadi Roshan Street
City
Hamedan
Province
Hamadan
Postal code
6517833131
Phone
+98 81 3838 1422
Email
Ali_yalfani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bu Ali-Sina University
Full name of responsible person
Gholamhossein Majzoubi
Street address
Vice Chancellery For Research Affairs, Bu Ali Sina University, Chahar Bagh Martyr Mustafa Ahmadi Roshan
City
Hamedan
Province
Hamadan
Postal code
6517833131
Phone
+98 81 3838 1601
Email
sakhai@basu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bu Ali-Sina University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Arak University, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Fax
Email
Z_raisi13@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bu Ali-Sina University
Full name of responsible person
Ali Yalfani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Rehabilitation management
Street address
Bu Ali Sina University, Chahar Bagh of martyr Mustafa Ahmadi Roshan
City
Hamedan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1422
Email
ali_yalfani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University
Full name of responsible person
Zahra Raeisi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Arak University, Basij Square
City
Arak
Province
Markazi
Postal code
3848177584
Phone
+98 86 3417 3492
Fax
Email
Z_raisi13@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be 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