The effect of virtual reality exercises on the psychological profile of injury (quality of life, fear of re-injury) and motor defects during the performance of motor functional tests in people with ankle injuries
The effect of virtual reality exercises on the psychological profile of injury and motor defects during the performance of motor functional tests in people with ankle injuries
Design
The research will be quasi-experimental with pre-test and post-test design in which the effect of virtual reality training on psychological factors and movement defects of athletes with chronic ankle instability between the two experimental groups (virtual reality training) and the control group (daily activity). With the pre-test and post-test process will be evaluated in two groups.
Settings and conduct
The present study will be performed in one of the physiotherapy centers in Tehran. The method also started by assessing the fear of re-injury and modifying the movement pattern of these people and then after the pre-test stage, people entered the research and training protocol and were divided into control and experimental groups. The experimental group also performed virtual reality exercises according to the protocol for 6 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: men in the age range of 20-30 years with ankle injury, having a score less than 24 in the functional ankle instability questionnaire (CAIT), scoring less than 90% of the functional instability assessment questionnaire FAAM-ADL ankle and 80% in FAAMS sports questionnaire, ability to perform painless training protocol, no neuropathy, no history of diseases such as cardiovascular disease, respiratory problems, severe low back pain in the last 6 months, no emotional problems and stress and Do not use neuroleptics and sedatives.
Intervention groups
Subjects will be divided into two groups of 15 people control and 15 people experimental.
Main outcome variables
Fear of re-injury - correction of movement pattern
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200510047381N2
Registration date:2021-12-17, 1400/09/26
Registration timing:prospective
Last update:2021-12-17, 1400/09/26
Update count:0
Registration date
2021-12-17, 1400/09/26
Registrant information
Name
Mohammad hani Mansori
Name of organization / entity
The University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 25 3662 2375
Email address
haninio74@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-05, 1400/10/15
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual reality exercises on the psychological profile of injury (quality of life, fear of re-injury) and motor defects during the performance of motor functional tests in people with ankle injuries
Public title
The effect of virtual reality exercises on the mental and physical performance of people with ankle injuries
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
* Voluntary participation in research
* Men aged 20-30 years with ankle injuries*
* Having a score less than 24 in the Ankle Functional Instability Questionnaire (CAIT)
* Score less than 90% on the FAAM-ADL Ankle Functional Instability Assessment Questionnaire and 80% on the FAAMS Sports Questionnaire
* Ability to implement painless training protocol
* No neuropathy
* No history of diseases such as cardiovascular disease, respiratory problems, severe low back pain in the last 6 months
* No emotional problems and stress and no use of neuroleptics and sedatives
Exclusion criteria:
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
A simple random allocation method was used for random assignment of subjects to control and experimental groups. In this way, each person was assigned a number from the sealed envelope and the individuals were placed in the experimental group according to the selected number if they were even and in the control group if they were individuals.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2021-12-11, 1400/09/20
Ethics committee reference number
IR.UMSHA.REC.1400.702
Health conditions studied
1
Description of health condition studied
Ankle and foot injuries
ICD-10 code
M25.37
ICD-10 code description
Other instability, ankle and foot
Primary outcomes
1
Description
Assessment of fear of re-injury by Tampa Fear of re-injury questionnaire
Timepoint
Before and after the training protocol
Method of measurement
Tampa Fear of re-injury questionnaire
2
Description
Modification of movement pattern by Efficiency Movement (ME) test
Timepoint
Before and after the training protocol
Method of measurement
Efficiency Movement (ME) test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Virtual reality exercises
Category
Rehabilitation
2
Description
Control group: Does not receive training protocol
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Laboratory of corrective exercises of the Faculty of Physical Education, University of Tehran
Full name of responsible person
Mohammad Hani Mansouri Asl
Street address
Amirabad Street between 15th and 17th Alley
City
Tehran
Province
Tehran
Postal code
3718947474
Phone
+98 25 3662 2375
Email
Haninio74@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Homa Naderi Far
Street address
Hamedan, Shahid Fahmideh St., in front of the People's Park of the Educational Complex of Hamedan University of Medical Sciences and Health Services
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 0924
Email
hnaderifar121@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
50
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
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad hani Mansouri Asl
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
Amirabad Street between 15th and 17th Alley
City
Tehran
Province
Tehran
Postal code
3718947474
Phone
+98 25 3662 2375
Email
Haninio74@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Hani Mansouri Asl
Position
Masters student
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
Amirabad Street between 15th and 17th Alley
City
Tehran
Province
Tehran
Postal code
3718947474
Phone
+98 25 3662 2375
Email
Haninio74@gmil.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Hani Mansouri Asl
Position
کارشناسی ارشد
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
Amirabad Street between 15th and 17th Alley
City
Tehran
Province
Tehran
Postal code
3718947474
Phone
+98 25 3662 2375
Email
Haninio74@gmail.com
Sharing plan
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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data on participants' descriptive information as well as pre-test and post-test research variables can be shared
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
If a researcher intends to compare with her(his) research work
From where data/document is obtainable
researcher-haninio74@gmail.com
What processes are involved for a request to access data/document