Protocol summary

Study aim
Studying the effect of exercise therapy based on virtual reality on photogrammetric data, pain, disability, neck range of motion and balance in young subjects with forward head posture.
Design
Randomized controlled trial with control group, with parallel groups, one blind, randomized by coin toss, on 50 patients.
Settings and conduct
In this study, 50 male and female students from the Faculty of Rehabilitation who live in dormitories affiliated to Shahid Beheshti University of Medical Sciences and refer to the physiotherapy clinic of the Faculty of Rehabilitation of Shahid Beheshti University of Medical Sciences will participate. Then, after a brief explanation about the study, people are randomly divided into two virtual reality groups (25 people) and a control group (25 people).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18-29 years Craniovertebral angle less than 48 degrees Absence of neck pain due to a specific cause such as trauma, whiplash injury, malignant problems. Absence of forward head posture related to structural disorders of osteoporosis or pregnancy. No history of radiculopathy and myopathy diagnosis. No history of inflammatory diseases, spinal tumor and spinal inflammation No history of surgery and neck and spine fracture. No vision problems. No history of physiotherapy treatment in the last month. Exclusion criteria: Dizziness during virtual reality games. Dropout for any reason.
Intervention groups
People in the virtual reality group practice chin tuck in the form of a game with virtual reality glasses. And in the control group, people are taught the chin tuck exercise and should do it at home.
Main outcome variables
Pain, craniovertebral angle, neck range of motion, static and dynamic balance, neck disability index

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231010059686N1
Registration date: 2023-10-24, 1402/08/02
Registration timing: prospective

Last update: 2023-10-24, 1402/08/02
Update count: 0
Registration date
2023-10-24, 1402/08/02
Registrant information
Name
yasaman makoolati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 919 453 8190
Email address
y.makoolati@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-27, 1402/08/05
Expected recruitment end date
2023-12-20, 1402/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of exercise therapy based on virtual reality on photogrammetric data, pain, disability, neck range of motion and balance in young subjects with forward head posture.
Public title
Studying the effect of exercise therapy based on virtual reality on photogrammetric data, pain, disability, neck range of motion and balance in young subjects with forward head posture.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Craniovertebral angle less than 48 degrees Absence of neck pain with a specific cause such as trauma, whiplash injury, malignant problems Absence of forward head posture related to structural disorders of osteoporosis or pregnancy No history of radiculopathy and myopathy diagnosis. No history of inflammatory diseases, spinal tumor and spinal inflammation No history of surgery and neck and spine fracture Absence of visual problems No history of physiotherapy treatment in the last month
Exclusion criteria:
Dizziness during virtual reality games
Age
From 18 years old to 29 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by simple randomization method and coin toss tool
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding of participants to treatment groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
NO.332, Velayat Town, Shahid Babaei highway
City
Tehran
Province
Tehran
Postal code
1698749511
Approval date
2023-10-01, 1402/07/09
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.331

Health conditions studied

1

Description of health condition studied
Forward head posture
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Craniovertebral angle
Timepoint
Before and after the intervention
Method of measurement
Photogrammetry

Secondary outcomes

1

Description
Pian
Timepoint
Before and after the intervention
Method of measurement
Numerical Rating

2

Description
Static balance
Timepoint
Before and after the intervention
Method of measurement
Unipedal Stance Test

3

Description
Dynamic balance
Timepoint
Before and after the intervention
Method of measurement
Star excursion balance test

4

Description
Neck disability index
Timepoint
Before and after the intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: Virtual reality group
Category
Rehabilitation

2

Description
Control group: Exercise group
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Rehabilitation Faculty
Full name of responsible person
Minu Khalkhali
Street address
Damavand St
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Email
info@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Frnaz Fathollahzadeh
Street address
Damavand St
City
Tehran
Province
Tehran
Postal code
616913111
Phone
+98 21 7756 1721
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Yasaman Makoolati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.332, Velayat minicity, Shahid babaei Blv
City
Tehran
Province
Tehran
Postal code
1698749511
Phone
+98 919 453 8190
Fax
Email
y.makoolati@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Yasaman Makoolati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.332, Velayat minicity, Shahid babaei Blv
City
Tehran
Province
Tehran
Postal code
1698749511
Phone
+98 919 453 8190
Fax
Email
y.makoolati@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Yasaman Makoolati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No.332, Velayat minicity, Shahid babaei Blv
City
Tehran
Province
Tehran
Postal code
1698749511
Phone
+98 919 453 8190
Fax
Email
y.makoolati@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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