The purpose of this study is to investigate the effect of eight weeks of corrective exercises on head and shoulder angle, strength and endurance of neck muscles in teenagers who use smart phones.
Design
A clinical trial with two exercise groups of corrective and control movements, with parallel groups, singel blind, randomized on 40 participants. Randomization is done based on the Random Number Generator software and will be assigned to double groups based on the concealment of allocation using the SNOSE method.
Settings and conduct
This study will be done in a single blind manner. The tests will be taken in the sports rehabilitation laboratory of Bu Ali Sina University in Hamedan by experts in this field; Then intervention and exercises will take place in the sports hall of this university.
Participants/Inclusion and exclusion criteria
Entry criteria: female students aged 12-17 who receive or send at least 25 text messages or emails per day; They surf the web and play games on a smart phone for at least one hour a day, and use a smart phone for at least three hours a day; Exclusion criteria: Congenital disorders and insufficiency in the neck and spine, history of trauma and skeletal-muscular damage in the upper limb, any protrusion of the disc in the cervical vertebrae or damage in it, having any history of surgery in the upper limb Having any physical activity outside of the program of corrective exercises that affects the results of the research.
Intervention groups
Corrective exercises group: stretching, strength and endurance exercises for the head and shoulder areas for eight weeks and three one-hour sessions every week. Control group: no intervention
Main outcome variables
Upper body deformities
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230711058742N1
Registration date:2023-10-14, 1402/07/22
Registration timing:prospective
Last update:2023-10-14, 1402/07/22
Update count:0
Registration date
2023-10-14, 1402/07/22
Registrant information
Name
Fateme Yaghobi
Name of organization / entity
Bu-Ali Sina University in Hamadan
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1423
Email address
f.yaghobi@phe.basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2023-11-01, 1402/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of corrective exercises on head and shoulder posture, strength and endurance of neckmuscles in smartphone users
Public title
The effect of corrective exercises on the condition of the upper limbs in smartphone users
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subject receive or send at least 25 text messages or emails daily
The subject plays game at least one hour a day with a smart phone
The subject spends at least one hour of web surfing with a smart phone every day
In addition to the above the subject uses a smartphone for at least three hours a day
In order to ensure the consent of people to participate in this research a written consent form will be provided to them and all the possible risks of the test will be explained to the subjects People participating in the test are free to participate or not participate in the test and after declaring their agreement they can leave the test whenever they want
Exclusion criteria:
Congenital disorders and insufficiency in the neck and spine.
History of trauma and musculoskeletal injury in the upper limb.
Having any history of surgery in the upper limb.
Having any disc protrusion in the cervical vertebrae or damage in it.
Age
From 12 years old to 17 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done based on the Random Number Generator software, and they will be assigned to double groups based on the allocation concealment using the SNOSE method. The randomization of subjects is done in two stages. First, each of the subjects chooses a number between 1-40 using a lottery, then twenty random numbers are selected between the numbers 1-40 using the Random number generator software and according to the generated numbers And the selected numbers of subjects are divided into two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome assessors (laboratory technicians) are asked to take the desired tests from the clients. These people will be unaware of the purpose of the research, the allocation of study groups, and the reason for the subjects' presence in the laboratory, and they will only evaluate the variables and record their observations.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bu Ali Sina University
Street address
Bu Ali Sina University, Ahmadi Roshan Blvd, Hamadan Town
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2023-01-12, 1401/10/22
Ethics committee reference number
IR.BASU.REC.1402.021
Health conditions studied
1
Description of health condition studied
text neck syndrom
ICD-10 code
M54. 2
ICD-10 code description
M54. 2 is a billable/specific ICD-10-CM code that can be used to indicate a diagnosis for reimbursement purposes. The 2023 edition of ICD-10-CM M54.
Primary outcomes
1
Description
Head and shoulder angle
Timepoint
Before the intervention begins, one day after the end intervention
Method of measurement
Kinovea software
2
Description
The strength of neck muscles
Timepoint
Before the intervention begins, one day after the end intervention
Method of measurement
dynamometer
3
Description
The endurance of the neck muscles
Timepoint
Before the intervention begins, one day after the end intervention
Method of measurement
Field test and chronometer
4
Description
Flexibility of Pectoralis minor and Latissimus dorsi muscles
Timepoint
Before the intervention begins, one day after the end intervention
Method of measurement
scaled ruler
5
Description
Neck disability index
Timepoint
Before the intervention begins, one day after the end intervention
Method of measurement
NDI questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Corrective exercises group: The intervention will include stretching, strength and endurance exercises for the head and shoulders for 8 weeks and 3 sessions of 1 hour each week. Exercises do not require special equipment.
Category
Rehabilitation
2
Description
Control group: No Intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan Province General Department of Education
Full name of responsible person
Mahmoud Naqvi
Street address
Hamadan Province General Department of Education, Farhang Street, Taleqani Street, Hamadan Town
City
Hamadan
Province
Hamadan
Postal code
6515738448
Phone
+98 81 3825 1066
Email
dnp@medu.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Farzane Saki
Street address
Bu Ali Sina University, Ahmadi Roshan Blvd, Hamadan Town
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1423
Email
f.sport2008@gmail.com
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
Bu Ali Sina University of Hamadan
Full name of responsible person
Fateme Yaghobi
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Rehabilitation
Street address
Bu Ali Sina University, Ahmadi Roshan Blvd, Hamadan Town
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1423
Email
fa.yaghobi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bu Ali Sina University of Hamadan
Full name of responsible person
Fateme Yaghobi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Sport Rehabilitation
Street address
Bu Ali Sina University, Ahmadi Roshan Blvd, Hamadan Town
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1423
Email
fa.yaghobi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bu Ali Sina University of Hamedan
Full name of responsible person
Fateme Yaghobi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Sport Rehabilitation
Street address
Bu Ali Sina University, Ahmadi Roshan Blvd, Hamadan Town
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1423
Email
fa.yaghobi@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
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
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