Protocol summary

Study aim
aimed to evaluate effect of 8 week selective corrective exercise programme on upper quadrant pasture and pasture, Electromyography. Isokinetic strength and range of motion in person with forward head posture
Design
The randomized controlled trial is a single blinded with a pre and post-test design. 36 people will participate in this study and will assign to two groups of training and control with 1:1 ratio, based on computer generated algorithm
Settings and conduct
before and after intervention, Head angle will be measured by photogrammetry, neck range of motion by universal goniometer by Clarkson method, and neck muscle surface activity by biometric electromyography with surface electrodes. The main evaluator is not aware of how individuals are assigned to the groups. participated were asked not to talk about the exercises they were taking with the assessor or anyone else who was not attending the training sessions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Men with head forward more than 46 degrees, lack of regular participation in overhead activities , Exclusion criteria: history of surgery or fracture of the upper limbs and neck, scoliosis
Intervention groups
exercise group will receive corrective exercise program included stretching, strengthening, and stabilization exercises This 8-week training program will perform with three sessions per week, each lasting <50 minutes The control group does not receive any intervention. Participants confirmed that they did not undertake any specific exercise for their neck and shoulder griddle muscles during the duration of the study; however after the last measurement, they were offered a 1-hour individually supervised instruction of the exercise program.
Main outcome variables
A change in head posture, muscle strength and electromyography, head and shoulder range of motion

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200203046364N1
Registration date: 2021-11-18, 1400/08/27
Registration timing: retrospective

Last update: 2021-11-18, 1400/08/27
Update count: 0
Registration date
2021-11-18, 1400/08/27
Registrant information
Name
Rasoul Arshadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 4526 4408
Email address
rasoul.arshady@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-11, 1400/04/20
Expected recruitment end date
2021-08-11, 1400/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of eight week corrective exercise programme on pasture, Electromyography. Isokinetic strength and range of motion shoulder and neck in person with forward head posture
Public title
The effect of a 8-week exercise program on head posture, muscle strength and muscle activity and neck and shoulder range of motion
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
fhp angle above 46, having not regular participation in overhead activities
Exclusion criteria:
Having a history of surgery or fractures of upper limbs or spine over the past year scoliosis neurologic disease
Age
From 20 years old to 25 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 35
Randomization (investigator's opinion)
Randomized
Randomization description
computer-based randomization was performed in a 1:1 ratio to exercise group or control group, using computer-generated permuted-block randomization ( Random Allocation software version 1.0) with a random block size of 4 and 6. Sealed opaque envelopes were used to conceal random allocation. According to the sample size, letter envelopes were prepared and each of the random sequences was recorded on the card and placed in the letter envelopes, respectively. The letter envelopes were then stapled and placed in a box. Envelopes were also numbered in the same order to maintain a random sequence. Each participant opened one of the envelopes and thus allocation to each group was determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the assessors did not know which of the participants in the groups was being evaluated. To blind the assessors, they were not aware of the grouping of individuals (which group they were a member of). Also, the data analyzer was not aware of group allocation of participants. For this purpose, the data of groups was provided to the data analyzer in such a way that he was not informed about the grouping of individuals
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Azadi Sq., Isfahan university, sport science faculty
City
Isfahan
Province
Isfehan
Postal code
8174673441
Approval date
2018-02-24, 1396/12/05
Ethics committee reference number
IR.UI.REC.1396.044

Health conditions studied

1

Description of health condition studied
forward head posture
ICD-10 code
M62.9
ICD-10 code description
Disorder of muscle, unspecified

Primary outcomes

1

Description
muscle activity of neck and scapular muscle activity
Timepoint
before after corrective exercise implementation
Method of measurement
A portable surface EMG device (DataLog p3X8, Biometrics, UK)

2

Description
neck range of motion
Timepoint
Before training and one week after the end of the training program
Method of measurement
Neck range of motion assessed in sagittal plane by Universal goniometer (baseline, USA)

3

Description
head angle
Timepoint
Before training and one week after the end of the training program
Method of measurement
by A digital camera ( sony 14 megapixel, Japan) according photogrammetric method

4

Description
isiokinetic strength of shoulder
Timepoint
Before training and one week after the end of the training program
Method of measurement
shoulder strength was measured at 45 degree of shoulder abduction and 90 degree of elbow flexion by isokinetic dynamometer ( biodex system 4 )

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The training program included stretching, strengthening, and stabilization exercises This 8-week training program will be performed with three sessions per week, each lasting <50 minutes. To enhance exercise efficacy, exercise variation was set according to the ACSM recommendations. All training sessions contained three phases: standard warm-up, the main part, and cool-down. the duration of the stretching exercises will be 30 seconds for the initial sessions, which will be added five more seconds every two weeks . Carnicervical flextion training consisted of movements that will be done without any load in prone and quadruped positions; and progression in these movements will be based on an increase in the repetition of correct movement, duration of holding given position, and the range of motion, as well.
Category
Rehabilitation

2

Description
Control group: Control group: will not do any special exercises, they are only asked to avoid participating in overhead activities or any strengthening activities that affect the upper quadrant area.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz medical science university
Full name of responsible person
Rasoul arshadi
Street address
29 bahman ave, university of tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3334 4273
Email
asgri@tabrizu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
university of Isfahan
Full name of responsible person
Gholam ali Ghasemi
Street address
Azadi Sq., Isfahan university, sport science faculty
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2571
Email
Gh.ghasemi@spr.ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
university of Isfahan
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
University of Isafahan
Full name of responsible person
Rasoul Arshadi
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
posture health provider
Street address
Azadi Sq., Isfahan university, sport science faculty
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2571
Email
rasoul.arshady@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
university of Isfahan
Full name of responsible person
Gholam Ali Ghasemi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
corrective exercise and sports injuries
Street address
Azadi Sq., Isfahan university, sport science faculty
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2571
Email
Gh.ghasemi@spr.ui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
university of Isfahan
Full name of responsible person
Gholam Ali Ghasemi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
corrective exercise and sports injuries
Street address
Azadi Sq., Isfahan university, sport science faculty
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2571
Email
Gh.ghasemi@spr.ui.ac.ir

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
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
related data about outcomes
When the data will become available and for how long
one year after the publication of the article
To whom data/document is available
researchers, university students
Under which criteria data/document could be used
for study porpose
From where data/document is obtainable
Gholam Ali Ghasemi. Department of Sport Injuries and Corrective Exercises, Faculty of Sport Sciences, University of Isfahan, Isfahan, Iran
What processes are involved for a request to access data/document
Contact with Correspond author via Official Email
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