Protocol summary

Study aim
The survey effect of traditional and TRX exercises on scapular kinematics, range of motion, ratio of external rotation to internal rotation strength, proprioception and shoulder muscles activation in overhead athletes with shoulder impingement syndrome
Design
in this study, 33 athletes with shoulder impingement syndrome were selected by physiotherapist. Then they were randomly divided into three groups
Settings and conduct
This research is conducted in Kerman School of Sport Sciences for 8 weeks in three groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Unilateral pain for more than one week in the Acromion process; Pain during flexion and abduction versus resistance; Positive test for Neer, Hawkins and supraspinatus empty can; Pain when touched in Humerus tuberosity; Physical examination by the physiotherapist and confirmation of shoulder impingement syndrome Exclusion criteria:Systemic illnesses;neck pain at rest or neck pain during active cervical movements; History of neck pain or treatment to neck over the past 12 months; History of spinal or upper limb surgery, History of spinal or upper limb fractures,Presence of a positive sulcus sign; Presence of a positive load and shift test
Intervention groups
The first intervention group that received traditional exercises The second intervention group received the trx training The control group received their usual daily activities
Main outcome variables
scapular kinematics, range of motion, ratio of external rotation to internal rotation strength, proprioception and shoulder muscles activation levels

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171222037994N1
Registration date: 2018-05-18, 1397/02/28
Registration timing: retrospective

Last update: 2018-05-18, 1397/02/28
Update count: 0
Registration date
2018-05-18, 1397/02/28
Registrant information
Name
aboozar saadatian
Name of organization / entity
SHahid Bahonar University of kerman
Country
Iran (Islamic Republic of)
Phone
+98 34 3281 2777
Email address
aboozar.saadat67@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-01, 1396/09/10
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
2017-12-01, 1396/09/10
Actual recruitment end date
2018-01-20, 1396/10/30
Trial completion date
empty
Scientific title
A comparison effect of traditional and total body resistance exercise(TRX) exercises on scapular kinematics, range of motion, ratio of external rotation to internal rotation strength, proprioception and shoulder muscles activation in overhead athletes with shoulder impingement syndrome
Public title
effect exercise on impingement syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Unilateral pain for more than one week in the acromion ; Pain during flexion and abduction versus resistance; Positive test for Neer,Hawkins and supraspinatus empty can; Pain when touched in Humerus tuberosity; Physical examination by the physiotherapist and confirmation of shoulder impingement syndrome
Exclusion criteria:
Systemic illnesses neck pain at rest, or neck pain during active cervical movements History of cervical pain or treatment to this region over the past 12 months History of spinal or upper limb surgery History of spinal or upper limb fractures Presence of a positive sulcus sign and load and shift test
Age
From 18 years old to 43 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 36
Actual sample size reached: 33
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization of this study is Restricted. Method of implementation randomization is the block randomization, which to randomize subjects into groups that result in equal sample sizes. This method is used to ensure a balance in sample size across groups over time.At first, the sample size will be evaluated by the physiotherapist in terms of Inclusion and Exclusion criteria.The block size will be determined by the researcher and should be a multiple of the number of groups ( with three treatment groups, block size of either 33). than For each person in the sample, a code is determined which is placed in the envelope . Envelopes will be shuffled together and the envelope will be exited and re-shuffled.The first envelope in the first group is the second envelope in the second group and etc. for Allocation concealment will be used of method Sequentially numbered, sealed, opaque envelopes. After a random sequence created based on the sample size of the research, a number of envelopes are prepared and each random sequence created on the card is recorded and the cards are inserted into the envelopes respectively. In order to maintain a random sequence on the outer surface of the envelope, the numbering is done in the same order and will be pasted in the envelopes. At the time of the start of the registration of the participants, one of the envelopes will be opened based on entry of the participants, and the participant's group will be revealed
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman Neuroscience Research Center, Somayeh Cross, In Front of Besat Clinic, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7619813159
Approval date
2017-11-14, 1396/08/23
Ethics committee reference number
IR.Kmu.REC.1396.16

Health conditions studied

1

Description of health condition studied
Shoulder impingement syndrome
ICD-10 code
M75.4
ICD-10 code description
Impingement syndrome of shoulder

Primary outcomes

1

Description
scapular kinematics
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
motion analyzer

2

Description
range of motion
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
motion analyzer

3

Description
ratio of external rotation to internal rotation strength
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
Handheld Dynamometer

4

Description
proprioception
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
leighton flexometer

5

Description
shoulder muscles activation
Timepoint
Before the intervention and 8 weeks after the intervention
Method of measurement
motion analyzer

Secondary outcomes

empty

Intervention groups

1

Description
traditional exercises:These exercises are customary and based on previous studies that were used to rehabilitate the shoulder impingement syndrome. These exercises will be performed in 8 weeks and 3Session in each week and each Session 45 minutes . This 45 minutes includes 10 minutes of warming up to 30 minutes of main exercises and 5 minutes of cooing.The tool is used in these exercises thraband and free weights
Category
Rehabilitation

2

Description
TRX exercises:These exercises are also based on the latest available resources for shoulder joint rehabilitation. these exercises will be performed in 8 weeks and 3Session in each week and each Session 45 minutes . This 45 minutes includes 10 minutes of warming up to 30 minutes of main exercises and 5 minutes of cooing.The tool used in these exercises is suspension strap TRX
Category
Rehabilitation

3

Description
Control group: This group performs its usual daily and sporting activities
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Sanat Mes Kerman F.C
Full name of responsible person
Aboozar Saadatian
Street address
Alley next to Iran Trade Organization, Imam Khomeini Highway,Kerman, Iran
City
Kerman
Province
Kerman
Postal code
76169۷۶۱۳۴
Phone
+98 34 3216 3700
Email
aboozarsaadatian@yahoo.com

2

Recruitment center
Name of recruitment center
SHahid Bahonar University of Kerman
Full name of responsible person
Mansore Sahebozamani
Street address
Kerman-Imam Khomeini Highway, Research Area, Faculty of sports science, Shahid Bahonar University, Iran
City
Kerman
Province
Kerman
Postal code
7616914111
Phone
+98 34 3281 2777
Email
sahebozamani@yahoo.com

3

Recruitment center
Name of recruitment center
CHamran University of Kerman
Full name of responsible person
Akbar CHavoshian
Street address
Beginning of Highway the Haft Alavi Garden, Shaheed Mostafa Khomeini Street, Kerman,Iran
City
Kerman
Province
Kerman
Postal code
7635114311
Phone
+98 34 3325 7741
Email
infonamad@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
SHahid Bahonar University of Kerman
Full name of responsible person
Masoure Sahebozamani
Street address
Kerman-Imam Khomeini Highway-Research Area-Shahid Bahonar University
City
Kerman
Province
Kermanshah
Postal code
7616914111
Phone
+98 34 3281 2777
Email
sahebozamani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
SHahid Bahonar University of Kerman
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 Bahonar University of Kerman
Full name of responsible person
Aboozar Saadatian
Position
PHD student
Latest degree
Master
Other areas of specialty/work
sport injury and corrective exercise
Street address
Kerman-Imam Khomeini Highway-Research Area-Shahid Bahonar University
City
Kerman
Province
Kerman
Postal code
7616914111
Phone
+98 34 3281 2777
Email
aboozar.saadat67@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
SHahid Bahonar University of Kerman
Full name of responsible person
Aboozar Saadatian
Position
PHD student
Latest degree
Master
Other areas of specialty/work
spotrs injury and corrective exercise
Street address
Shahid Bahonar University, Research Area,Imam Khomeini Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7616914111
Phone
+98 34 3281 2777
Fax
Email
aboozar.saadat67@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
SHahid Bahonar University of Kerman
Full name of responsible person
Aboozar Saadatian
Position
PHD student
Latest degree
Master
Other areas of specialty/work
Sport injury and corrective exercise
Street address
SHahid Bahonar University of Kerman,Emam khomeni Blvd
City
Kerman
Province
Kerman
Postal code
7616914111
Phone
+98 34 3281 2777
Fax
Email
aboozar.saadat67@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
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
With the permission of the supervisor All information is being shared after non-identifiable
When the data will become available and for how long
Start access 6 months after printing results in article and By obtaining permission from the relevant university
To whom data/document is available
There is no limit
Under which criteria data/document could be used
Except for personal data, there are no restrictions on the rest
From where data/document is obtainable
Contact Mr. Aboozar Saadatian
What processes are involved for a request to access data/document
Contact with Mr. Abuoozar Saadatian and coordination with the Department of Sports injury at Shahid Bahonar University of Kerman. Information is available.
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