Protocol summary

Study aim
Effect of 12 weeks of strength and stretching exercises on shoulder function, athletic performance and daily activities of wheelchair basketball players with shoulder pain
Design
This is a 12 week, prospective, parallel group, randomized controlled trial with 1: 1 allocation ratio in control and exercise groups..
Settings and conduct
The present study will be carried out at the University of Guilan. Because of nature of the study, the participants are not blind to the division into groups, but statisticians and evaluators split participants into groups.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Use manual wheelchair as a means of displacement (at least 50% of time), unilateral or bilateral shoulder pain that affected at least one function (eg, physical activity, and wheelchair use), Confirmation of one of the Neer and Hawkins-Kennedy tests, or pain with arm elevation. Exclusion criteria; Hospitalization due to acute injury, fracture, or shoulder surgery during the past year, injection of cortisone into shoulder over the past 4 months and participation in physiotherapy or shoulder exercise during the past year.
Intervention groups
The exercise intervention was based on interventions for shoulder pain in previous studies that included stretching (4 exercises) and strengthening (4 exercises) exercise. Strengthening exercise targeted serratus anterior muscle, scapular retractor and depurator muscles, and glenohumeral external rotator muscles and the stretching exercise aimed to increase flexibility of upper trapezius muscle, pectoralis major and minor muscles, and posterior glenohumeral capsule and underlying soft tissues.
Main outcome variables
Shoulder pain intensity, activities of daily living and sport skill and performance were assessed using the wheelchair user's shoulder pain index (WUSPI), Barthel Index and wheelchairs basketball field tests, respectively.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170114031942N9
Registration date: 2018-08-15, 1397/05/24
Registration timing: prospective

Last update: 2018-08-15, 1397/05/24
Update count: 0
Registration date
2018-08-15, 1397/05/24
Registrant information
Name
Aynollah Naderi
Name of organization / entity
Shahrood University of Technology
Country
Iran (Islamic Republic of)
Phone
+98 917 721 7462
Email address
ay.naderi@shahroodut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 12 weeks of stretch and strength exercise on shoulder function, sport performance and level of daily living activities in basketball wheelchair players with shoulder pain
Public title
Effect of stretch and strength exercise on performance of basketball wheelchair players with shoulder pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of one-sided or bilateral shoulder pain that affects at least one function (for example, sport activity, wheelchair use). Confirmation of one of the Neer and Hawkins-Kennedy tests, or pain with the arm elevation
Exclusion criteria:
Hospitalization due to acute injury, fracture, or shoulder surgery during the past year. Injection of cortisone into shoulder over the past 4 months. Participation in the physiotherapy duration or shoulder exercise therapy during the past year.
Age
From 25 years old to 40 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blocks randomization with blocks 2 and 4 is used to allocate the participants in the research groups. Participants allocation is carried out by one of the research team members who are not associated with the 1: 1 allocation ratio within the exercise and control groups. Allocation sequences are hidden by the envelopes encoded in the order numbered, and the letter envelopes are opened only after all the initial and initial evaluations of the participants have been made. A computerized list of random numbers for random allocation of subjects in blocks 2 and 4 is created by statistical consultant using SPSS software. Because of the nature of the study, evaluators and participants are not blinded from the groups allocation, but statistician is blinded.
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
University of Guilan
Street address
Qazvin Road, Persian Gulf Highway, Rasht
City
Rasht
Province
Guilan
Postal code
4199613776
Approval date
2018-07-09, 1397/04/18
Ethics committee reference number
IR.GUMS.REC.1397.184

Health conditions studied

1

Description of health condition studied
Shoulder pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Shoulder pain intensity
Timepoint
Measure shoulder pain intensity at the beginning of the study (before the intervention) and 12 weeks after the intervention .
Method of measurement
wheelchair user's shoulder pain index

2

Description
Activities of daily living
Timepoint
Measure daily activities at the beginning of the study (before the intervention) and 12 weeks after the intervention .
Method of measurement
Barthel Index

3

Description
Sport skill and performance
Timepoint
Measure sport skill and performance at the beginning of the study (before the intervention) and 12 weeks after the intervention .
Method of measurement
wheelchairs basketball field tests

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:. The exercise intervention was based on interventions for shoulder pain in previous studies that included stretching (4 exercises) and strengthening (4 exercises) exercise. Strengthening exercise targeted serratus anterior muscle, scapular retractor and depurator muscles, and glenohumeral external rotator muscles and the stretching exercise aimed to increase flexibility of upper trapezius muscle, pectoralis major and minor muscles, and posterior glenohumeral capsule and underlying soft tissues.
Category
Rehabilitation

2

Description
Control group: Continue daily activities.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Guilan
Full name of responsible person
Danyal Moslehpoor
Street address
Qazvin roads, Persian Gulf highways, Rasht, Guilan province
City
Rasht
Province
Semnan
Postal code
4199613776
Phone
+98 23 3239 2204
Email
Ay.naderi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Guilan
Full name of responsible person
Dayal Moslehpoor
Street address
Qazvin Roads, Persian Gulf highways, Rasht, Guilan Province
City
Rasht
Province
Semnan
Postal code
4199613776
Phone
+98 23 3239 2204
Email
ay.naderi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Guilan
Proportion provided by this source
100
Public or private sector
Private
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 Guilan
Full name of responsible person
Danyal Moslehpoor
Position
M.A student
Latest degree
Bachelor
Other areas of specialty/work
Sport scince
Street address
Gilan province, Rasht, Persian Gulf highways, Qazvin Roads
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 917 721 7462
Email
ay.naderi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Aynollah Naderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education and Sports Science
Street address
Tehran avenue, Shahroud, Semnan Province
City
Shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Fax
Email
ay.naderi@shahroodut.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Aynollah Naderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education and Sports Science
Street address
Tehran Avenue, Shahroud, Semnan Province
City
shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Email
Ay.naderi@yahoo.com

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 more 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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