Protocol summary

Summary
The objective of this study is to investigate the effect of general fatigue on balance tests (star, single leg stance and stork standing) scores in athletes with anterior cruciate ligament reconstruction and healthy athletes. In this study, 10 athletes with anterior cruciate ligament reconstruction and 10 healthy male athletes in the group aged 18-40 years will be selected through convenience sampling. To do the study after the warm up,the subject performs balance tests.Then for general fatigue the subject runs on treadmill according to Bruce protocol until reaches to fatigue. The fatigue is measured by the Borg scale and a minimum score of 15 is acceptable. Immediately after fatigue, the subject will do balance tests again.Finally, the effect of fatigue on the balance tests score will be investigate.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201506281552N4
Registration date: 2015-08-16, 1394/05/25
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-08-16, 1394/05/25
Registrant information
Name
Maryam Ebrahimian
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1551
Email address
ebrahimian@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs of Shiraz University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-10-07, 1394/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the Effect of General Fatigue on Balance Tests Scores in Athletes with Anterior Cruciate Ligament Reconstruction
Public title
Investigation of the Effect of General Fatigue on Balance Tests Scores in Athletes with Anterior Cruciate Ligament Reconstruction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Unilateral rupture of the anterior cruciate ligament; no neurological diseases and cardiovascular disorders; absence of deformity in the lower extremity; full range of motion knee, hip and ankle joints; no other ligament tear of the knee; absence of any fracture in the lower extremity; Exclusion criteria: Having pain during the tests; inability to complete the fatigue protocol
Age
From 18 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
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
Shiraz University of Medical Sciences
Street address
in front of Felestin St., Zand Ave.
City
Shiraz
Postal code
1433671348
Approval date
2014-12-14, 1393/09/23
Ethics committee reference number
CT-P-9373-7103

Health conditions studied

1

Description of health condition studied
Anterior cruciate ligament rupture
ICD-10 code
S83.5
ICD-10 code description
Sprain and strain involving (anterior)(posterior) cruciate ligament of knee

Primary outcomes

1

Description
Balance tests score
Timepoint
Before and after general fatigue
Method of measurement
recording balance tests score

Secondary outcomes

empty

Intervention groups

1

Description
In intervention group 1, general fatigue applies with Bruce protocol
Category
Prevention

2

Description
In intervention group 2, general fatigue applies with Bruce protocol
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation Sciences School of Shiraz University of Medical Sciences
Full name of responsible person
Esmaeil Shokri
Street address
Abiverdi No.1 St., Shahid Chamran Blvd.
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research Affirs of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Sayed Basir Hashemi
Street address
7th fioor of Central Building of Shiraz University of Medi cal Sciences,In front of Felestin Street, Zand Avenue.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research Affirs of Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Rehabilitation Sciences School of Shiraz University of Medical Sciences
Full name of responsible person
Zahra Abid
Position
B.S student of physiotherapy
Other areas of specialty/work
Street address
No.182, line 38, West Mirzaye Shirazi Blv
City
Shiraz
Postal code
7196736644
Phone
+98 71 3635 1494
Fax
Email
abidpt88@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rehablitation Sciences School of Shiraz Univercity of Medical Sciences
Full name of responsible person
Maryam Ebrahimian
Position
master of science/faculty member
Other areas of specialty/work
Street address
Abiverdi No.1 St., Shahid Chamran Blvd.
City
Shiraz
Postal code
7194733669
Phone
+98 71 3627 1552
Fax
+98 71 1627 2495
Email
ebrahimian@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rehablitation Sciences School of Shiraz Univercity of Medical Sciences
Full name of responsible person
Maryam Ebrahimian
Position
master of science/faculty member
Other areas of specialty/work
Street address
Abiverdi No.1 St., Shahid Chamran Blvd.
City
Shiraz
Postal code
7194733669
Phone
+98 71 3627 1552
Fax
+98 71 1627 2495
Email
ebrahimian@sums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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