The purpose of the present study was to investigate the effect of functional stability training on selected neuromechanical factors in athletes after ACL reconstruction.
Design
A clinical trial with a control group, with parallel groups, single-blinded, randomized
Settings and conduct
The tests will be carried out by the specialists at the Sport Rehabilitation Laboratory of Bu-Ali Sina University in Hamadan, and then interventions and exercises will take place in the gym. During the testing, the participant will be unaware of the main purpose of the research.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: Athletes aged 15-30 years who have undergone ACL reconstruction surgery and their surgical technique including hamstring tendon implantation, athletes complete rehabilitation course and return to exercise, having at least 4 years experience Club sports, lack of injury history in the past 6 months, and activity in one of the volleyball or wrestling basketball disciplines and exclusion criteria include failure to participate in research, absence of more than two sessions of training sessions, surgery each Two feet.
Intervention groups
Functional stability training group, Control group
Main outcome variables
Anterior cruciate ligament injury
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190224042827N2
Registration date:2019-12-19, 1398/09/28
Registration timing:retrospective
Last update:2019-12-19, 1398/09/28
Update count:0
Registration date
2019-12-19, 1398/09/28
Registrant information
Name
Farzane Ramezani
Name of organization / entity
Bu Ali Sina University
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1423
Email address
f.ramezani@phe.basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-01, 1396/12/10
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
2018-04-04, 1397/01/15
Actual recruitment end date
2018-05-21, 1397/02/31
Trial completion date
2018-08-06, 1397/05/15
Scientific title
The Effect of Functional Stabilization Exercise on Selected Neuromechanical Factors in Athletes After Anterior Cruciate Ligament Reconstruction (ACLR)
Public title
The Effect of Functional Stability Exercises on Athletes After Anterior Cruciate Ligament Reconstruction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Athletes who have undergone anterior cruciate ligament reconstruction with hamstring tendon graft surgery.
Athletes who have completed a full rehabilitation course and returned to the sport.
Having at least 4 years of club sporting experience.
No history of injury in the past 6 months.
Working in one of the volleyball or wrestling, soccer, basketball fields.
Exclusion criteria:
Surgery of both legs.
Age
From 15 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
26
Actual sample size reached:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Random Number Generator software is randomized.
Blinding (investigator's opinion)
Double blinded
Blinding description
Individuals will be assigned to dual groups based on SNOSE allocation concealment. In this method, based on the sample size of the research, a number of envelopes are prepared and each random sequence created is recorded on a card and the cards are inserted into the letter envelopes respectively. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same manner. Finally, the lid envelopes are attached and placed in a box, respectively. At the beginning of the registration of participants according to the order of entry of the eligible participants into the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Approval date
2018-02-24, 1396/12/05
Ethics committee reference number
IR.UMSHA.REC.1396.840
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Selected Neuromechanical Factors
Timepoint
Before the intervention begins, One day after the end of the intervention
Method of measurement
Y balance test, the dynamometer, the McGill endurance tests, Hoop Tests and the digital camera
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Functional stability exercises, exercises will last 8 weeks and 3 sessions 1 hour each week, no special equipment is needed to perform the exercises.
Category
Rehabilitation
2
Description
Control group: No Intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan province General Administration of Sport
Full name of responsible person
Hossein Shafiei
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
f.sport2008@gmail.com
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, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
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
Full name of responsible person
Hossein Shafiei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Rehabilitation
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
f.sport2008@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Hossein Shafiei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Rehabilitation
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
f.sport2008@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Hossein Shafiei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Rehabilitation
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
f.sport2008@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