Comparison the effect of gait retraining along with feedback with rehabilitation targeting exercises on trunk and lower extremity kinetic and kinematic of patients with groin pain.
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General information
48
51
4851
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48
48
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2020-05-04, 1399/02/15
2020-05-04 00:00:00
empty
2020-07-08, 1399/04/18
2020-07-08 00:00:00
empty
2020-10-20, 1399/07/29
2020-10-20 00:00:00
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Enter information about the realized sample size, the start and end dates of the realized patient, and the end date of the clinical trial.
Enter information about the realized sample size, the start and end dates of the realized patient, and the end date of the clinical trial.
empty
وارد کردن اطلاعات مربوط به حجم نمونه تحقق یافته، تاریخ شروع و پایان بیمارگیری تحقق یافته، و تاریخ خاتمه کارآزمایی بالینی.
وارد کردن اطلاعات مربوط به حجم نمونه تحقق یافته، تاریخ شروع و پایان بیمارگیری تحقق یافته، و تاریخ خاتمه کارآزمایی بالینی.
Recruitment centers
#1
Name of recruitment center - English: Tehran football clubs
Name of recruitment center - Persian: باشگاه های فوتبال تهران
Full name of responsible person - English: Amir Letafatkar
Full name of responsible person - Persian: امیر لطافت کار
Street address - English: Tehran, End of Mirdamad, End of South Razan Street, Shahid Keshvari Complex, School of Physical Education and Sport Sciences
Street address - Persian: انتهای میرداماد - انتهای خیابان رازان جنوبی - مجموعه شهید کشوری -دانشکده تربیت بدنی و علوم ورزشی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۴۳۹۸۱۵۸۷۵
Phone: +98 21 2222 8001
Fax:
Email: AMIR.LETAFATKAR@KHU.AC.IR
Web page address:
Name of recruitment center - English: Tehran football clubs
Name of recruitment center - Persian: باشگاه های فوتبال تهران
Full name of responsible person - English: Amir Letafatkar
Full name of responsible person - Persian: امیر لطافت کار
Street address - English: Center for Human Movement Sciences Kharazmi University, End of Mirdamad, Sout Razan Street, Hesari Street, Keshvari Sport Complex.
Street address - Persian: مجموعه ورزشی کشوری، خیابان حصاری، خیابان رازان جنوبی، انتهای میرداماد، مرکز علوم حرکتی انسانی دانشگاه خوارزمی.
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۴۳۹۸۱۵۸۷۵
Phone: +98 21 2222 8001
Fax:
Email: AMIR.LETAFATKAR@KHU.AC.IR
Web page address:
Name of recruitment center - English: Tehran football clubs Name of recruitment center - Persian: باشگاه های فوتبال تهران Full name of responsible person - English: Amir Letafatkar Full name of responsible person - Persian: امیر لطافت کار Street address - English: TehranCenter for Human Movement Sciences Kharazmi University, End of Mirdamad, End of SouthSout Razan Street, ShahidHesari Street, Keshvari Complex, School of Physical Education and Sport SciencesComplex. Street address - Persian: انتهای میرداماد - انتهایمجموعه ورزشی کشوری، خیابان حصاری، خیابان رازان جنوبی - مجموعه شهید کشوری -دانشکده تربیت بدنی و، انتهای میرداماد، مرکز علوم ورزشیحرکتی انسانی دانشگاه خوارزمی. City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۴۳۹۸۱۵۸۷۵ Phone: +98 21 2222 8001 Fax: Email: AMIR.LETAFATKAR@KHU.AC.IR Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: kharazmi University
Name of organization / entity - Persian: دانشگاه خوارزمی
Full name of responsible person - English: Amir Letafatkar
Full name of responsible person - Persian: امیر لطافت کار
Street address - English: Tehran, End of Mirdamad, End of South Razan Street, Shahid Keshvari Complex, School of Physical Education and Sport Sciences
Street address - Persian: انتهای میرداماد، انتهای خیابان رازان جنوبی، مجموعه شهید کشوری، دانشکده تربیت بدنی و علوم ورزشی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۴۳۹۸۱۵۸۷۵
Phone: +98 21 2222 8001
Fax:
Email: AMIR.LETAFATKAR@KHU.AC.IR
Web page address:
contact.organization_id:
Name of organization / entity - English: kharazmi University
Name of organization / entity - Persian: دانشگاه خوارزمی
Full name of responsible person - English: Amir Letafatkar
Full name of responsible person - Persian: امیر لطافت کار
Street address - English: Center for Human Movement Sciences Kharazmi University, End of Mirdamad, Sout Razan Street, Hesari Street, Keshvari Sport Complex.
Street address - Persian: مجموعه ورزشی کشوری، خیابان حصاری، خیابان رازان جنوبی، انتهای میرداماد، مرکز علوم حرکتی انسانی دانشگاه خوارزمی.
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۴۳۹۸۱۵۸۷۵
Phone: +98 21 2222 8001
Fax:
Email: AMIR.LETAFATKAR@KHU.AC.IR
Web page address:
contact.organization_id: Name of organization / entity - English: kharazmi University Name of organization / entity - Persian: دانشگاه خوارزمی Full name of responsible person - English: Amir Letafatkar Full name of responsible person - Persian: امیر لطافت کار Street address - English: TehranCenter for Human Movement Sciences Kharazmi University, End of Mirdamad, End of SouthSout Razan Street, ShahidHesari Street, Keshvari Complex, School of Physical Education and Sport SciencesComplex. Street address - Persian: انتهای میردامادمجموعه ورزشی کشوری، انتهایخیابان حصاری، خیابان رازان جنوبی، مجموعه شهید کشوریانتهای میرداماد، دانشکده تربیت بدنی ومرکز علوم ورزشیحرکتی انسانی دانشگاه خوارزمی. City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۴۳۹۸۱۵۸۷۵ Phone: +98 21 2222 8001 Fax: Email: AMIR.LETAFATKAR@KHU.AC.IR Web page address:
Protocol summary
Study aim
Comparison the effect of gait retraining along with feedback with rehabilitation targeting exercises on trunk and lower extremity kinetic and kinematic of patients with groin pain.
Design
The statistical population of the present study consists of men aged 18-35 with groin pain, among whom 48 people were selected based on the criteria for entering the research purposefully and randomly into two intervention groups and one control group (each group included 16 people) are divided. One group performs targeted rehabilitation interventions, and the other group undergoes gait retraining along with visual and verbal feedback. The control group also continues the special routine exercises of their sport.
Settings and conduct
The study was performed on footballers with groin pain in the Kharazmi University Correctional Laboratory. Squeeze test is used to evaluate the pain variable, and motion analysis systems are used to evaluate the kinetic and kinematic variables during a cutting maneuver. These assessments are pre and post test. In this research, the evaluator is kept blind, so that one researcher who has no knowledge of how to allocate subjects in groups, performs the evaluation.
Participants/Inclusion and exclusion criteria
Inclusion criteria: groin pain history; intention to return to competitive sports; positive Squeeze testing; painful touch on the adductor tendon. Exclusion criteria: hip joint osteoarthritis; primary medical conditions; pain in the thoracolumbar area; performing hip adductor strengthening exercises.
Intervention groups
Intervention Group 1: This group receives rehabilitation exercises at three levels. Intervention Group 2: This group receives a gait retraining program along with visual and verbal feedback. Control group: This group continues the specific routine exercises of their sport.
Main outcome variables
Groin pain; Kinetic; Kinematic
General information
Reason for update
Enter information about the realized sample size, the start and end dates of the realized patient, and the end date of the clinical trial.
Acronym
IRCT registration information
IRCT registration number:IRCT20200401046908N1
Registration date:2020-05-02, 1399/02/13
Registration timing:prospective
Last update:2020-10-20, 1399/07/29
Update count:1
Registration date
2020-05-02, 1399/02/13
Registrant information
Name
Sarvenaz Kazempour
Name of organization / entity
Kharazmi University
Country
Iran (Islamic Republic of)
Phone
+98 11 4226 7159
Email address
std_kazempoursarvenaz@khu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-13, 1399/01/25
Expected recruitment end date
2020-06-17, 1399/03/28
Actual recruitment start date
2020-05-04, 1399/02/15
Actual recruitment end date
2020-07-08, 1399/04/18
Trial completion date
2020-10-20, 1399/07/29
Scientific title
Comparison the effect of gait retraining along with feedback with rehabilitation targeting exercises on trunk and lower extremity kinetic and kinematic of patients with groin pain.
Public title
Comparison of gait retraining intervention along with feedback with rehabilitation targeting exercises on biomechanics of patients with groin pain.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men 18-35 years old have groin pain for at least 2 months
People who intend to return to the same level of preinjury participation in competitive multidirectional sports
Those who have a positive Squeeze test (at 45 degrees of hip flexion)
Those who have painful palpation in the tendon of the adductor or its connections to the pubic bone
Exclusion criteria:
People with hip joint osteoarthritis
Those with underlying medical conditions such as arthritis or infection
People who feel pain in the thoracolumbar area
Athletes who performed hip adductor strengthening exercises more than once a week for six months before the study
Age
From 18 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
51
Actual sample size reached:
48
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize, the names of each subject are written on a ball after being selected and placed inside a bag, and a person is asked to take them out of the bag and randomly place 1: 1: 1 in one of three study groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
One researcher who is evaluating the outcome is kept blind. In this way, he does not know how the subjects are assigned to the groups and what treatment interventions each group of subjects receives. In this way, he does not make deliberate mistakes in his judgments and does not benefit from the new treatment intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Kharazmi University Research
Street address
Center for Human Movement Sciences Kharazmi University, End of Mirdamad, Sout Razan Street, Hesari Street, Keshvari Sport Complex.
City
Tehran
Province
Tehran
Postal code
۴۳۹۸۱۵۸۷۵
Approval date
2020-01-12, 1398/10/22
Ethics committee reference number
IR.KHU.REC.1398.056
Health conditions studied
1
Description of health condition studied
Groin pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Groin Pain
Timepoint
Pre and post test
Method of measurement
sphygmomanometer
Secondary outcomes
1
Description
Kinetic: Ankle moment sagittal (plantar)
Timepoint
Pre and post test
Method of measurement
Force plate
2
Description
Kinetic: Ankle power sagittal (eccentric)
Timepoint
Pre and post test
Method of measurement
Force plate
3
Description
Kinetic: Ankle power sagittal (concentric)
Timepoint
Pre and post test
Method of measurement
Force plate
4
Description
Kinetic: Hip power sagittal (concentric)
Timepoint
Pre and post test
Method of measurement
Force plate
5
Description
Kinetic: Hip moment sagittal (extensor)
Timepoint
Pre and post test
Method of measurement
Force plate
6
Description
Kinetic: Knee power sagittal (concentric)
Timepoint
Pre and post test
Method of measurement
Force plate
7
Description
Kinetic: Hip moment frontal (adductor)
Timepoint
Pre and post test
Method of measurement
Force plate
8
Description
Kinematic: Thorax angles frontal (contralateral side flexion)
Intervention group 1: This group will implement a targeted rehabilitation protocol that includes three levels; level 1 addressed intersegmental control and strength, level 2 involved linear running mechanics and increasing linear running load tolerance, and level 3 targeted multidirectional mechanics and the transition back to high intensity sprinting. Exercises are performed 3 days a week, one day in between, for 8 weeks. The rest time between each set is 30 seconds to 1 minute.
Category
Treatment - Other
2
Description
Intervention group 2: This group performs gait retraining along with visual and verbal feedback. Gait retraining is done on a treadmill. People run on the treadmill at a comfortable pace in all sessions. Visual feedback during running through a full-length mirror that is placed directly in front of the treadmill, and verbal feedback in the form of instructions such as "keeping the knees in line with the toes, reducing pelvic prolapse and maintaining pelvic symmetry, reducing vertical acceleration (by inducing a quiet and quiet walking style)" provided by the tester. In general, the training time starts from 15 minutes in the first session and is increased to 3 to 9 minutes per week. While feedback time is reduced from 100% in the first four weeks to 25% in the last few weeks and then removed. Exercises are followed 1 day a week for 8 weeks.
Category
Treatment - Other
3
Description
Control group: This group continues the specific routine exercises of their sport.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran football clubs
Full name of responsible person
Amir Letafatkar
Street address
Center for Human Movement Sciences Kharazmi University, End of Mirdamad, Sout Razan Street, Hesari Street, Keshvari Sport Complex.
City
Tehran
Province
Tehran
Postal code
۴۳۹۸۱۵۸۷۵
Phone
+98 21 2222 8001
Email
AMIR.LETAFATKAR@KHU.AC.IR
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
kharazmi University
Full name of responsible person
Amir Letafatkar
Street address
Center for Human Movement Sciences Kharazmi University, End of Mirdamad, Sout Razan Street, Hesari Street, Keshvari Sport Complex.
City
Tehran
Province
Tehran
Postal code
۴۳۹۸۱۵۸۷۵
Phone
+98 21 2222 8001
Email
AMIR.LETAFATKAR@KHU.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
kharazmi University
Proportion provided by this source
50
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
kharazmi University
Full name of responsible person
Sarvenaz kazempour
Position
Student
Latest degree
Master
Other areas of specialty/work
Corrective Exercises and Sport Injuries
Street address
Between the 8th and 10th Yadgar, 16 Metri Dovom street.
City
Qaemshahr
Province
Mazandaran
Postal code
4766657165
Phone
+98 11 4226 7159
Email
Kazempour.sarvenaz@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
kharazmi University
Full name of responsible person
Sarvenaz Kazempour
Position
Student
Latest degree
Master
Other areas of specialty/work
Corrective Exercises and Sport Injuries
Street address
Between the 8th and 10th Yadgar, 16 Metri Dovom street.
City
Qaemshahr
Province
Mazandaran
Postal code
4766657165
Phone
+98 11 4226 7159
Email
Kazempour.sarvenaz@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
kharazmi University
Full name of responsible person
Sarvenaz Kazempour
Position
Student
Latest degree
Master
Other areas of specialty/work
Corrective Exercises and Sport Injuries
Street address
Between the 8th and 10th Yadgar, 16 Metri Dovom street.
City
Qaemshahr
Province
Mazandaran
Postal code
4766657165
Phone
+98 11 4226 7159
Email
Kazempour.sarvenaz@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 further information.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
Only part of the data, such as dependent variables, the average of all samples, can be shared in the form of scientific articles.
When the data will become available and for how long
Start accessing 6 months after publishing results in articles and obtaining permission from the relevant university.
To whom data/document is available
Personal information is confidential and general outcomes in paper form available to everyone.
Under which criteria data/document could be used
Information is not available to anyone. General outcomes in paper form available to everyone.
What processes are involved for a request to access data/document
Information can be provided by contacting Sarvanaz Kazempour and coordinating with the Department of Sports Pathology of Kharazmi University of Tehran.