The Impact of Different Methods of Constraint-led Approach and Visual-Motor Training on Selected Neuroplasticity, psycology and Functional Variables in the Patients with the History of Anterior Cruciate Ligament Reconstruction
The Impact of Different Methods of Constraint-led Approach and Visual-Motor Training on Selected Neuroplasticity, psychologyand Functional Variables in the Patients with the History of Anterior Cruciate Ligament Reconstruction
Design
The study consists of two parallel groups and one control group. The sample size is based on previous selected articles on 45 people
Settings and conduct
FMRI test at National Brain Mapping Laboratory and Biomechanical Test at Biomechanics Laboratory of Shahid Beheshti Rehabilitation School and two months of training at the University Stadium
Participants/Inclusion and exclusion criteria
Age between 18 and 45 years
Having general health at the discretion of the physician
No pain or swelling in the knee area
Have at least four years of experience in sports
6 months to a year after surgery
Intervention groups
Intervention Group 1: Investigating the Impact of Visual Motor training
Intervention group 2: The effect of different methods of the Constraint-led Approach
Intervention group 3: The control group is without any training intervention
Main outcome variables
Help improve rehabilitation for patients by reconstructing the anterior cruciate ligament ligament and repairing the brain (neuroplasticity) and improving psychological factors such as fear of injury and kinophobia and functional factors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200223046598N1
Registration date:2020-05-10, 1399/02/21
Registration timing:retrospective
Last update:2020-05-10, 1399/02/21
Update count:0
Registration date
2020-05-10, 1399/02/21
Registrant information
Name
Fateme Gholami
Name of organization / entity
The University Of Kharazmi
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 2600
Email address
std_gholami_f@khu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-16, 1398/08/25
Expected recruitment end date
2020-01-30, 1398/11/10
Actual recruitment start date
2020-01-25, 1398/11/05
Actual recruitment end date
2020-02-05, 1398/11/16
Trial completion date
2020-02-05, 1398/11/16
Scientific title
The Impact of Different Methods of Constraint-led Approach and Visual-Motor Training on Selected Neuroplasticity, psycology and Functional Variables in the Patients with the History of Anterior Cruciate Ligament Reconstruction
Public title
The effect of Visual-Motor Training on Neuroplasticity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having general health at the discretion of the physician
Perform surgery on the anterior cruciate ligament
6 months to a year after surgery
Exclusion criteria:
No pain or swelling in the knee area
Lack of lower limb abnormalities
Age
From 18 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Actual sample size reached:
45
Randomization (investigator's opinion)
Not randomized
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
کمیته ملی اخلاق در پژوهش های زیست پزشکی
Street address
Tehran, Ghods Town (West), between Flamak South and Zarafshan, Simai St., Iran, Central Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th Floor
City
Tehran
Province
Tehran
Postal code
71869_11817
Approval date
2020-01-20, 1398/10/30
Ethics committee reference number
IR.KHU.REC.1398.049
Health conditions studied
1
Description of health condition studied
Patients with anterior cruciate ligament reconstruction
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Restoration of cerebral areas, including the motor cortex after training, improves performance in knee flexion / extension, and valgus .reduces fear of injury and kinophobia after exercise
Timepoint
After 8 weeks of training
Method of measurement
نوروپلاستیسیتی: اندازه گیری با FMRI، عوامل عملکردی با:موشن و فورس پلیت و همچنین عوامل روانشناختی با پرسشنامه
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: visual training is a movement that is the basis of jumping and landing exercises with balance movement and resistance and visual disturbance and with the use of tools such as Traband, Busobal, balance board. The second intervention group: the constraints_led approach that change the environment and homework in these exercises as well as the person himself, for example, the person exercises with fatigue and without fatigue or in a bright and dark environment.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Behnam Physiotherapy Clinic
Full name of responsible person
Dr. Soheil Mansour Sohani
Street address
Tehran, Shariati St., Ershad dead end
City
Tehran
Province
Tehran
Postal code
7186911817
Phone
+98 21 2289 5939
Email
std_gholami_f@khu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Kharazmi
Full name of responsible person
amir letafatkar
Street address
Hesari st
City
Tehran
Province
Tehran
Postal code
7186911817
Phone
+98 21 8832 9220
Email
letafatkaramir@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Kharazmi
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
The University Of Kharazmi
Full name of responsible person
Fateme Gholami
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Corrective exercise and sport injury
Street address
Somaye street
City
Tehran
Province
Tehran
Postal code
7186911817
Phone
+98 21 8888 2600
Fax
Email
std_gholami_f@khu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
the University of Kharazmi
Full name of responsible person
Fateme Gholami
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Corrective exercise and sport injury
Street address
Somaye street
City
Tehran
Province
Tehran
Postal code
7186911817
Phone
+98 21 8888 2600
Fax
Email
std_gholami_f@khu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University Of Kharazmi
Full name of responsible person
Fateme Gholami
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Corrective exercise and sport injury
Street address
Somaye street
City
Tehran
Province
Tehran
Postal code
7186911817
Phone
+98 21 8888 2600
Fax
Email
std_gholami_f@khu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data related to people's information, including the area undergoing surgery and reconstruction, age, height and bmi, and their level of athletic activity
When the data will become available and for how long
The course starts up to 5 to 8 months after printing the results
To whom data/document is available
Researchers studying at academic institutions or physicians and physiotherapists
Under which criteria data/document could be used
People can ask the researcher for information or data by informing them
From where data/document is obtainable
researcher : std_gholami-f@gmail.com
What processes are involved for a request to access data/document
If the results are out of print, they will be available to people