The effect of neuromuscular training with neurocognitive training on selected psychological, functional and biomechanical factors in male athletes with anterior cruciate ligament reconstruction
The effect of neuromuscular training with neurocognitive training on selected psychological, functional and biomechanical factors in male athletes with anterior cruciate ligament reconstruction
Design
A clinical trial with a control group, with parallel groups, single blind, randomized, on 45 patients and random number table of Random Allocation Software will be used for randomization.
Settings and conduct
The present study will be conducted at the Kharazmi University. A total of 45 patients with anterior cruciate ligament reconstruction who are eligible for the study are randomly assigned to three groups. The training in intervention groups will be 16 sessions for 8 weeks. Outcome assessor is blind to the participants in each group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having the surgery of anterior cruciate ligament using auto graft hamstring for the first time, Passing 6 to 9 months after the surgery, Having at least 2 years of experience in the fields of Handball, Basketball, Football and Volleyball in the provincial level, Not having any specific pain and swelling in the knee, Aged between 18-30 , Having completed physiotherapy course, Lack of lower limb abnormalities؛ Exclusion criteria: Hearing and vision problems, Balance problems
Intervention groups
Intervention Group 1: neuromuscular training; Intervention group 2: neuromuscular training with neurocognitive training (Intervention groups 1 and 2 in an 8-week training program, 2 sessions per week for 60 minutes. Each training session will include 10 minutes of warm-up, 45 minutes of training program, and 5 minutes of cooling); Control group 3: The control group is without any training intervention.
Main outcome variables
Psychological, functional and biomechanical factors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211113053053N1
Registration date:2021-12-10, 1400/09/19
Registration timing:registered_while_recruiting
Last update:2021-12-10, 1400/09/19
Update count:2
Registration date
2021-12-10, 1400/09/19
Registrant information
Name
Hossein Tajdini
Name of organization / entity
Kharazmi University
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8001
Email address
h.tajdini@khu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-11-20, 1400/08/29
Expected recruitment end date
2022-01-15, 1400/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of neuromuscular training with neurocognitive training on selected psychological, functional and biomechanical factors in male athletes with anterior cruciate ligament reconstruction
Public title
The effect of neurocognitive training on rehabilitation of male athletes with anterior cruciate ligament reconstruction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 18-30
All patients who have first performed anterior cruciate ligament restoration using hamstring auto grafting method
Passing 6 to 9 months after the surgery
Having completed physiotherapy course
Having at least 2 years of experience in the fields of Handball, Basketball, Football and Volleyball in the provincial level
No swelling and pain in the knee
Lack of lower limb abnormalities
Exclusion criteria:
Hearing and vision problems
Balance problems
Participation in any rehabilitation program for anterior cruciate ligament
Age
From 18 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to 1 of 3 groups, the samples will be determined in a simple random method using a random number table of Random Allocation software. Randomization and allocation sequence for concealment will be done by the person not involved in the research. The ratio of sample allocation will be 1: 1 and will be divided into 2 experimental groups and 1 control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome assessor is kept blind. The assessor was blinded to the group allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Committee for Ethics in Biomedical Research
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
2021-06-21, 1400/03/31
Ethics committee reference number
IR.SSRC.REC.1400.065
Health conditions studied
1
Description of health condition studied
Anterior cruciate ligament reconstruction
ICD-10 code
S83.5
ICD-10 code description
Sprain of cruciate ligament of knee
Primary outcomes
1
Description
Dynamic knee valgus angle during landing
Timepoint
Before the intervention and the end of the intervention
Method of measurement
Motion analysis system
Secondary outcomes
1
Description
Psychological readiness
Timepoint
Before the intervention and the end of the intervention
Method of measurement
Anterior Cruciate Ligament Return - To - Sport after Injury
2
Description
Torque of the lower limb joints during landing
Timepoint
Before the intervention and the end of the intervention
Method of measurement
Motion analysis system and force plate
3
Description
Coordination and Coordination Variability
Timepoint
Before the intervention and the end of the intervention
Method of measurement
Motion analysis system
Intervention groups
1
Description
Intervention group 1: Performing neuromuscular training including single-legged exercises (single-legged hop and anterior progressions), posterior chain activation exercises (Romanian dead lift and lunge progressions), bilateral jumping exercises (double-legged jump progression), and core stability and trunk strengthening exercises (prone trunk stability and lateral trunk flexion progressions) with the use of tools such as Traband, Busobal, balance board during eight weeks, each week for two sessions (each session approximately 60 minutes).
Category
Rehabilitation
2
Description
Intervention group B: Performing neuromuscular training with cognitive and visual challenges such as counting numbers backwards, looking back and forth while performing neuromuscular training (single-legged exercises (single-legged hop and anterior progressions), posterior chain activation exercises (Romanian dead lift and lunge progressions), bilateral jumping exercises (double-legged jump progression), and core stability and trunk strengthening exercises (prone trunk stability and lateral trunk flexion progressions) with the use of tools such as Traband, Busobal, balance board) during eight weeks, each week for two sessions (each session approximately 60 minutes). The base movement is first done alone and then becomes more difficult by the addition of a single visual or cognitive task.
Category
Rehabilitation
3
Description
Control group: The control group is without any training intervention and they will just do their usual exercise program.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran Novin Physiotherapy Clinic
Full name of responsible person
Mehdi Amini
Street address
No. 350, Taleghani St., in front of Kayhani School., Nemat Abad
City
Tehran
Province
Tehran
Postal code
1375744513
Phone
+98 21 5583 6241
Email
irannovinclinic@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kharazmi University
Full name of responsible person
Amir Letafatkar
Street address
Mirdamad, Sout Razan Street, Hesari Street, Keshvari Sport complex
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
Kharazmi 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
Kharazmi University
Full name of responsible person
Hossein Tajdini
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Sports Science
Street address
Center for Human Movement Sciences Kharazmi University, Keshvari Sport complex, South Razan Street, Mirdamad
City
Tehran
Province
Tehran
Postal code
158754398
Phone
+98 21 8832 9220
Email
h.tajdini@khu.acc.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Hossein Tajdini
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Sports Science
Street address
Center for Human Movement Sciences Kharazmi University, Keshvari Sport complex, South Razan Street, Mirdamad
City
Tehran
Province
Tehran
Postal code
158754398
Phone
+98 21 8832 9220
Email
h.tajdini@khu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kharazmi University
Full name of responsible person
Hossein Tajdini
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Sports Science
Street address
Center for Human Movement Sciences Kharazmi University, Keshvari Sport complex, South Razan Street, Mirdamad
City
Tehran
Province
Tehran
Postal code
158754398
Phone
+98 21 8832 9220
Email
h.tajdini@khu.ac.ir
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
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