Protocol summary
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Study aim
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The effect of neuromuscular training with neurocognitive training on selected psychological, functional and biomechanical factors in male athletes with anterior cruciate ligament reconstruction
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Design
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A clinical trial with a control group, with parallel groups, single-blind, randomized, on 45 patients, and Random Allocation Software will be used for randomization.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Psychological, functional and biomechanical factors
General information
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Reason for update
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Trial completion date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20211113053053N1
Registration date:
2021-12-10, 1400/09/19
Registration timing:
registered_while_recruiting
Last update:
2022-04-11, 1401/01/22
Update count:
2
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Registration date
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2021-12-10, 1400/09/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-11-20, 1400/08/29
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Expected recruitment end date
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2022-01-15, 1400/10/25
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Actual recruitment start date
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2021-11-22, 1400/09/01
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Actual recruitment end date
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2022-01-17, 1400/10/27
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Trial completion date
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2022-04-09, 1401/01/20
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Scientific title
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The effect of neuromuscular training with neurocognitive training on selected psychological, functional and biomechanical factors in male athletes with anterior cruciate ligament reconstruction
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Public title
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The effect of neurocognitive training on rehabilitation of male athletes with anterior cruciate ligament reconstruction
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 30 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
45
Actual sample size reached:
45
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Outcome assessor is kept blind. The assessor was blinded to the group allocation.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-06-21, 1400/03/31
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Ethics committee reference number
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IR.SSRC.REC.1400.065
Health conditions studied
1
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Description of health condition studied
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Anterior cruciate ligament reconstruction
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ICD-10 code
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S83.5
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ICD-10 code description
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Sprain of cruciate ligament of knee
Primary outcomes
1
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Description
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Dynamic knee valgus angle during landing
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Timepoint
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Before the intervention and the end of the intervention
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Method of measurement
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Motion analysis system
Secondary outcomes
1
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Description
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Psychological readiness
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Timepoint
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Before the intervention and the end of the intervention
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Method of measurement
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Anterior Cruciate Ligament Return - To - Sport after Injury
2
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Description
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Torque of the lower limb joints during landing
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Timepoint
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Before the intervention and the end of the intervention
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Method of measurement
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Motion analysis system and force plate
3
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Description
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Coordination and Coordination Variability
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Timepoint
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Before the intervention and the end of the intervention
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Method of measurement
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Motion analysis system
Intervention groups
1
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Description
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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).
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
3
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Description
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Control group: The control group is without any training intervention and they will just do their usual exercise program.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kharazmi University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available