Protocol summary
-
Study aim
-
Investigating the effect of adding dual cognitive and motor tasks on the rehabilitation and preventive output of athletes who are transferred from a controlled rehabilitation environment to an uncontrolled playground environment
-
Design
-
The statistical population of the present study will be male football players aged 18 to 35 years in Mazandaran province who have a history of anterior cruciate ligament injury and rupture. Injury will be diagnosed under the supervision of a sports medicine specialist through MRI images. From the study population, 36 subjects will be selected who will be placed in three groups of 12 people.
-
Settings and conduct
-
The tests and exercises of the present study will be performed at the Academy of Sacrifice Health and Rehabilitation, and the Clinic of the Sports Medicine Board of Mazandaran Province.
-
Participants/Inclusion and exclusion criteria
-
Criteria for entering the research:
1. People with a history of grade 2 anterior cruciate ligament rupture in the past year
2. Soccer athletes
3. Having a BMI between 18 and 24
4. Not participating in lower limb rehabilitation programs in the last 6 months
5. Having a damaged knee joint up to 80 to 90% of the isokinetic strength of a healthy knee
Exclusion variables:
1. History of complex and multi-ligament injuries of the knee joint
2. History of knee joint surgery
3. The presence of any abnormalities of the lower limbs and spine
4. Feeling of pain in the knee joint
5. Feeling of significant instability and relaxation in the knee joint
6. Sensory and neurological problems
-
Intervention groups
-
The first intervention group, neuromuscular exercises
The second intervention group, neuromuscular exercises with dual tasks
Matched control group, custom exercises
-
Main outcome variables
-
muscle strength; neuromuscular and sensorimotor coordination; balance; Specialized functional performance
General information
-
Reason for update
-
Subject: Request for Correction of Randomized and Blinding Information
Dear reviewer,
With greetings and respect, I would like to inform you that I have mistakenly entered the blinding and randomization details and kindly request permission to correct them.
Sincerely,
Masoud barzegar
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20220602055058N1
Registration date:
2022-12-16, 1401/09/25
Registration timing:
retrospective
Last update:
2025-05-21, 1404/02/31
Update count:
1
-
Registration date
-
2022-12-16, 1401/09/25
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2022-03-06, 1400/12/15
-
Expected recruitment end date
-
2022-08-21, 1401/05/30
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
The effect of 8-week of neuromuscular training with and without cognitive dual-task on proprioception, balance, strength and functional performance of athletes with anterior cruciate ligament deficiency
-
Public title
-
The effect of neuromuscular training and cognitive tasks on functional performance of athletes with anterior cruciate ligament injury
-
Purpose
-
Prevention
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
lack of surgery, having 80-90% isokinetic strength of healthy opposite knee, lack of neurovascular problems and pain
Exclusion criteria:
Joint range of motion problems, pain, swelling, major meniscus rupture
-
Age
-
From 18 years old to 35 years old
-
Gender
-
Male
-
Phase
-
N/A
-
Groups that have been masked
-
-
Sample size
-
Target sample size:
39
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Using permuted block randomization (6 blocks with a size of 7), three treatment arms will be independently allocated to participants in a 1:1:1 ratio (after initial screening). The random sequence list will be generated by computer (Pocock SJ. Clinical Trials: A Practical Approach. Wiley; 1983) and the website https://www.randomizer.org. This process will be overseen by a blinded assessor to ensure allocation concealment.
-
Blinding (investigator's opinion)
-
Single blinded
-
Blinding description
-
The outcome assessor will be blinded to group allocation. Participants will not be blinded to the study or their assigned group; however, they will be blinded to the specific intervention they receive (an unavoidable risk of bias exists in this study, as neither the intervention administrators nor the patients can be fully blinded to the treatment).
Prior to assessments, the outcome assessor will receive standardized training on variable evaluation protocols to prevent any discussion or exchange of information between the assessor and participants during the trial.
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2022-02-20, 1400/12/01
-
Ethics committee reference number
-
IR.SSRI.REC.1400.1340
Health conditions studied
1
-
Description of health condition studied
-
knee injury
-
ICD-10 code
-
-
ICD-10 code description
-
Primary outcomes
1
-
Description
-
1. Neuromuscular exercises with dual cognitive tasks2. Neuromuscular exercises without dual cognitive tasks1. Deep sense2. Equilibrium3. Power4. Performance
-
Timepoint
-
Winter 1400 to Summer 1401
-
Method of measurement
-
1. Consent form and personal information2. Digital scale for measuring weight3. Tape meter for measuring height4. Isokinetic device for measuring muscle strength5. Lower limb function test (LESS and Hopping tests)6. Goniometer to measure joint angle in depth sense test (position sense) in closed chain7. Digital camera to record video images in frontal and sagittal motion screens8. AutoCAD software for measuring detailed angle9. Quinoa software for outputting kinematic data10. Adhesive tape for dynamic balance test Y (Y)
Intervention groups
1
-
Description
-
Intervention group: First - neuromuscular exercises. Second - neuromuscular exercises with dual tasks. Third-control
-
Category
-
Rehabilitation
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Iranian academic center for education culture and research
-
Proportion provided by this source
-
80
-
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
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
Yes - There is 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
-
Yes - There is 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
-
training
-
When the data will become available and for how long
-
one year
-
To whom data/document is available
-
barzegar
-
Under which criteria data/document could be used
-
progression
-
From where data/document is obtainable
-
ever
-
What processes are involved for a request to access data/document
-
total
-
Comments
-