Protocol summary

Study aim
The effect of visual biofeedback on static, dynamic and proprioceotion, balance in military athletes with anterior cruciate ligament injury
Design
Randomized clinical trial with a control group parallel to the size of 30 participants, blinded
Settings and conduct
In this study, the participants were randomly divided into two groups of observation and control (n = 15). The balance of the subjects was evaluated by the Berg Balance Scale. The profound sense of the subjects was recorded using a system of digital photographic, non-reflective markers and analysis with Digimizer software version 5.3.4. In the control group, the exercises were received with visual feedback. At the end of the re-evaluation, the participants were evaluated in terms of balance and proprioceotion. The exercises were done by both groups for 4 weeks and 3 sessions for half an hour each week. The study was performed at the orthopedic clinic of Baqiyatallah hospital.
Participants/Inclusion and exclusion criteria
ACL damage; lack of cognitive impairment; vision and hearing; lack of any muscular and systemic nervous system; limb length difference (more than 1 cm), spastic cerebral palsy; drug addiction or alcohol, and any complications Disturbance of the balance; absence of neurological diseases or uncontrolled seizures before and during the intervention
Intervention groups
Both groups performed equilibrium exercises for 4 weeks and 3 sessions per week for half an hour, except that the experimental group received these exercises with visual feedback
Main outcome variables
Static and dynamic balance; proprioception; Angle reconstruction error

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181010041300N1
Registration date: 2018-12-24, 1397/10/03
Registration timing: retrospective

Last update: 2018-12-24, 1397/10/03
Update count: 0
Registration date
2018-12-24, 1397/10/03
Registrant information
Name
javad naghizad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 1721
Email address
j.naghizad_ot@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
2018-06-23, 1397/04/02
Actual recruitment end date
2018-09-27, 1397/07/05
Trial completion date
2018-09-27, 1397/07/05
Scientific title
The Effects of Visual Feedback on Balance and Proprioception in Military Athletes with Anterior Cruciate Ligament (ACL) Injury
Public title
Effects of Visual Feedback on Balance and Proprioception in Athletes with ACL Injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Had an ACL injury that has been approved by the orthopedic specialist There are no cognitive impairment, visual acuity and hearing loss (wearing glasses and mirrors) No muscular and systemic nervous system impairment (diabetes and rheumatism) No difference in limb length (more than 1 cm) Spastic cerebral palsy Drug addiction or alcohol abuse; and any disorder affecting balance (atrial fibrillation, stroke, etc.) The absence of neurological or uncontrolled seizures before and during the intervention
Exclusion criteria:
Unwillingness to cooperate Missing more than 3 sessions Being admitted to the hospital Perform surgery Fracture
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 24
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals were randomly assigned to either control or intervention group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants had no connection with each other and did not know their role as an intervention or control group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of the University of Medical Sciences
Street address
BaqiatallahUniversity of Medical Sciences. Mullasadra Street,Vanak Square,Tehran
City
tehran
Province
Tehran
Postal code
1435916471
Approval date
2018-03-17, 1396/12/26
Ethics committee reference number
IR.BMSU.REC.1396.521

Health conditions studied

1

Description of health condition studied
Assessment of balance and proprioception in patients with anterior cruciate ligament injury
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Balance Score in the Berg Balance Scale test
Timepoint
Balance assessment before and after the intervention
Method of measurement
Berg Balance Scale

2

Description
The amount of error in the proprioception in the reconstruction of the target angle
Timepoint
Proprioception assessment before and after the intervention
Method of measurement
With a system of digital photographic, non-reflective markers and analysis with Digimizer software, version 5.3.4 was recorded.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Individuals with anterior cruciate ligament injury who received balance exercises with visual feedback for 4 weeks and 3 sessions per week.
Category
Rehabilitation

2

Description
Control group: Individuals with anterior cruciate ligament injury who received balance exercises without vision feedback for 4 weeks and 3 sessions per week.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiatallah hospital
Full name of responsible person
Alireza shamsoddini
Street address
Baqiatallah hospital. Mullasadra Street,Vanak Square,Tehran
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0436
Email
info@baq.ir
Web page address
https://baq.bmsu.ac.ir/Portal/Home/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Aliraza shamsoddini
Street address
Mullasadra Street,Vanak Square,Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
info@bmsu.ac.ir
Web page address
https://www.bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Javad naghizad
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No.10, kavian Ave, Yosef abad Blvd, tehran
City
Tehran
Province
Tehran
Postal code
1431993431
Phone
+98 21 8872 1400
Email
j.naghizad1994@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Aliraza shasoddini
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
BaqiatallahUniversity of Medical Sciences, Mullasadra Street,Vanak Square,Tehran
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8804 0060
Email
alirezaot@bmsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Javad naghizad
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No10. kavian Ave. Yosef abad Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1431993134
Phone
+98 41 4454 2484
Email
j.naghizad1994@gmail.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
security issues
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
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