Comparison of the effects of virtual reality-based trainings and conventional trainings on anticipatory and compensatory strategies while ball kicking in soccer-players with chronic ankle instability
comparison of the effect of virtual reality-based training and conventional trainings on anticipatory and compensatory strategies while ball kicking in football-players with chronic ankle instability.
Design
parallel group trial,blinded with design of 56 patients.randomization was done with randomization.com
Settings and conduct
after assessments,each patient will be treated in control or intervention group for 12 sessions.48 hours after last session they will be re-assessed.Assessment will be held in laboratory of rehabilitation faculty.
Third person out of the research will code data in a way that they are unclear.Then they will be handed to analyzer and he/she will analyze data with software, then the former third person will put data in SPSS.
Participants/Inclusion and exclusion criteria
soccer players age between 18-35 with unilateral chronic ankle instability and recurrent ankle sprain with moderate to vigorous physical activity with no history of fracture of surgery in lower limb.
Intervention groups
Intervention group:Balance training and strengthening with Wii fit games:table tilt ,penguin fishing ,soccer heading,tightrope walk,single leg extension and torso twist
Control group:Stretching and ankle musculature strengthening exercises with progressive Neuro-Muscular exercises.
Main outcome variables
reducing feeling of ankle instability,improvement in functional tests,improvement in muscle function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230124057197N1
Registration date:2023-06-30, 1402/04/09
Registration timing:registered_while_recruiting
Last update:2023-06-30, 1402/04/09
Update count:0
Registration date
2023-06-30, 1402/04/09
Registrant information
Name
Rezvane Faghihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4407 6493
Email address
rezvane.fa76@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-25, 1401/12/06
Expected recruitment end date
2023-09-28, 1402/07/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of virtual reality-based trainings and conventional trainings on anticipatory and compensatory strategies while ball kicking in soccer-players with chronic ankle instability
Public title
Virtual Reality in Chronic Ankle Instability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Soccer player with moderate to vigorous physical activity
History of first Unilateral Ankle Sprain incident At least 12Month Before Enrollment(The Last Sprain Should be At least For 3month ago)
Feeling of instability or Recurrent Giving Way in the Past Year
Cumberland Ankle instability Tool Score <=24
No History of Neurological or Psychological Impairments
No History of Surgery or Fracture in Ankle or lower limb
Exclusion criteria:
participants who refuse to participate in trial for any reason
participants who Refuse to Continue Participating Due to Pain or any other Reason
Acute inflammation/Pain
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
the participants are randomly assigned to either the intervention group or the control group with a 1:1 allocation ratio.randomization is performed using a web-based randomization service (WWW.randomization.com). Random allocation is carried out by a third party not involved in the study.details of the allocated groups are written on cards and placed inside sequentially numbered,opaque,sealed envelopes.in this way ,the allocation sequence was concealed from the main researches
Blinding (investigator's opinion)
Single blinded
Blinding description
Third person out of the research will code data in a way that they are unclear.Then they will be handed to analyzer and he/she will analyze data with software, then the former third person will put data in SPSS.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethiques Committees of School of Nursing and Midwifery & Rehabilitation-Tehran University o
Street address
6th floor, Central Building Tehran University of Medical Science, Qods Street Cross Section, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
9128398903
Approval date
2023-01-21, 1401/11/01
Ethics committee reference number
IR.TUMS.FNM.REC.1401.149
Health conditions studied
1
Description of health condition studied
Chronic Ankle Instability
ICD-10 code
M25.373
ICD-10 code description
Other instability, unspecified ankle
Primary outcomes
1
Description
Normalized Integrated Electromyography of Proneus Longous ,soleous,Rectus Femoris,Biceps Femoris,Gluteous Medious of the Injured Leg
Timepoint
Before First Session of Intervention and 24-72 Hours After the Last Session
Method of measurement
DataLOG for Portable Data Acquisition and Monitoring
Secondary outcomes
1
Description
Covered Distance in Y-Balnce Test in Anterior/Posterior-Medial and Posterior-Lateral Directions
Timepoint
Before The First Session of Intervention and 24-72 Hours After the Last Session
Method of measurement
Strip Meter
2
Description
feeling of ankle instability
Timepoint
Before The First Session of Intervention and 24-72 Hours After the Last Session
Method of measurement
Cumberland Ankle Instability Tool
Intervention groups
1
Description
Intervention group:Patients will be treated by Nintendo Wii fit for 12 Sessions(3 sessions,4 weeks) for 1hour.All in all They will Play 6 games which Single leg extension and Torso twist are Categorized in Strengthening Games and table tilt,Soccer heading,Tightrope walk,Penguin fishing are categorized in balance group.Patients move the avatar and gain points with shifting their weight on Wii board.
Category
Treatment - Other
2
Description
Control group: patients will do theraband strengthening exercises,stretching and jumping.they have to perform task while maintaining their balance on different surfaces.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Physical Education and Sport Sciencesوو
Full name of responsible person
Mohammad Karimizade
Street address
between 15th and 16th St., North Kargar st.
City
Tehran
Province
Tehran
Postal code
5664646464
Phone
+98 21 8802 1527
Email
infosport@ut.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotohi
Street address
6th floor., Faculty of Research and Information Technology., Qods St., Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1142324333
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?