History
# Registration date Revision Id
2 2020-05-08, 1399/02/19 133793
1 2018-05-07, 1397/02/17 44617
Changes made to previous revision
This is the first revision

Protocol summary

Study aim
to determine the effects of Virtual reality training programs compared to conventional treatment on functional ability and neurocognitive function in athletes with Functional Ankle Instability
Design
In this Interventional, matched randomized controlled trial and single blinded study, 40 male athletes with unilateral functional ankle instability that matched by age, sports level, limb dominance, height, and weight will randomly be assigned to a test group or a control group. They will be sampled by convenient method from Karaj basketball super league members.
Settings and conduct
The intervention consists of a 4-wk training program. The control group performing the conventinal exercises and subjects in the intervention group practices with Wii Fit Plus balance board. Functional performance tests (FPTs) include the star excursion balance test (SEBT), figure-of-8, side, and single hop tests. Neurocognitive function was assessed with the Deary-Liewald reaction task (DLRT) including simple and choice reaction times and error rate. All assessments are performed before, Immediately after the end of the intervention and a month after the end of the intervention. All training and Assessments are carried out in the Karaj Revolutionary Sports Complex.
Participants/Inclusion and exclusion criteria
-unilateral functional ankle instability - Perform weekly basketball at least 5 days a week and at least 5 years in a basketball league - No history of fracture, dislocation, and structural abnormalities in the lower extremities -not reporting ankle injury in the last 3 months - No feeling of any pain and discomfort in the body. -No drug intake, sedation and alcohol from 48 hours before the test. -No history of head injury.
Intervention groups
The intervention consists of a 4-wk training program. The control group performing the conventinal exercises include plantar flexion, dorsiflexion, inversion, and eversion moves with Thera-Band and exercising with balance board Training. subjects in the intervention group practices with Wii Fit Plus balance board. For exercise that enhances balancing sense, participants headed soccer balls, tightrope walked, table tilted, and slalomed on skis and for muscle strengthening exercise, single leg extensions, sideways leg lifts, single leg twists, and rowing squats were performed.
Main outcome variables
neurocognitive reaction time number of errors in neurocognitive test reachable distance in SEBT jump distance in single hop test the time taken to perform the figure-of-8 hop and side hop tests

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20090301001722N19
Registration date: 2018-05-07, 1397/02/17
Registration timing: na

Last update: 2018-05-07, 1397/02/17
Update count: 1
Registration date
2018-05-07, 1397/02/17
Registrant information
Name
Samira Karimpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 3939
Email address
hadianrs@sina.tums.ac.ir
Recruitment status
Not enough for processing
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-08-20, 1396/05/29
Actual recruitment start date
2017-08-23, 1396/06/01
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Virtual reality training programs compared to conventional treatment on functional ability and neurocognitive function in athletes with Functional Ankle Instability
Public title
Comparison of the Effect of Virtual Reality training with conventional treatment in athletes with Functional Ankle Instability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1.Male athletes aged 18-25 years 2. a minimum of one major unilateral inversion sprain at least one experience of recurrence of ankle sprain or giving-way during the previous year. 3. The absence of mechanical instability in the ankle indicated by anterior drawer and talar tilt tests 4. Perform weekly basketball at least 5 days a week and at least 5 years in a basketball league 5. No history of fracture, dislocation, and structural abnormalities (including the apparent length difference of the lower extremities, genovarum, genovalgum or hyper extension, increase or decrease of the medial arc of the foot, internal or external rotation of toes, rotation or slipping of patella, Articulate contracture, deformity of the heel, and deformity of the toes) in the lower extremities 6. No history of dizziness and fainting 7. No history of amnesia (using mini mental status exam) 8.not reporting ankle injury in the last 3 months 9. Lack of pain or inflammation of the ankle joint 10-No history of vertebral spine injury 11-No history of severe back pain in the last 6 months 12-No history of numbness or tingling in the lower extremity 13. No feeling of any pain and discomfort in the body. 14. Not having history of the sympathetic and double-sided pain and swelling in the joints. 15-No drug intake, sedation and alcohol from 48 hours before the test. 16-No history of head injury.
Exclusion criteria:
1. Expression of any pain and disability. 2. Non-tendency of the subject to continue the test.
Age
From 18 years old to 25 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
At first, athletes with functional ankle instability that have inclusion criteria to be selected. Each selected athlete is matched in terms of height, weight, dominant lower extremity, and duration of the activity in the basketball with another athlete, and the two athletes selected as Randomized in the test or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants will be described that two treatment models are performed in two groups and they are They are randomly assigned to one of the groups but They do not know which type of treatment is being administered in the test or control group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
School of Rehabilitation, Tehran University of Medical Science
Street address
School o fRehabilitation,Piche Shemiran, Enghelab Ave, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
65111-11489
Approval date
2017-08-19, 1396/05/28
Ethics committee reference number
IR. TUMS. FNM. REC. 1396. 3235

Health conditions studied

1

Description of health condition studied
functional ankle instability
ICD-10 code
S93.4
ICD-10 code description
Sprain of ankle

Primary outcomes

1

Description
neurocognitive reaction time
Timepoint
Before intervention, Immediately after the end of the intervention , A month after the end of the intervention
Method of measurement
Measurement tool: DLRT software, Measurement scale: milliseconds

2

Description
Number of errors in neurocognitive test
Timepoint
Before intervention, Immediately after the end of the intervention , A month after the end of the intervention
Method of measurement
Measurement tool: DLRT software, Measurement scale: Number

3

Description
Reachable distance in SEBT
Timepoint
Before intervention, Immediately after the end of the intervention , A month after the end of the intervention
Method of measurement
Measurement tool: Meter, Measurement scale: Meter

4

Description
Jump distance in single hop test
Timepoint
Before intervention, Immediately after the end of the intervention , A month after the end of the intervention
Method of measurement
Measurement tool: Meter, Measurement scale: Meter

5

Description
The time taken to perform the figure-of-8 hop and side hop tests
Timepoint
Before intervention, Immediately after the end of the intervention , A month after the end of the intervention
Method of measurement
Measurement tool: Stopwatch, Measurement scale: milliseconds

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: subjects in the test group practices with Wii Fit Plus balance board.For exercise that enhances balancing sense, participants headed soccer balls, tightrope walked, table tilted, and slalomed on skis and for muscle strengthening exercise, single leg extensions, sideways leg lifts, single leg twists, and rowing squats were performed.
Category
Rehabilitation

2

Description
Control group: The control group performing the conventinal exercises include plantar flexion, dorsiflexion, inversion, and eversion moves with Thera-Band and exercising with balance board Training with Thera-Band is performing in three sets with ten repetitions for each movement and is performed in the first, second, third and fourth weeks, with red, green, blue and black, respectively. To determine Thera-Band resistance during the ankle movements, leg length is considered as Thera-Band length, for each subject. The subject stands on the balance board and move the front edge against the floor in the first week. Then move the board back. During exercise the board shoud not touch the floor. In the second week move the left and right edges against the floor, and in the last two weeks, Circulating movement are performed. Continue the movement for 15 seconds. Rest for 10 second. Repeat this session 10 times.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Enqelab sports complex
Full name of responsible person
ِDr.Mohammad-Reza Hadian Rasanani
Street address
Neshat Sports HallSports Complex, Enqelab sports complex,karaj
City
karaj
Province
Tehran
Postal code
3183755694
Phone
+98 26 3351 9765
Email
rafoolin2007@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. AMIRALI SOHRABPOR
Street address
KESHAVARZ BULUV. GHODS CROSS
City
TEHRAN
Province
Tehran
Postal code
1417653761
Phone
+98 21 6649 2271
Email
tums_edu@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
School of Rehabilitation, Tehran University of Medical Sciences
Full name of responsible person
Niloofar Mohammadi
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Enghelab Avenue, after Pich-E-Shemiran, next to SafiAlishah St.
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 26 3351 9765
Fax
Email
rafoolin2007@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Mohammad-Reza Hadian Rasanani
Position
Professor, Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Enghelab Avenue, Next to Safialishah
City
Tehran
Province
Tehran
Postal code
11489651111
Phone
+98 21 7753 3939
Fax
Email
hadianrasan@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Niloofar Mohammadi
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Enghelab Avenue, next to Safialishah
City
Tehran
Province
Tehran
Postal code
65111-11489
Phone
+98 26 3351 9765
Fax
Email
rafoolin2007@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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