Protocol summary
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Study aim
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Comparison of the effects of Virtual reality and conventional training on functional ability and neurocognitive function in athletes with Functional Ankle Instability
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Design
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This is a Matched Randomized Clinical Trial Study
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Settings and conduct
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The intervention consists of a 4-week training program. The control group performs the conventional exercises and subjects in the experimental group perform Wii Fit Plus games. Functional performance tests include the Star Excursion Balance Test (SEBT), 8-hop, side hop, and single hop tests. The neurocognitive function assesses with the Deary-Liewald reaction task (DLRT) including simple and choice reaction times and error rate. To assess subjective-sense of instability, we use CAIT. All assessments have performed before, Immediately after the end of the intervention, and a month after the end of the intervention. All training and assessments run in the Karaj Revolutionary Sports Complex.
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Participants/Inclusion and exclusion criteria
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Cumberland Ankle Instability Tool score lower than 24, not participating in other rehabilitation exercise programs
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Intervention groups
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Twelve training sessions (three days per week) are conducted in both groups. In the experimental group, athletes have performed Wii Fit Plus games and in the control group, athletes have performed the conventional training.
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Main outcome variables
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Neurocognitive reaction time
Number of errors in the neurocognitive test
Reach distance in SEBT
Jump distance in single hop test
The elapsed time in the 8-hop and side hop tests
CAIT score
General information
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Reason for update
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complete the study
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20090301001722N19
Registration date:
2018-05-07, 1397/02/17
Registration timing:
prospective
Last update:
2020-05-11, 1399/02/22
Update count:
1
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Registration date
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2018-05-07, 1397/02/17
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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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Tehran University of Medical Sciences
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Expected recruitment start date
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2018-05-10, 1397/02/20
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Expected recruitment end date
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2019-03-20, 1397/12/29
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Actual recruitment start date
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2018-05-22, 1397/03/01
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Actual recruitment end date
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2019-06-22, 1398/04/01
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Trial completion date
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2019-07-24, 1398/05/02
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Scientific title
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Comparison of the Effects of Virtual reality and conventional training on functional ability and neurocognitive function in athletes with Functional Ankle Instability
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Public title
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Comparison of the Effect of Virtual Reality training and conventional training in athletes with Functional Ankle Instability
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Male athletes are 19-25 years old
They have at least one significant unilateral inversion sprain of either ankle followed by more than one repeated injury or the perception of the ankle “giving-way,” within the last year
No evidence of mechanical instability; that assessed by the anterior drawer and talar tilt tests
No history of ankle injury within the 3 months before participation
No ankle surgery, no vestibular or respiratory disorder, no cognitive deficit (A score of 23 or less in Mini-Mental State Examination), no diabetes or recent lower-limb or low back pathology
A Cumberland Ankle Instability Tool score lower than 24
Not participating in other rehabilitation exercise programs
Exclusion criteria:
Report any pain
Reluctant to continue the tests
Use any medication with possible effects on neurocognitive function or functional ability
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Age
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From 18 years old to 25 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:
40
Actual sample size reached:
54
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In the matched pairs design athletes were pair-matched in terms of age, height, weight, duration of physical activity, and lower-limb dominance and then randomly assigned (block randomization) in two equal experimental and control groups using the Random Allocation Software.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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All tests are conducting by a physiotherapist who is blind to the assignment and type of training of athletes that perform by the second physiotherapist
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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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2017-08-19, 1396/05/28
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Ethics committee reference number
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IR. TUMS. FNM. REC. 1396. 3235
Health conditions studied
1
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Description of health condition studied
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Functional ankle instability
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ICD-10 code
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S93.4
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ICD-10 code description
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Sprain of ankle
Primary outcomes
1
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Description
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Neurocognitive reaction time
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Timepoint
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Before the intervention, Immediately after the end of the intervention, A month after the end of the intervention
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Method of measurement
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Measurement tool: DLRT software, Measurement scale: milliseconds
2
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Description
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Number of errors in neurocognitive test
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Timepoint
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Before the intervention, Immediately after the end of the intervention, A month after the end of the intervention
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Method of measurement
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Measurement tool: DLRT software, Measurement scale: Number
3
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Description
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Reach distance in SEBT
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Timepoint
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Before the intervention, Immediately after the end of the intervention, A month after the end of the intervention
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Method of measurement
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Measurement tool: Meter, Measurement scale: Meter
4
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Description
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Jump distance in single hop test
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Timepoint
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Before the intervention, Immediately after the end of the intervention, A month after the end of the intervention
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Method of measurement
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Measurement tool: Meter, Measurement scale: Meter
5
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Description
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The elapsed time to perform the 8-hop and side hop tests
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Timepoint
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Before the intervention, Immediately after the end of the intervention, A month after the end of the intervention
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Method of measurement
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Measurement tool: Stopwatch, Measurement scale: milliseconds
6
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Description
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Subjective-sense of instability
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Timepoint
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Before the intervention, Immediately after the end of the intervention, A month after the end of the intervention
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Method of measurement
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Cumberland Ankle Instability Tool score (CAIT)
Intervention groups
1
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Description
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In the experimental group, athletes have performed Wii Fit Plus games including balance training games (e.g. Soccer heading, Ski slalom, Tight rope walk, Table tilt), and strengthening exercises (e.g. Single leg extension, Sideways leg lift, Single leg twist, Rowing squat). In balance training games the athlete stands on the Wii balance board and maintains his balance by shifting his weight during the games. In strengthening games, the athlete stands on the board, and in each game during the specific movements, he must limit the gravity point movements to earn more points.
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Category
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Rehabilitation
2
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Description
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In the control group, athletes have performed conventional exercises including plantar flexion, dorsiflexion, inversion, and eversion movements with Thera-Band and exercising with the balance board. Training with Thera-Band is performed 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, 70% of leg length is considered as Thera-Band length, for each athlete. The athletes stand on the balance board and move the front edge against the floor then move the board back, in the first week. During exercise, the board should not touch the floor. In the second week, they move the left and right edges against the floor, and in the last two weeks, circular movements are performed. (they continue the movement for 15 seconds; rest for 10 seconds; repeat this trend 10 times).
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Category
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Rehabilitation
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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Tehran University of Medical Sciences
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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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Undecided - It is not yet known if there will be a plan to make this available
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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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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available