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  • Protocol summary

    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
    Comparison of the effects of Virtual reality and conventional training on functional ability and neurocognitive function in athletes with Functional Ankle Instability
    مقایسه اثرات برنامه های درمانی واقعیت مجازی با تمرینات درمانی مرسوم بر توانایی عملکردی و عملکرد عصبی شناختی ورزشکاران مبتلا به بی ثباتی عملکردی مچ پا
    مقایسه اثرات تمرینات واقعیت مجازی با تمرینات درمانی مرسوم بر توانایی عملکردی و عملکرد عصبی شناختی ورزشکاران مبتلا به بی ثباتی عملکردی مچ پا
    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.
    This is a Matched Randomized Clinical Trial Study
    در این مطالعه مداخله ای، کارآزمایی بالینی شاهددار جور شده و یک سویه کور، 40 مرد ورزشکار با بی ثباتی عملکردی یک طرفه مچ پا که به لحاظ سن، سطح فعالیت ورزشی، اندام غالب، قد و وزن جور شده اند به طور تصادفی در گروه آزمون یا کنترل قرار خواهند گرفت. نمونه گیری به روش ساده در دسترس از اعضای سوپرلیگ بسکتبال کرج خواهد بود.
    این یک مطالعه کارآزمایی بالینی تصادفی همسان سازی شده است
    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.
    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.
    مداخله شامل یک برنامه درمانی 4 هفته ای است.گروه کنترل، تمرینات مرسوم و افراد در گروه آزمون تمرین با تخته تعادل Wii fit plus را اجرا می کنند. آزمون های عملکردی شامل star excursion balance test و آزمون های, figure-of-8 hop side hop و single hop می باشند. عملکرد عصبی شناختی که شامل زمان عکس العمل ساده و انتخابی و تعداد خطا می باشد نیز با Deary-Liewald reaction task (DLRT) بررسی می شود. تمامی ارزیابی ها قبل، بلافاصله بعد از اتمام مداخله و یک ماه پس از اتمام مداخله اجرا می شوند. تمام تمرینات و ارزیابی ها در مجموعه ورزشی انقلاب کرج اجرا می شود.
    مداخله شامل یک برنامه درمانی 4 هفته ای است.گروه کنترل، تمرینات مرسوم و افراد در گروه آزمون بازی Wii fit plus را اجرا می کنند. آزمون های عملکردی شامل star excursion balance test و آزمون های side hop, 8-hop و single hop می باشند. عملکرد عصبی شناختی که شامل زمان عکس العمل ساده و انتخابی و تعداد خطا می باشد نیز با Deary-Liewald reaction task (DLRT) بررسی می شود. احساس بی ثباتی سابجکتیو با پرسشنامه CAIT بررسی می شود. تمامی ارزیابی ها قبل، بلافاصله بعد از اتمام مداخله و یک ماه پس از اتمام مداخله اجرا می شوند. تمام تمرینات و ارزیابی ها در مجموعه ورزشی انقلاب کرج اجرا می شود.
    -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.
    Cumberland Ankle Instability Tool score lower than 24, not participating in other rehabilitation exercise programs
    -بی ثباتی عملکردی یکطرفه مچ پا -انجام هفتگی حداقل 5 روز ورزش بسکتبال در هفته و حداقل 5 سال حضور در مسابقات لیگ بسکتبال -نداشتن سابقه شکستگی، دررفتگی و وجود ناهنجاری ساختاری در اندام تحتانی -عدم گزارش آسیب مچ پا در طی 3 ماه اخیر -عدم احساس هرگونه درد و ناراحتی در بدن -عدم مصرف دارو های مسکن، آرامبخش و الکل از 48 ساعت قبل از آزمون -نداشتن سابقه ضربه به سر
    نمره کمتر از 24 در پرسشنامه CAIT، عدم شرکت در سایر برنامه های درمانی
    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.
    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.
    مداخله شامل یک برنامه درمانی 4 هفته ای است. گروه کنترل، تمرینات مرسوم شامل انجام حرکات پلنتارفلکشن، دورسی فلکشن، ایورژن و اینورژن با تراباند و تمرین با تخته تعادل را اجرا می کنند. افراد در گروه آزمون تمرین با تخته تعادل Wii fit plus را اجرا می کنند. برای افزایش تعادل، بازی های Soccer heading ، Ski slalom، Tight rope walk، Table tilt و برای تقویت عضلانی، بازی های Single leg extension، Sideways leg lift، Single leg twist، Rowing squat اجرا می شوند.
    دوازده جلسه تمرینی (سه روز در هفته) در هر دو گروه برگزار می شود. در گروه آزمون، ورزشکاران بازی های Wii Fit Plus را انجام می دهند و در گروه کنترل، ورزشکاران تمرینات مرسوم را انجام می دهند.
    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
    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
    زمان عکس العمل عصبی شناختی تعداد خطا در آزمون عصبی شناختی فاصله قابل دسترس در آزمون عملکردی SEBT فاصله پرش در آزمون single hop زمان صرف شده برای انجام آزمون های figure-of-8 hop و side hop
    زمان عکس العمل عصبی شناختی تعداد خطا در آزمون عصبی شناختی فاصله لمس شده در آزمون عملکردی SEBT فاصله پرش در آزمون single hop زمان صرف شده برای انجام آزمون های figure-of-8 hop و side hop نمره پرسشنامه CAIT
  • General information

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    2017-05-22, 1396/03/01
    2018-05-10, 1397/02/20
    2017-08-20, 1396/05/29
    2019-03-20, 1397/12/29
    2017-08-23, 1396/06/01
    2018-05-22, 1397/03/01
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    2019-06-22, 1398/04/01
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    2019-07-24, 1398/05/02
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    complete the study
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    تکمیل مطالعه
    Comparison of the Effect of Virtual Reality training with conventional treatment in athletes with Functional Ankle Instability
    Comparison of the Effect of Virtual Reality training and conventional training in athletes with Functional Ankle Instability
    Effects of Virtual reality training programs compared to conventional treatment on functional ability and neurocognitive function in athletes with Functional Ankle Instability
    Comparison of the Effects of Virtual reality and conventional training on functional ability and neurocognitive function in athletes with Functional Ankle Instability
    مقایسه اثرات برنامه های درمانی واقعیت مجازی با تمرینات درمانی مرسوم بر توانایی عملکردی و عملکرد عصبی شناختی ورزشکاران مبتلا به بی ثباتی عملکردی مچ پا
    مقایسه اثرات تمرینات واقعیت مجازی با تمرینات درمانی مرسوم بر توانایی عملکردی و عملکرد عصبی شناختی ورزشکاران مبتلا به بی ثباتی عملکردی مچ پا
    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.
    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
    معیارهای انتخاب: 1-ورزشکاران مرد با سن بین 25-18 سال
    2-بی ثباتی عملکردی یکطرفه مچ پا( در صورت درگیر بودن هر دو اندام وارد مطالعه نمی شوند) با بروز حداقل یک پیچ خوردگی در یک سال اخیر و احساس خالی شدن مکرر
    3-عدم وجود بی ثباتی مکانیکی در مچ پای گرفتار با انجام آزمون دراور قدامی و جابجایی تالار
    4-انجام هفتگی حداقل 5 روز ورزش بسکتبال در هفته و حداقل 5 سال حضور در مسابقات لیگ بسکتبال
    5-نداشتن سابقه شکستگی، دررفتگی و وجود ناهنجاری ساختاری (شامل اختلاف طول واضح اندام های تحتانی،زانوی پرانتزی، ضربدری یا متمایل به عقب، افزایش یا کاهش قوس داخلی پا، چرخش رو به داخل یا خارج پنجه پا، چرخش یا لغزش استخوان کشکک، کانترکچرهای مفصلی، انحراف پاشنه پا و بدشکلی های انگشتان پا) در اندام تحتانی
    6-نداشتن سابقه سرگیجه و غش
    7-نداشتن سابقه فراموشی بیمارگونه (با استفاده از پرسشنامه سطح سلامت ذهن)
    8-عدم گزارش آسیب مچ پا در طی 3 ماه اخیر
    9-عدم وجود درد یا التهاب مفصل مچ پا
    10-نداشتن سابقه ضربه به ستون فقرات
    11-نداشتن سابقه کمر درد شدید در 6 ماه گذشته
    12-نداشتن سابقه احساس بی حسی یا سوزن سوزن شدن در اندام تحتانی
    13-عدم احساس هرگونه درد و ناراحتی در بدن
    14-نداشتن سابقه درد و تورم قرینه و دو ره ای در مفاصل
    15-عدم مصرف دارو های مسکن، آرامبخش و الکل از 48 ساعت قبل از آزمون
    16-نداشتن سابقه ضربه به سر
    ورزشکاران مرد 25-19 سال
    بی ثباتی عملکردی یکطرفه مچ پا و تکرار بیش از یکبار یا احساس خالی شدن مکرر در یک سال اخیر
    عدم وجود بی ثباتی مکانیکی در مچ پای گرفتار با انجام آزمون دراور قدامی و جابجایی تالار
    عدم گزارش آسیب مچ پا در طی 3 ماه اخیر
    5-نداشتن سابقه جراحی مچ پا، نداشتن اختلالات وستیبولار و تنفسی، عدم نقص شناختی (نمره 23 یا کمتر در پرسشنامه سطح سلامت ذهن)، نداشتن دیابت و سابقه آسیب اندام تحتانی و آسیب کمر
    نمره پایین تر از 24 در پرسشنامه CAIT
    عدم شرکت در سایر برنامه های درمانی
    1. Expression of any pain and disability.
    2. Non-tendency of the subject to continue the test.
    Report any pain
    Reluctant to continue the tests
    Use any medication with possible effects on neurocognitive function or functional ability
    1-ابراز هرگونه درد و ناتوانی
    2-عدم تمایل آزمودنی به ادامه آزمون
    1-ابراز هرگونه درد
    2-عدم تمایل آزمودنی به ادامه آزمون
    مصرف هر گونه دارویی که بر روی عملکرد عصبی شناختی و توانایی عملکردی اثر گذار باشد
    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.
    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.
    ابتدا ورزشکاران مبتلا به بی ثباتی عملکردی مچ پای دارای معیارهای ورود انتخاب می شوند، هر ورزشکاری که انتخاب می شود به لحاظ قد، وزن، اندام تحتانی غالب و طول دوره فعالیت در رشته بسکتبال با ورزشکار دیگر جور شده و دو ورزشکار انتخاب شده به صورت تصادفی در گروه آزمون یا کنترل قرار می گیرند.
    در طراحی جفت های همسان، ورزشکاران از نظر سن، قد، وزن، طول دوره فعالیت بدنی و اندام تحتانی غالب با هم جفت شدند و سپس به طور تصادفی با استفاده از نرم افزار Random Allocation Software در دو گروه آزمون و کنترل قرار گرفتند.
    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.
    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
    به افراد شرکت کننده توضیح داده می شود که دو مدل درمان در دوگروه اجرا شده و به صورت تصادفی در یکی از گروه ها قرار داده می شوند. اما از اینکه کدام نوع درمان در گروه آزمون یا کنترل اجرا می شود، اطلاعی ندارند
    کلیه آزمونها توسط فیزیوتراپیستی اجرا می شود که نسبت به تعیین گروه و نوع درمان دریافتی ورزشکارانی که توسط فیزیوتراپ دوم انجام می شود، کور است.
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  • Health conditions studied

    #1
    functional ankle instability
    Functional ankle instability
  • Primary outcomes

    #1
    neurocognitive reaction time
    Neurocognitive reaction time
    Before intervention, Immediately after the end of the intervention , A month after the end of the intervention
    Before the intervention, Immediately after the end of the intervention, A month after the end of the intervention
    #2
    Before intervention, Immediately after the end of the intervention , A month after the end of the intervention
    Before the intervention, Immediately after the end of the intervention, A month after the end of the intervention
    #3
    Reachable distance in SEBT
    Reach distance in SEBT
    فاصله قابل دسترس در آزمون عملکردی SEBT
    فاصله لمس شده در آزمون عملکردی SEBT
    Before intervention, Immediately after the end of the intervention , A month after the end of the intervention
    Before the intervention, Immediately after the end of the intervention, A month after the end of the intervention
    #4
    Before intervention, Immediately after the end of the intervention , A month after the end of the intervention
    Before the intervention, Immediately after the end of the intervention, A month after the end of the intervention
    #5
    The time taken to perform the figure-of-8 hop and side hop tests
    The elapsed time to perform the 8-hop and side hop tests
    زمان صرف شده برای انجام آزمون figure-of-8 hop و side hop
    زمان صرف شده برای انجام آزمون 8-hop و side hop
    Before intervention, Immediately after the end of the intervention , A month after the end of the intervention
    Before the intervention, Immediately after the end of the intervention, A month after the end of the intervention
    #6
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    Subjective-sense of instability
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    احساس بی ثباتی سابجکتیو
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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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    قبل از مداخله، بلافاصله بعد از خاتمه مداخله و یک ماه بعد از خاتمه مداخله
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    Cumberland Ankle Instability Tool score (CAIT)
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    نمره پرسشنامه CAIT
  • Intervention groups

    #1
    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.
    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.
    گروه مداخله: افراد در گروه آزمون تمرین با تخته تعادل Wii fit plus را اجرا می کنند. بازی های تعادلی Soccer heading، Ski slalom، Tight rope walk، Table tilt و بازی های قدرتی Single leg extension، Sideways leg lift، Single leg twist، Rowing squat اجرا می شوند.
    ورزشکاران در گروه آزمون بازی Wii fit plus شامل بازی های تعادلی (Soccer heading، Ski slalom، Tight rope walk، Table tilt) و بازی های قدرتی( Single leg extension، Sideways leg lift، Single leg twist، Rowing squat) را اجرا می کنند. در بازی های تمرینی تعادل، ورزشکار روی تخته تعادل Wii ایستاده و با تغییر وزن خود در طول بازی ها، تعادل خود را حفظ می کند. در بازی های قدرتی، ورزشکار روی تخته می ایستد و در هر بازی در حین حرکات خاص، او بایستی حرکات نقطه ثقل را محدود کند تا امتیاز بیشتری کسب کند.
    #2
    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.
    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).
    گروه کنترل: گروه کنترل، تمرینات مرسوم شامل انجام حرکات پلنتارفلکشن، دورسی فلکشن، ایورژن و اینورژن با تراباند و تمرین با تخته تعادل را اجرا می کنند. تمرین با تراباند به صورت سه نوبت 10 تایی در هر جلسه برای هر حرکت بوده و با تراباندهای قرمز رنگ، سبز، آبی و مشکی به ترتیب در هفته اول، دوم،سوم و چهارم اجرا می شود. برای ثابت بودن میزان مقاومت تراباند طی انجام حرکات مچ پا، 70 درصد طول پا به عنوان طول تراباند برای هر فرد در نظر گرفته می شود. برای تمرین تعادل، فرد بر روی تخته تعادل می ایستد در هفته اول لبه قدامی تخته را به زمین نزدیک می کند طوریکه با زمین برخورد نکند و سپس لبه خلفی را به زمین نزدیک میکند. در هفته دوم لبه چپ و راست به زمین نزدیک می شود و در دو هفته آخر حرکات دایره ای شکل اجرا می شود. 15 ثانیه حرکات را انجام می دهند، 10 ثانیه استراحت می کنند و این روال را 10 مرتبه تکرار می کنند.
    در گروه کنترل، ورزشکاران تمرینات مرسوم شامل انجام حرکات پلنتارفلکشن، دورسی فلکشن، ایورژن و اینورژن با تراباند و تمرین با تخته تعادل را اجرا می کنند. تمرین با ترا باند در سه نوبت با ده تکرار برای هر حرکت انجام می شود و به ترتیب در هفته های اول، دوم، سوم و چهارم و به ترتیب با رنگ های قرمز، سبز، آبی و مشکی اجرا می شود. برای تعیین مقاومت ترا باند در حین حرکات مچ پا، 70٪ از طول پا برای هر یک از ورزشکاران به عنوان طول ترا باند در نظر گرفته می شود. ورزشکاران روی تخته تعادل می ایستد و در هفته اول لبه قدامی تخته را به زمین نزدیک می کند طوریکه با زمین برخورد نکند و سپس لبه خلفی را به زمین نزدیک میکند. در هفته دوم لبه چپ و راست به زمین نزدیک می شود و در دو هفته آخر حرکات دایره ای شکل اجرا می شود. (حرکت را به مدت 15 ثانیه ادامه می دهند ؛ 10 ثانیه استراحت می کنند ؛ 10 بار این روند را تکرار می کنند).
  • Recruitment centers

    #1
    Name of recruitment center - English: Enqelab sports complex
    Name of recruitment center - Persian: مجموعه ورزشی انقلاب
    Full name of responsible person - English: ِDr.Mohammad-Reza Hadian Rasanani
    Full name of responsible person - Persian: دکتر محمدرضا هادیان رسنانی
    Street address - English: Neshat Sports HallSports Complex, Enqelab sports complex,karaj
    Street address - Persian: کرج، مجموعه ورزشی انقلاب، سالن ورزشی نشاط
    City - English: karaj
    City - Persian: کرج
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 3183755694
    Phone: +98 26 3351 9765
    Fax:
    Email: rafoolin2007@gmail.com
    Web page address:
    Name of recruitment center - English: Enqelab Sports Complex
    Name of recruitment center - Persian: مجموعه ورزشی انقلاب
    Full name of responsible person - English: ِDr.Mohammad-Reza Hadian Rasanani
    Full name of responsible person - Persian: دکتر محمدرضا هادیان رسنانی
    Street address - English: Neshat Sports HallSports Complex, Enqelab Sports Complex,Karaj
    Street address - Persian: کرج، مجموعه ورزشی انقلاب، سالن ورزشی نشاط
    City - English: karaj
    City - Persian: کرج
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 3183755694
    Phone: +98 26 3351 9765
    Fax:
    Email: rafoolin2007@gmail.com
    Web page address:
  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. AMIRALI SOHRABPOR
    Full name of responsible person - Persian: دکتر امیرعلی سهراب پور
    Street address - English: KESHAVARZ BULUV. GHODS CROSS
    Street address - Persian: بلوار کشاورز-تقاطع قدس
    City - English: TEHRAN
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1417653761
    Phone: +98 21 6649 2271
    Fax:
    Email: tums_edu@tums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Amirali Sohrabpor
    Full name of responsible person - Persian: دکتر امیرعلی سهراب پور
    Street address - English: Keshavarz Buluv. Ghods Cross
    Street address - Persian: بلوار کشاورز-تقاطع قدس
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1417653761
    Phone: +98 21 6649 2271
    Fax:
    Email: tums_edu@tums.ac.ir
    Web page address:
  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr.Mohammad-Reza Hadian Rasanani
    Full name of responsible person - Persian: دکتر محمدرضا هادیان رسنانی
    Position - English: Professor, Ph.D
    Position - Persian: استاد تمام، دکترای تخصصی
    Latest degree: phd
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Enghelab Avenue, Next to Safialishah
    Street address - Persian: تهران، جنب صفی علیشاه
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 11489651111
    Phone: +98 21 7753 3939
    Mobile: +98 910 929 4639
    Fax:
    Email: hadianrasan@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr.Mohammad-Reza Hadian Rasanani
    Full name of responsible person - Persian: دکتر محمدرضا هادیان رسنانی
    Position - English: Professor, Ph.D.
    Position - Persian: استاد تمام، دکترای تخصصی
    Latest degree: phd
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Enghelab Avenue, Next to Safialishah
    Street address - Persian: تهران، جنب صفی علیشاه
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 11489651111
    Phone: +98 21 7753 3939
    Mobile: +98 910 929 4639
    Fax:
    Email: hadianrasan@gmail.com
    Web page address:
  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Niloofar Mohammadi
    Full name of responsible person - Persian: نیلوفر محمدی
    Position - English: PhD candidate
    Position - Persian: دانشجوی دکترای تخصصی
    Latest degree: master
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Enghelab Avenue, next to Safialishah
    Street address - Persian: تهران، خ انقلاب، جنب صفیعلیشاه
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 65111-11489
    Phone: +98 26 3351 9765
    Mobile: +98 912 459 9746
    Fax:
    Email: rafoolin2007@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Niloofar Mohammadi
    Full name of responsible person - Persian: نیلوفر محمدی
    Position - English: Ph.D. candidate
    Position - Persian: دانشجوی دکترای تخصصی
    Latest degree: master
    Area of specialty/work: 68
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Enghelab Avenue, next to Safialishah
    Street address - Persian: تهران، خ انقلاب، جنب صفیعلیشاه
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 65111-11489
    Phone: +98 26 3351 9765
    Mobile: +98 912 459 9746
    Fax:
    Email: rafoolin2007@gmail.com
    Web page address:
  • Sharing plan

    empty
    There is no more information
    empty
    اطلاعات بیشتری وجود ندارد

Protocol summary

Study aim
Comparison of the effects of Virtual reality and conventional training on functional ability and neurocognitive function in athletes with Functional Ankle Instability
Design
This is a Matched Randomized Clinical Trial Study
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
Cumberland Ankle Instability Tool score lower than 24, not participating in other rehabilitation exercise programs
Intervention groups
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.
Main outcome variables
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

Reason for update
complete the study
Acronym
IRCT registration information
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
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
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2018-05-10, 1397/02/20
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
2018-05-22, 1397/03/01
Actual recruitment end date
2019-06-22, 1398/04/01
Trial completion date
2019-07-24, 1398/05/02
Scientific title
Comparison of the Effects of Virtual reality and conventional training on functional ability and neurocognitive function in athletes with Functional Ankle Instability
Public title
Comparison of the Effect of Virtual Reality training and conventional training in athletes with Functional Ankle Instability
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 18 years old to 25 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Investigator
Sample size
Target sample size: 40
Actual sample size reached: 54
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Single blinded
Blinding description
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
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of 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 the 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 the 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
Reach distance in SEBT
Timepoint
Before the 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 the 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 elapsed time to perform the 8-hop and side hop tests
Timepoint
Before the 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

6

Description
Subjective-sense of instability
Timepoint
Before the intervention, Immediately after the end of the intervention, A month after the end of the intervention
Method of measurement
Cumberland Ankle Instability Tool score (CAIT)

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Rehabilitation

2

Description
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).
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
Ph.D. 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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