The effect of walking with reverse heel shoes concomitant with routine physiotherapy program on pain, range of motion, stride length, walking speed and disability in patients with knee osteoartritis
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Protocol summary
The aim of this study is to consider the effect of walking with reverse heel shoes concomitant with routine physiotherapy program on some of the knee osteoarthritis symptoms including pain intensity , disability , knee joint range of motion , stride length and walking speed in patients with osteoarthritis . Inclusion criteria : The patients with knee osteoarthritis with intensity of 2 or 3 degree in Kellgren and Lawrence scale ; the age of patients is 40 - 65 years old ; The most pain intensity that patient suffered in the last week is at least 30 of 100 on Visual Analog Scale . Exclusion criteria : Bone Mass Intensity is more than 30 kg/m2 ; The patient involve in systemic arthritis . The accessible population include all patients in Tehran city that refer to central farhangian clinic for knee osteoarthritis physiotherapy treatment . Sampling size is at least 30 subjects and sampling is non-probability (convenient sampling) and randomize them into two intervention and control group; both of them will be treated by routine physiotherapy program for 10 sessions ,but intervention group walk also with reverse heel shoes for 15 minutes two times in a session ,before and after physiotherapy . Then will be measured all of outcomes including pain, disability, range of motion, stride length and walking speed at the beginning of intervention and at the end and following 20 days after the last session too.
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The aim of this study is to consider the effect of walking with reverse heel shoes concomitant with routine physiotherapy program on some of the knee osteoarthritis symptoms including pain intensity , disability , knee joint range of motion , stride length and walking speed in patients with osteoarthritis . Inclusion criteria : The patients with knee osteoarthritis with intensity of 2 or 3 degree in Kellgren and Lawrence scale ; the age of patients is 40 - 65 years old ; The most pain intensity that patient suffered in the last week is at least 30 of 100 on Visual Analog Scale . Exclusion criteria : Bone Mass Intensity is more than 30 kg/m2 ; The patient involve in systemic arthritis . The accessible population include all patients in Tehran city that refer to central farhangian clinic for knee osteoarthritis physiotherapy treatment . Sampling size is at least 30 subjects and sampling is non-probability (convenient sampling) and randomize them into two intervention and control group; both of them will be treated by routine physiotherapy program for 10 sessions ,but intervention group walk also with reverse heel shoes for 15 minutes two times in a session ,before and after physiotherapy . Then will be measured all of outcomes including pain, disability, range of motion, stride length and walking speed at the beginning of intervention and at the end and following 20 days after the last session too.
هدف از این مطالعه بررسی تاثیر راه رفتن با کفش پاشنه معکوس همراه با درمان رایج فیزیوتراپی بر روی بعضی از علائم ارتروز زانو شامل شدت درد ، ناتوانی ، دامنه حرکتی مفصل زانو ، اندازه طول گام و سرعت راه رفتن در بیماران مبتلا به ارتروز زانو می باشد.
معیارهای ورود به مطالعه : افراد مبتلا به ارتروز زانو که شدت ارتروز زانوی انها برابر 2 یا 3 در مقیاس کلگرن و لورنس باشد؛ سن بیماران بین 40 تا 65 سال باشد . بیشترین شدت درد بیماران باید حداقل 30 از 100 در مقیاس دیداری درد ( VAS ) باشد . معیارهای خروج از مطالعه : افراد چاقی که شاخص توده بدنی انها بیشتر از (kg/m2) 30 باشد؛ بیمار مبتلا به ارتریت سیستمیک باشد.
جمعیت مورد مطالعه شامل بیماران شهر تهران که به درمانگاه فرهنگیان مرکزی جهت انجام فیزیوتراپی زانو مراجعه کرده اند می باشد. حجم نمونه حداقل 30 نفر است و نمونه گیری بصورت غیر احتمالی (نمونه های در دسترس) بوده و بصورت تصادفی به دو گروه 15 نفری مداخله و کنترل تقسیم می شوند.
هر دو گروه مداخله و کنترل تحت ده جلسه فیزیوتراپی رایج قرار می گیرند ولی گروه مداخله علاوه بر آن در هر جلسه دو مرتبه بمدت 15 دقیقه قبل و بعد از انجام فیزیوتراپی با کفش پاشنه معکوس پیاده روی می کنند و پیامدهای اولیه که شامل شدت درد ، ناتوانی ، دامنه حرکتی ، طول گام و سرعت راه رفتن می باشند در ابتدا و انتهای مداخله و بیست روز بعد از خاتمه مداخله اندازه گیری می شوند
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هدف از این مطالعه بررسی تاثیر راه رفتن با کفش پاشنه معکوس همراه با درمان رایج فیزیوتراپی بر روی بعضی از علائم ارتروز زانو شامل شدت درد ، ناتوانی ، دامنه حرکتی مفصل زانو ، اندازه طول گام و سرعت راه رفتن در بیماران مبتلا به ارتروز زانو می باشد. معیارهای ورود به مطالعه : افراد مبتلا به ارتروز زانو که شدت ارتروز زانوی انها برابر 2 یا 3 در مقیاس کلگرن و لورنس باشد؛ سن بیماران بین 40 تا 65 سال باشد . بیشترین شدت درد بیماران باید حداقل 30 از 100 در مقیاس دیداری درد ( VAS ) باشد . معیارهای خروج از مطالعه : افراد چاقی که شاخص توده بدنی انها بیشتر از (kg/m2) 30 باشد؛ بیمار مبتلا به ارتریت سیستمیک باشد. جمعیت مورد مطالعه شامل بیماران شهر تهران که به درمانگاه فرهنگیان مرکزی جهت انجام فیزیوتراپی زانو مراجعه کرده اند می باشد. حجم نمونه حداقل 30 نفر است و نمونه گیری بصورت غیر احتمالی (نمونه های در دسترس) بوده و بصورت تصادفی به دو گروه 15 نفری مداخله و کنترل تقسیم می شوند. هر دو گروه مداخله و کنترل تحت ده جلسه فیزیوتراپی رایج قرار می گیرند ولی گروه مداخله علاوه بر آن در هر جلسه دو مرتبه بمدت 15 دقیقه قبل و بعد از انجام فیزیوتراپی با کفش پاشنه معکوس پیاده روی می کنند و پیامدهای اولیه که شامل شدت درد ، ناتوانی ، دامنه حرکتی ، طول گام و سرعت راه رفتن می باشند در ابتدا و انتهای مداخله و بیست روز بعد از خاتمه مداخله اندازه گیری می شوند
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The aim of this study is to consider the effect of walking with reverse heel shoes concomitant with routine physiotherapy program on some of the knee osteoarthritis symptoms including pain intensity, disability, knee joint range of motion, stride length and walking speed in patients with osteoarthritis
The aim of this study is to consider the effect of walking with reverse heel shoes concomitant with routine physiotherapy program on some of the knee osteoarthritis symptoms including pain intensity, disability, knee joint range of motion, stride length and walking speed in patients with osteoarthritis
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هدف از این مطالعه بررسی تاثیر راه رفتن با کفش پاشنه معکوس همراه با درمان رایج فیزیوتراپی بر روی بعضی از علائم ارتروز زانو شامل شدت درد ، ناتوانی ، دامنه حرکتی مفصل زانو ، اندازه طول گام و سرعت راه رفتن در بیماران مبتلا به ارتروز زانو می باشد
هدف از این مطالعه بررسی تاثیر راه رفتن با کفش پاشنه معکوس همراه با درمان رایج فیزیوتراپی بر روی بعضی از علائم ارتروز زانو شامل شدت درد ، ناتوانی ، دامنه حرکتی مفصل زانو ، اندازه طول گام و سرعت راه رفتن در بیماران مبتلا به ارتروز زانو می باشد
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Randomized clinical trial with control group, community based and practical, with parallel groups, no blinded, on 30 patients, randomization was performed by even-odd digits.
Randomized clinical trial with control group, community based and practical, with parallel groups, no blinded, on 30 patients, randomization was performed by even-odd digits.
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کارآزمایی بالینی دارای گروه کنترل، مبتنی بر جامعه و عمل گرا، با گروه های موازی، بدون کورسازی، تصادفی شده، بر روی 30 بیمار ، برای تصادفی سازی از اعداد زوج و فرد استفاده شد
کارآزمایی بالینی دارای گروه کنترل، مبتنی بر جامعه و عمل گرا، با گروه های موازی، بدون کورسازی، تصادفی شده، بر روی 30 بیمار ، برای تصادفی سازی از اعداد زوج و فرد استفاده شد
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The study was performed at central Farhangian clinic in Tehran. Sampling was non-probability (convenient sampling) and patients were randomly allocated in two intervention and control groups (each groups included 15 patients). After interventions; pain, disability, range of motion, stride length and walking speed were measured at the beginning and at the end of the interventions and following 20 days after the last session too. Blinding was not performed in this study.
The study was performed at central Farhangian clinic in Tehran. Sampling was non-probability (convenient sampling) and patients were randomly allocated in two intervention and control groups (each groups included 15 patients). After interventions; pain, disability, range of motion, stride length and walking speed were measured at the beginning and at the end of the interventions and following 20 days after the last session too. Blinding was not performed in this study.
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مطالعه در درمانگاه فرهنگیان مرکزی تهران انجام شد. نمونه گیری بصورت غیر احتمالی (نمونه های در دسترس) بود و بیماران بصورت تصادفی به دو گروه 15 نفری مداخله و کنترل تقسیم شدند. بعد از انجام مداخلات شدت درد ، ناتوانی ، دامنه حرکتی ، طول گام و سرعت راه رفتن در ابتدا و انتهای مداخله و بیست روز بعد از خاتمه مداخله اندازه گیری شدند. در این مطالعه کورسازی انجام نشد.
مطالعه در درمانگاه فرهنگیان مرکزی تهران انجام شد. نمونه گیری بصورت غیر احتمالی (نمونه های در دسترس) بود و بیماران بصورت تصادفی به دو گروه 15 نفری مداخله و کنترل تقسیم شدند. بعد از انجام مداخلات شدت درد ، ناتوانی ، دامنه حرکتی ، طول گام و سرعت راه رفتن در ابتدا و انتهای مداخله و بیست روز بعد از خاتمه مداخله اندازه گیری شدند. در این مطالعه کورسازی انجام نشد.
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Inclusion criteria : The patients with knee osteoarthritis with intensity of 2 or 3 degree in Kellgren and Lawrence scale ; the age of patients is 40 - 65 years old; The most pain intensity that patient suffered in the last week is at least 30 of 100 on Visual Analog Scale. Non inclusion criteria: Bone Mass Intensity is more than 30 kg/m2 ; suffering from systemic arthritis.
Inclusion criteria : The patients with knee osteoarthritis with intensity of 2 or 3 degree in Kellgren and Lawrence scale ; the age of patients is 40 - 65 years old; The most pain intensity that patient suffered in the last week is at least 30 of 100 on Visual Analog Scale. Non inclusion criteria: Bone Mass Intensity is more than 30 kg/m2 ; suffering from systemic arthritis.
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معیارهای ورود به مطالعه: افراد مبتلا به ارتروز زانو که شدت ارتروز زانوی انها برابر 2 یا 3 در مقیاس کلگرن و لورنس باشد؛ سن بیماران بین 40 تا 65 سال باشد؛ بیشترین شدت درد بیماران باید حداقل 30 از 100 در مقیاس دیداری درد ( VAS ) باشد. معیارهای عدم ورود به مطالعه: افراد چاقی که شاخص توده بدنی انها بیشتر از (kg/m2) 30 باشد؛ بیمار مبتلا به ارتریت سیستمیک باشد.
معیارهای ورود به مطالعه: افراد مبتلا به ارتروز زانو که شدت ارتروز زانوی انها برابر 2 یا 3 در مقیاس کلگرن و لورنس باشد؛ سن بیماران بین 40 تا 65 سال باشد؛ بیشترین شدت درد بیماران باید حداقل 30 از 100 در مقیاس دیداری درد ( VAS ) باشد. معیارهای عدم ورود به مطالعه: افراد چاقی که شاخص توده بدنی انها بیشتر از (kg/m2) 30 باشد؛ بیمار مبتلا به ارتریت سیستمیک باشد.
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Both groups will be treated by routine physiotherapy program for 10 sessions including: continuous ultrasound for 6 minutes on anterior and posterior of knee, then conventional TENS with hot pack around knee for 20 minutes and several type of exercises, but intervention group walk also with reverse heel shoes for 15 minutes two times in a session ,before and after physiotherapy.
Both groups will be treated by routine physiotherapy program for 10 sessions including: continuous ultrasound for 6 minutes on anterior and posterior of knee, then conventional TENS with hot pack around knee for 20 minutes and several type of exercises, but intervention group walk also with reverse heel shoes for 15 minutes two times in a session ,before and after physiotherapy.
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هر دو گروه مداخله و کنترل تحت ده جلسه فیزیوتراپی رایج شامل 6 دقیقه اولتراسوند ممتد در قدام و خلف زانو، سپس 20 دقیقه جریان تنس نرمال به همراه هات پک اطراف زانو و چند نوع مشخص ورزش درمانی قرار می گیرند ولی گروه مداخله علاوه بر آن در هر جلسه دو مرتبه بمدت 15 دقیقه قبل و بعد از انجام فیزیوتراپی با کفش پاشنه معکوس پیاده روی می کنند.
هر دو گروه مداخله و کنترل تحت ده جلسه فیزیوتراپی رایج شامل 6 دقیقه اولتراسوند ممتد در قدام و خلف زانو، سپس 20 دقیقه جریان تنس نرمال به همراه هات پک اطراف زانو و چند نوع مشخص ورزش درمانی قرار می گیرند ولی گروه مداخله علاوه بر آن در هر جلسه دو مرتبه بمدت 15 دقیقه قبل و بعد از انجام فیزیوتراپی با کفش پاشنه معکوس پیاده روی می کنند.
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pain intensity , disability , knee joint range of motion , stride length and walking speed
pain intensity , disability , knee joint range of motion , stride length and walking speed
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شدت درد ، ناتوانی ، دامنه حرکتی مفصل زانو ، اندازه طول گام و سرعت راه رفتن
شدت درد ، ناتوانی ، دامنه حرکتی مفصل زانو ، اندازه طول گام و سرعت راه رفتن
General information
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30
30
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2017-12-01, 1396/09/10
2017-12-01 00:00:00
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2018-04-09, 1397/01/20
2018-04-09 00:00:00
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2018-09-11, 1397/06/20
2018-09-11 00:00:00
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Trial completion
Trial completion
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پایان یافتن کارازمایی
پایان یافتن کارازمایی
the effect of walking with reverse heel shoes on improving knee osteoarthritis symptoms
The effect of walking with reverse heel shoes on improving knee osteoarthritis symptoms
theThe effect of walking with reverse heel shoes on improving knee osteoarthritis symptoms
the effect of walking with reverse heel shoes concomitant with routine physiotherapy program on pain , range of motion , stride length ,walking speed and disability in patients with knee osteoartritis
The effect of walking with reverse heel shoes concomitant with routine physiotherapy program on pain, range of motion, stride length, walking speed and disability in patients with knee osteoartritis
theThe effect of walking with reverse heel shoes concomitant with routine physiotherapy program on pain, range of motion, stride length,walking speed and disability in patients with knee osteoartritis
بررسی تاثیر افزودن راه رفتن با کفش پاشنه معکوس به برنامه فیزیوتراپی رایج،بر متغیرهای شدت درد،دامنه حرکتی،طول گام،سرعت راه رفتن و ناتوانی در افراد مبتلا به استئوارتریت
بررسی تاثیر افزودن راه رفتن با کفش پاشنه معکوس به برنامه فیزیوتراپی رایج بر متغیرهای شدت درد، دامنه حرکتی، طول گام، سرعت راه رفتن و ناتوانی در افراد مبتلا به استئوارتریت
بررسی تاثیر افزودن راه رفتن با کفش پاشنه معکوس به برنامه فیزیوتراپی رایج،بر متغیرهای شدت درد،دامنه حرکتی،طول گام،سرعت راه رفتن و ناتوانی در افراد مبتلا به استئوارتریت
Age of patient between 40-65 years old
Knee DJD intensity is 2-3 degree on Kellgren & Lawrence
Symptoms beginning is gradual
Not being occur after trauma or accident or fracture
The most pain intensity that patient suffered in the last week would be at least 30 of 100 on Visual Analog Scale
Age of patient between 40-65 years old Knee DJD intensity is 2-3 degree on Kellgren & Lawrence Symptoms beginning is gradual Not being occur after trauma or accident or fracture The most pain intensity that patient suffered in the last week would be at least 30 of 100 on Visual Analog Scale
محدوده سنی بین 40 تا 65
شدت ارتروز زانو درجه 2--3 در مقیاس کلگرن و لورانس
شروع علائم تدریجی باشد
بدنبال ضربه ,تصادف و یا شکستگی ایجاد نشده باشد
بیشترین شدت دردی که بیمار طی هفته گذشته تحمل کرده بالاتر از 30 از 100 در مقیاس دیداری درد ( VAS ) باشد
محدوده سنی بین 40 تا 65 شدت ارتروز زانو درجه 2--3 در مقیاس کلگرن و لورانس شروع علائم تدریجی باشد بدنبال ضربه ,تصادف و یا شکستگی ایجاد نشده باشد بیشترین شدت دردی که بیمار طی هفته گذشته تحمل کرده بالاتر از 30 از 100 در مقیاس دیداری درد ( VAS ) باشد
Joint injection therapy in recent 3 months
Knee joint ligament injury
Body Mass Index is more than 30 kg/m2
Systemic arthritis
Using cane or crutch or walker
Joint injection therapy in recent 3 months Knee joint ligament injury Body Mass Index is more than 30 kg/m2 Systemic arthritis Using cane or crutch or walker
انجام تزریق داخل مفصلی در سه ماهه اخیر
افرادی که سابقه اسیب لیگامانهای زانو دارند
شاخص توده بدنی بیشتر از 30 (kg/m2)
ابتلا به ارتریت سیستمیک
استفاده از وسایل کمکی مثل عصا حین راه رفتن
انجام تزریق داخل مفصلی در سه ماهه اخیر افرادی که سابقه اسیب لیگامانهای زانو دارند شاخص توده بدنی بیشتر از 30 (kg/m2) ابتلا به ارتریت سیستمیک استفاده از وسایل کمکی مثل عصا حین راه رفتن
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First patient and as the same manner the rest of patients who had odd numbers were placed in control group and second patient and the rest of patients with even numbers in intervention group
First patient and as the same manner the rest of patients who had odd numbers were placed in control group and second patient and the rest of patients with even numbers in intervention group
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اولین بیمار و بقیه بیماران با شماره فرد در گروه کنترل و دومین بیمار و بقیه بیماران با شماره زوج در گروه مداخله قرار داده شدند
اولین بیمار و بقیه بیماران با شماره فرد در گروه کنترل و دومین بیمار و بقیه بیماران با شماره زوج در گروه مداخله قرار داده شدند
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at least 30 subjects
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at least 30 subjects
حداقل 30 نفر
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حداقل 30 نفر
Recruitment centers
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Name of recruitment center - English: Central Farhangian Clinic
Name of recruitment center - Persian: درمانگاه فرهنگیان مرکزی
Full name of responsible person - English: Mohsen Shams
Full name of responsible person - Persian: محسن شمس
Street address - English: Next to Fayazbakhsh Bus Terminal , Imam Khomeini Square
Street address - Persian: میدان امام خمینی ، جنب ترمینال اتوبوسرانی فیاض بخش
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
Name of recruitment center - English: Central Farhangian Clinic
Name of recruitment center - Persian: درمانگاه فرهنگیان مرکزی
Full name of responsible person - English: Mohsen Shams
Full name of responsible person - Persian: محسن شمس
Street address - English: Next to Fayazbakhsh Bus Terminal , Imam Khomeini Square
Street address - Persian: میدان امام خمینی ، جنب ترمینال اتوبوسرانی فیاض بخش
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1114655111
Phone:
Fax:
Email: dfm@tehranedu.org
Web page address:
Name of recruitment center - English: Central Farhangian Clinic Name of recruitment center - Persian: درمانگاه فرهنگیان مرکزی Full name of responsible person - English: Mohsen Shams Full name of responsible person - Persian: محسن شمس Street address - English: Next to Fayazbakhsh Bus Terminal , Imam Khomeini Square Street address - Persian: میدان امام خمینی ، جنب ترمینال اتوبوسرانی فیاض بخش City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1114655111 Phone: Fax: Email: dfm@tehranedu.org Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Hamidreza Khankeh
Full name of responsible person - Persian: حمید رضا خانکه
Street address - English: Koodakyar Blind Alley, Daneshjoo Boulevard, Evin
Street address - Persian: تهران، اوین ، بلوار دانشجو ، بن بست کودکیار
City - English: Tehran
City - Persian: تهران
Province:
Country: Iran (Islamic Republic of)
Postal code:
Phone:
Fax:
Email:
Web page address:
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: amir masoud arab loodaricheh
Full name of responsible person - Persian: امیر مسعود عرب لودریچه
Street address - English: Koodakyar Blind Alley, Daneshjoo Boulevard, Evin
Street address - Persian: تهران، اوین ، بلوار دانشجو ، بن بست کودکیار
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۹۸۵۷۱۳۸۳۴
Phone: +98 21 2218 0039
Fax:
Email: am.arabloo@uswr.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی Full name of responsible person - English: Hamidreza Khankehamir masoud arab loodaricheh Full name of responsible person - Persian: حمید رضا خانکهامیر مسعود عرب لودریچه Street address - English: Koodakyar Blind Alley, Daneshjoo Boulevard, Evin Street address - Persian: تهران، اوین ، بلوار دانشجو ، بن بست کودکیار City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۹۸۵۷۱۳۸۳۴ Phone: +98 21 2218 0039 Fax: Email: am.arabloo@uswr.ac.ir Web page address:
empty
Public
public
empty
Domestic
domestic
empty
Academic
academic
Person responsible for general inquiries
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Mohsen Shams
Full name of responsible person - Persian: محسن شمس
Position - English: Master Student of Physiotherapy
Position - Persian: دانشجوی کارشناسی ارشد فیزیوتراپی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Koodakyar Blind Alley, Daneshjoo Boulevard, Evin
Street address - Persian: اوین ، بلوار دانشجو ، بن بست کودکیار
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 21 7739 4525
Mobile: +98 935 737 4933
Fax:
Email: mo.shams@uswr.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Mohsen Shams
Full name of responsible person - Persian: محسن شمس
Position - English: PhD candidate of Physiotherapy
Position - Persian: دانشجوی دکتری فیزیوتراپی
Latest degree: master
Area of specialty/work: 68
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Koodakyar Blind Alley, Daneshjoo Boulevard, Evin
Street address - Persian: اوین ، بلوار دانشجو ، بن بست کودکیار
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 21 7739 4525
Mobile: +98 935 737 4933
Fax:
Email: mo.shams@uswr.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی Full name of responsible person - English: Mohsen Shams Full name of responsible person - Persian: محسن شمس Position - English: Master StudentPhD candidate of Physiotherapy Position - Persian: دانشجوی کارشناسی ارشددکتری فیزیوتراپی Latest degree: master Area of specialty/work: 068 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Koodakyar Blind Alley, Daneshjoo Boulevard, Evin Street address - Persian: اوین ، بلوار دانشجو ، بن بست کودکیار City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1985713834 Phone: +98 21 7739 4525 Mobile: +98 935 737 4933 Fax: Email: mo.shams@uswr.ac.ir Web page address:
Person responsible for scientific inquiries
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی وتوانبخشی
Full name of responsible person - English: Mohsen Shams
Full name of responsible person - Persian: محسن شمس
Position - English: Master Student of Physiotherapy
Position - Persian: دانشجوی کارشناسی ارشد فیزیوتراپی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Koodakyar Blind Alley, Daneshjoo Boulevard, Evin
Street address - Persian: اوین ، بلوار دانشجو ، بن بست کودکیار
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 21 7739 4525
Mobile: +98 935 737 4933
Fax:
Email: mo.shams@uswr.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی وتوانبخشی
Full name of responsible person - English: Mohsen Shams
Full name of responsible person - Persian: محسن شمس
Position - English: PhD candidate of Physiotherapy
Position - Persian: دانشجوی دکتری فیزیوتراپی
Latest degree: master
Area of specialty/work: 68
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Koodakyar Blind Alley, Daneshjoo Boulevard, Evin
Street address - Persian: اوین ، بلوار دانشجو ، بن بست کودکیار
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 21 7739 4525
Mobile: +98 935 737 4933
Fax:
Email: mo.shams@uswr.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences Name of organization / entity - Persian: دانشگاه علوم بهزیستی وتوانبخشی Full name of responsible person - English: Mohsen Shams Full name of responsible person - Persian: محسن شمس Position - English: Master StudentPhD candidate of Physiotherapy Position - Persian: دانشجوی کارشناسی ارشددکتری فیزیوتراپی Latest degree: master Area of specialty/work: 068 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Koodakyar Blind Alley, Daneshjoo Boulevard, Evin Street address - Persian: اوین ، بلوار دانشجو ، بن بست کودکیار City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1985713834 Phone: +98 21 7739 4525 Mobile: +98 935 737 4933 Fax: Email: mo.shams@uswr.ac.ir Web page address:
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Mohsen Shams
Full name of responsible person - Persian: محسن شمس
Position - English: Master student of Physiotherapy
Position - Persian: دانشجوی کارشناسی ارشد فیزیوتراپی
Latest degree:
Area of specialty/work: 0
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Koodakyar Blind Alley , Daneshjoo Boulevard , Evin
Street address - Persian: اوین ، بلوار دانشجو ، بن بست کودکیار
City - English: Tehran
City - Persian: تهران
Province:
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 21 7739 4525
Mobile: +98 935 737 4933
Fax:
Email: mo.shams@uswr.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences
Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی
Full name of responsible person - English: Mohsen Shams
Full name of responsible person - Persian: محسن شمس
Position - English: PhD candidate of Physiotherapy
Position - Persian: دانشجوی دکتری فیزیوتراپی
Latest degree: master
Area of specialty/work: 68
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Koodakyar Blind Alley , Daneshjoo Boulevard , Evin
Street address - Persian: اوین ، بلوار دانشجو ، بن بست کودکیار
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1985713834
Phone: +98 21 7739 4525
Mobile: +98 935 737 4933
Fax:
Email: mo.shams@uswr.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: University of Social Welfare and Rehabilitation Sciences Name of organization / entity - Persian: دانشگاه علوم بهزیستی و توانبخشی Full name of responsible person - English: Mohsen Shams Full name of responsible person - Persian: محسن شمس Position - English: Master studentPhD candidate of Physiotherapy Position - Persian: دانشجوی کارشناسی ارشددکتری فیزیوتراپی Latest degree: master Area of specialty/work: 068 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Koodakyar Blind Alley , Daneshjoo Boulevard , Evin Street address - Persian: اوین ، بلوار دانشجو ، بن بست کودکیار City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1985713834 Phone: +98 21 7739 4525 Mobile: +98 935 737 4933 Fax: Email: mo.shams@uswr.ac.ir Web page address:
Sharing plan
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
undecided
empty
there is no more information
there is no more information
empty
اطلاعات بیشتری وجود ندارد
اطلاعات بیشتری وجود ندارد
Protocol summary
Study aim
The aim of this study is to consider the effect of walking with reverse heel shoes concomitant with routine physiotherapy program on some of the knee osteoarthritis symptoms including pain intensity, disability, knee joint range of motion, stride length and walking speed in patients with osteoarthritis
Design
Randomized clinical trial with control group, community based and practical, with parallel groups, no blinded, on 30 patients, randomization was performed by even-odd digits.
Settings and conduct
The study was performed at central Farhangian clinic in Tehran. Sampling was non-probability (convenient sampling) and patients were randomly allocated in two intervention and control groups (each groups included 15 patients). After interventions; pain, disability, range of motion, stride length and walking speed were measured at the beginning and at the end of the interventions and following 20 days after the last session too. Blinding was not performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria : The patients with knee osteoarthritis with intensity of 2 or 3 degree in Kellgren and Lawrence scale ; the age of patients is 40 - 65 years old; The most pain intensity that patient suffered in the last week is at least 30 of 100 on Visual Analog Scale. Non inclusion criteria: Bone Mass Intensity is more than 30 kg/m2 ; suffering from systemic arthritis.
Intervention groups
Both groups will be treated by routine physiotherapy program for 10 sessions including: continuous ultrasound for 6 minutes on anterior and posterior of knee, then conventional TENS with hot pack around knee for 20 minutes and several type of exercises, but intervention group walk also with reverse heel shoes for 15 minutes two times in a session ,before and after physiotherapy.
Main outcome variables
pain intensity , disability , knee joint range of motion , stride length and walking speed
General information
Reason for update
Trial completion
Acronym
IRCT registration information
IRCT registration number:IRCT2017071535097N1
Registration date:2017-11-19, 1396/08/28
Registration timing:prospective
Last update:2020-07-23, 1399/05/02
Update count:1
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Mohsen Shams
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7739 2705
Email address
mo.shams@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
personal funding source
Expected recruitment start date
2017-12-01, 1396/09/10
Expected recruitment end date
2018-03-01, 1396/12/10
Actual recruitment start date
2017-12-01, 1396/09/10
Actual recruitment end date
2018-04-09, 1397/01/20
Trial completion date
2018-09-11, 1397/06/20
Scientific title
The effect of walking with reverse heel shoes concomitant with routine physiotherapy program on pain, range of motion, stride length, walking speed and disability in patients with knee osteoartritis
Public title
The effect of walking with reverse heel shoes on improving knee osteoarthritis symptoms
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age of patient between 40-65 years old
Knee DJD intensity is 2-3 degree on Kellgren & Lawrence
Symptoms beginning is gradual
Not being occur after trauma or accident or fracture
The most pain intensity that patient suffered in the last week would be at least 30 of 100 on Visual Analog Scale
Exclusion criteria:
Joint injection therapy in recent 3 months
Knee joint ligament injury
Body Mass Index is more than 30 kg/m2
Systemic arthritis
Using cane or crutch or walker
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
First patient and as the same manner the rest of patients who had odd numbers were placed in control group and second patient and the rest of patients with even numbers in intervention group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Social Welfare and Rehabilitation Sciences
Street address
Koodakyar Blind Alley , Daneshjoo Boulevard , Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2017-10-18, 1396/07/26
Ethics committee reference number
IR.USWR.REC.1396.184
Health conditions studied
1
Description of health condition studied
Osteoartritis
ICD-10 code
M17
ICD-10 code description
Gonarthrosis [arthrosis of knee]
Primary outcomes
1
Description
Pain Intensity
Timepoint
Befor intervention - After end of the intervention - 20 days following end of the intervention
Method of measurement
Visual Analog Scale
2
Description
Rang Of Motion
Timepoint
Befor intervention - After end of intervention - 20 days following end of the intervention
Method of measurement
Goniometer
3
Description
Walking speed
Timepoint
Befor intervention - After end of intervention - 20 days following end of the intervention
Method of measurement
10 meter walk test
4
Description
Stride length
Timepoint
Befor intervention - After end of intervention - 20 days following end of the intervention
Method of measurement
To meter walked 15 stride then division it per 15
5
Description
Disability
Timepoint
Befor intervention - After end of intervention - 20 days following end of the intervention
Method of measurement
Knee injury and Osteoartritis Outcome Score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Walking with reverse heel shoes in 15 minutes for two times in each session during 10 session plus routine physiotherapy including continuous ultrasound (1 MHZ frequency and 1 w/cm2) for 6 minutes then conventional TENS (100 HZ frequency and 50 microsecond so that can be sense with hot pack in anterior and posterior of knee for 20 minutes , resistance exercises for quadriceps , hip abductors and calf leg muscles
Category
Rehabilitation
2
Description
Control group: Routine physiotherapy including continuous ultrasound (1 MHZ frequency and 1 w/cm2) for 6 minutes then conventional TENS (100 HZ frequency and 50 microsecond so that can be sense with hot pack in anterior and posterior of knee for 20 minutes , resistance exercises for quadriceps , hip abductors and calf leg muscles
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Central Farhangian Clinic
Full name of responsible person
Mohsen Shams
Street address
Next to Fayazbakhsh Bus Terminal , Imam Khomeini Square
City
Tehran
Province
Tehran
Postal code
1114655111
Email
dfm@tehranedu.org
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
amir masoud arab loodaricheh
Street address
Koodakyar Blind Alley, Daneshjoo Boulevard, Evin
City
Tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0039
Email
am.arabloo@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation 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
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Mohsen Shams
Position
PhD candidate of Physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Koodakyar Blind Alley, Daneshjoo Boulevard, Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7739 4525
Fax
Email
mo.shams@uswr.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Mohsen Shams
Position
PhD candidate of Physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Koodakyar Blind Alley, Daneshjoo Boulevard, Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7739 4525
Fax
Email
mo.shams@uswr.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Mohsen Shams
Position
PhD candidate of Physiotherapy
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Koodakyar Blind Alley , Daneshjoo Boulevard , Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 7739 4525
Fax
Email
mo.shams@uswr.ac.ir
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