History
# Registration date Revision Id
2 2024-09-07, 1403/06/17 313716
1 2023-06-15, 1402/03/25 268087
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  • Protocol summary

    Clinical trial in phase 2 on 56 volunteers with control and intervention groups with parallel groups, single-blind, randomization by random block method with block sizes of 6 and 9 and with allocation ratio of 1:1
    Clinical trial in phase 2 on 81 volunteers with control and intervention groups with parallel groups, single-blind, randomization by simple randomization method
    کارآزمایی بالینی در فاز 2 بر روی 56 داوطلب دارای گروه کنترل و مداخله با گروههای موازی، یکسو کور، تصادفی سازی به روش بلوک های تصادفی با اندازه بلوک های 6 و 9 تایی و با نسبت تخصیص 1:1
    کارآزمایی بالینی در فاز 2 بر روی 81 داوطلب دارای گروه کنترل و مداخله با گروههای موازی، یکسو کور، تصادفی سازی ساده
    This study will be done in the physiotherapy clinic of Mashhad medical university. Participants will complete pediatrics constipation and incontinence questionnaire and quality of life questionnaires and the number of bowel incontinence per week. Then the patients will be randomized into two intervention and control groups. The control group receive , two biofeedback sessions a week for 6 weeks , and the intervention group receive , two biofeedback and tecar therapy sessions a week for 6 weeks. This study will have a 6-week follow-up.
    This study will be done in the physiotherapy clinic of Mashhad University Rehabilitation Center. The participants will complete the questionnaire of constipation and incontinence and children's quality of life and the frequency of incontinence per week , then the patients will be randomly divided into three intervention groups . Control group: routine medical care including diet and lifestyle modification and laxative consumption Intervention group 1: biofeedback therapy , 2 sessions a week Intervention group 2, biofeedback therapy along with tecar therapy ,2 sessions a week This study will have a 6-week intervention time and 6 weeks follow-up.
    این طرح در کلینیک فیزیوتراپی مرکز توانبخشی دانشگاه مشهد انجام خواهد شد. شرکت کنندگان، پرسشنامه یبوست و بی اختیاری و کیفیت زندگی اطفال را تکمیل خواهند کرد و تعداد دفعات دفع بی اختیار در هفته ثبت خواهد شد، سپس بیماران بصورت تصادفی در دو گروه مداخله و کنترل قرار می گیرند. در گروه کنترل به مدت 6 هفته و در هر هفته 2 جلسه بیوفیدبک انجام خواهد شد و در گروه مداخله بیوفیدبک تراپی به همراه تکارتراپی به مدت 6 هفته و در هر هفته 2 جلسه انجام خواهد شد. این مطالعه دارای 6 هفته فالوآپ خواهد بود.
    این طرح در کلینیک فیزیوتراپی مرکز توانبخشی دانشگاه مشهد انجام خواهد شد. شرکت کنندگان، پرسشنامه یبوست و بی اختیاری و کیفیت زندگی اطفال را تکمیل خواهند کرد و تعداد دفعات دفع بی اختیار در هفته ثبت خواهد شد، سپس بیماران بصورت تصادفی در سه گروه مداخله1 و 2 و کنترل قرار می گیرند. در گروه کنترل به مدت 6 هفته مراقبتهای معمول پزشکی شامل رژیم غذایی و اصلاح سبک زندگی و مصرف ملین در حد نیاز انجام خواهد شد . در گروه مداخله 1 بیوفیدبک تراپی به مدت 6 هفته بصورت 2 جلسه در هر هفته انجام خواهد شد و در گروه مداخله 2 بیوفیدبک تراپی به همراه تکارتراپی به مدت 6 هفته و در هر هفته 2 جلسه انجام خواهد شد. این مطالعه دارای 6 هفته فالوآپ خواهد بود.
    Inclusion criteria: children age range from 4 to 16 years fecal incontinence for 6 months according to the diagnosis of the referring specialist doctor Exclusion criteria: children under 4 years of age over 16 years of age traumatic sphincter injury with/or following surgery anorectal and anatomical abnormalities of the excretory system with/or digestive system and sexual disorders psychological and psychiatric disorders comprehension problems and children who are unable to cooperate with a physiotherapist for any reason Spine with/or nerve diseases that lead to fecal incontinence patients with sensory disorders in the anus and perineum
    Inclusion criteria: children age range from 4 to 16 years fecal incontinence for 6 months according to the diagnosis of the referring specialist doctor Exclusion criteria: traumatic sphincter injury with/or following surgery anorectal and anatomical abnormalities of the excretory system with/or digestive system and sexual disorders psychological and psychiatric disorders comprehension problems and children who are unable to cooperate with a physiotherapist for any reason Spine with/or nerve diseases that lead to fecal incontinence patients with sensory disorders in the anus and perineum
    معیارهای ورود به مطالعه: محدوده سنی کودکان 4 تا 16 سال، بی اختیاری مدفوع به مدت 6 ماه طبق تشخیص پزشک متخصص ارجاع دهنده معیارهای خروج از مطالعه : کودکان کمتر از 4 سال، سن بالای 16 سال، آسیب اسفنکتر تروماتیک و یا به دنبال جراحی، ناهنجاری آنورکتال و آناتومیکی دستگاه دفع و یا دستگاه گوارش و اختلالات جنسی، اختلالات روانشناختی و روانپزشکی، مشکلات درک و فهم و کودکانی که به هردلیل قادر به همکاری با فیزیوتراپیست نباشند، بیماریهای ستون فقرات و اعصاب که منجر به بی اختیاری مدفوع شود، بیماران مبتلا به اختلالات حسی در ناحیه مقعد و پرینه
    معیارهای ورود به مطالعه: محدوده سنی کودکان 4 تا 16 سال، بی اختیاری مدفوع به مدت 6 ماه طبق تشخیص پزشک متخصص ارجاع دهنده معیارهای خروج از مطالعه : آسیب اسفنکتر تروماتیک و یا به دنبال جراحی، ناهنجاری آنورکتال و آناتومیکی دستگاه دفع و یا دستگاه گوارش و اختلالات جنسی، اختلالات روانشناختی و روانپزشکی، مشکلات درک و فهم و کودکانی که به هردلیل قادر به همکاری با فیزیوتراپیست نباشند، بیماریهای ستون فقرات و اعصاب که منجر به بی اختیاری مدفوع شود، بیماران مبتلا به اختلالات حسی در ناحیه مقعد و پرینه
    Control group: biofeedback therapy alone Intervention group: biofeedback with tecar therapy.
    Control group: routine medical care Intervention group 1: biofeedback therapy alone Intervention group2: biofeedback with tecar therapy.
    گروه کنترل: بیوفیدبک به تنهایی گروه مداخله: بیوفیدبک به همراه تکارتراپی
    گروه کنترل: مراقبت معمول پزشکی گروه مداخله 1: بیوفیدبک به تنهایی گروه مداخله 2: بیوفیدبک به همراه تکارتراپی
  • General information

    56
    81
    empty
    At the beginning of the study, the researchers decided to add the usual medical treatment group, so the randomization was changed to three groups, including two physiotherapy intervention groups and one usual medical intervention group.
    empty
    با شروع مطالعه محققین تصمیم گرفتند گروه درمان معمول پزشکی را هم اضافه کنند لذا تصادفی سازی به سه گروه شامل دو گروه مداخله فیزیوتراپی و یک گروه مداخله معمول پزشکی تغییر کردو
    Randomization will be done by random block method with block sizes of 6 and 9 and will be assigned to two groups with 1:1 allocation ratio.
    Randomization will be done by simple randomization method with table of random numbers assigned to three groups.
    تصادفی سازی به روش بلوک های تصادفی با اندازه بلوک های 6 و 9 تایی و با نسبت تخصیص 1:1 به دو گروه تخصیص داده خواهد شد.
    تصادفی سازی به روش تصادفی سازی ساده از طریق جدول اعداد تصادفی به سه گروه تخصیص داده خواهد شد.
  • Intervention groups

    #1
    Intervention group: biofeedback along with thecar therapy
    Intervention group 1: biofeedback therapy
    گروه مداخله: بیوفیدبک به همراه تکارتراپی
    گروه مداخله 1 : بیوفیدبک تراپی
    #2
    empty
    Rehabilitation
    empty
    Intervention group 2: biofeedback along with tecar therapy
    empty
    گروه مداخله2: بیوفیدبک به همراه تکارتراپی
    #3
    empty
    Treatment - Other
    empty
    Control group: routine medical care
    empty
    گروه کنترل: مراقبتهای معمول پزشکی
  • Recruitment centers

    #1
    Name of recruitment center - English: Physiotherapy Clinic, Comprehensive Rehabilitation Center, Faculty of Paramedical Sciences and Rehab
    Name of recruitment center - Persian: کلینیک فیزیوتراپی مرکز جامع توانبخشی دانشکده علوم پیراپزشکی و توانبخشی مشهد
    Full name of responsible person - English: Fariba Ghaderi
    Full name of responsible person - Persian: فریبا قادری
    Street address - English: Daneshgah Ave, Tabriz University of Medical Sciences, Rehabilitation Faculty
    Street address - Persian: دانشگاه علوم پزشکی تبریز - دانشکده توانبخشی
    City - English: Tabriz
    City - Persian: Tabriz
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5167654455
    Phone: +98 912 565 4971
    Fax:
    Email: ghaderimailbox@gmail.com
    Web page address:
    Name of recruitment center - English: Physiotherapy Clinic, Comprehensive Rehabilitation Center, Faculty of Paramedical Sciences and Rehab
    Name of recruitment center - Persian: کلینیک فیزیوتراپی، مرکز جامع توانبخشی، دانشکده علوم پیراپزشکی و توانبخشی مشهد
    Full name of responsible person - English: Fariba Ghaderi
    Full name of responsible person - Persian: فریبا قادری
    Street address - English: Daneshgah Ave, Tabriz University of Medical Sciences, Rehabilitation Faculty
    Street address - Persian: دانشگاه علوم پزشکی تبریز، دانشکده توانبخشی
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5167654455
    Phone: +98 912 565 4971
    Fax:
    Email: ghaderimailbox@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: Fariba Ghaderi
    Full name of responsible person - Persian: فریبا قادری
    Street address - English: Daneshgah Ave, Tabriz University of Medical Sciences, Rehabilitation Faculty
    Street address - Persian: دانشگاه علوم پزشکی تبریز- دانشکده توانبخشی
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5167654455
    Phone: +98 912 565 4971
    Fax:
    Email: ghaderimailbox@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Fariba Ghaderi
    Full name of responsible person - Persian: فریبا قادری
    Street address - English: Daneshgah Ave, Tabriz University of Medical Sciences, Rehabilitation Faculty
    Street address - Persian: دانشگاه علوم پزشکی تبریز، دانشکده توانبخشی
    City - English: Tabriz
    City - Persian: تبریز
    Province: East Azarbaijan
    Country: Iran (Islamic Republic of)
    Postal code: 5167654455
    Phone: +98 912 565 4971
    Fax:
    Email: ghaderimailbox@gmail.com
    Web page address:

Protocol summary

Study aim
In this randomized clinical trial, the effects of tecar therapy with biofeedback in comparison with biofeedback alone on the treatment of fecal incontinence in children (4-16 years) will be investigated.
Design
Clinical trial in phase 2 on 81 volunteers with control and intervention groups with parallel groups, single-blind, randomization by simple randomization method
Settings and conduct
This study will be done in the physiotherapy clinic of Mashhad University Rehabilitation Center. The participants will complete the questionnaire of constipation and incontinence and children's quality of life and the frequency of incontinence per week , then the patients will be randomly divided into three intervention groups . Control group: routine medical care including diet and lifestyle modification and laxative consumption Intervention group 1: biofeedback therapy , 2 sessions a week Intervention group 2, biofeedback therapy along with tecar therapy ,2 sessions a week This study will have a 6-week intervention time and 6 weeks follow-up.
Participants/Inclusion and exclusion criteria
Inclusion criteria: children age range from 4 to 16 years fecal incontinence for 6 months according to the diagnosis of the referring specialist doctor Exclusion criteria: traumatic sphincter injury with/or following surgery anorectal and anatomical abnormalities of the excretory system with/or digestive system and sexual disorders psychological and psychiatric disorders comprehension problems and children who are unable to cooperate with a physiotherapist for any reason Spine with/or nerve diseases that lead to fecal incontinence patients with sensory disorders in the anus and perineum
Intervention groups
Control group: routine medical care Intervention group 1: biofeedback therapy alone Intervention group2: biofeedback with tecar therapy.
Main outcome variables
The number of bowel incontinence per week

General information

Reason for update
At the beginning of the study, the researchers decided to add the usual medical treatment group, so the randomization was changed to three groups, including two physiotherapy intervention groups and one usual medical intervention group.
Acronym
IRCT registration information
IRCT registration number: IRCT20140811018760N9
Registration date: 2023-06-15, 1402/03/25
Registration timing: prospective

Last update: 2024-09-08, 1403/06/18
Update count: 1
Registration date
2023-06-15, 1402/03/25
Registrant information
Name
Fariba Ghaderi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1333 4647
Email address
ghaderif@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-05, 1402/04/14
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of tecar therapy with biofeedback in comparison with biofeedback alone on the treatment of fecal incontinence in children (4-16 years): a randomized clinical trial
Public title
The effects of tecar therapy with biofeedback on the treatment of fecal incontinence in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age range of children is 4 to 16 years Fecal incontinence for 6 months according to the diagnosis of the referring specialist
Exclusion criteria:
Children under 4 years old and over 16 years old Traumatic sphincter injury or following surgery Anorectal and anatomical abnormality of the excretory system or digestive system and sexual disorders Psychological and psychiatric disorders Understanding problems and children who are not able to cooperate with the physiotherapist for any reason. Diseases of the spine or nerves that lead to fecal incontinence Patients with sensory disorders in the anus and perineum
Age
From 4 years old to 16 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 81
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by simple randomization method with table of random numbers assigned to three groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
To hide the allocation of the type of intervention received, it will be written on a piece of paper and placed inside sealed envelopes, consecutively numbered. The envelopes will be opened in the order in which the participants enter the study and the type of group of people will be determined. Due to the nature of the treatment, it is not possible to blind the patient and the researcher, so only the evaluator will be blind to the grouping.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Daneshgah Ave, Tabriz University of Medical Sciences, Rehabilitation Faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5167654455
Approval date
2023-05-28, 1402/03/07
Ethics committee reference number
IR.TBZMED.REC.1402.195

Health conditions studied

1

Description of health condition studied
Children fecal incontinence
ICD-10 code
F98.1
ICD-10 code description
Fecal incontinence

Primary outcomes

1

Description
The number of bowel incontinence per week
Timepoint
6 weeks of treatment period, 6 weeks of follow-up
Method of measurement
Report of the patient or the child's parents

2

Description
Severity of fecal incontinence
Timepoint
6 weeks of treatment period, 6 weeks of follow-up
Method of measurement
Rintala questionnaire

3

Description
Quality of Life
Timepoint
6 weeks of treatment period, 6 weeks of follow-up
Method of measurement
Pediatrics Quality of life questionnaire for fecal incontinent

4

Description
Severity of constipation
Timepoint
6 weeks of treatment period, 6 weeks of follow-up
Method of measurement
Pediatrics constipation questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: biofeedback therapy
Category
Rehabilitation

2

Description
Intervention group 2: biofeedback along with tecar therapy
Category
Rehabilitation

3

Description
Control group: routine medical care
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy Clinic, Comprehensive Rehabilitation Center, Faculty of Paramedical Sciences and Rehab
Full name of responsible person
Fariba Ghaderi
Street address
Daneshgah Ave, Tabriz University of Medical Sciences, Rehabilitation Faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5167654455
Phone
+98 912 565 4971
Email
ghaderimailbox@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Street address
Daneshgah Ave, Tabriz University of Medical Sciences, Rehabilitation Faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5167654455
Phone
+98 912 565 4971
Email
ghaderimailbox@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Position
Professor, PhD of physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tabriz University of Medical Sciences ,Rehabilitation faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 413339771
Fax
Email
ghaderimailbox@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Position
Professor, PhD of physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tabriz University of Medical Sciences ,Rehabilitation faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5167654455
Phone
+98 413339771
Fax
Email
ghaderimailbox@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Ghaderi
Position
Professor, PhD of physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tabriz University of Medical Sciences ,Rehabilitation faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5167654455
Phone
+98 413339771
Fax
Email
ghaderimailbox@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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