The effect of virtual reality camera-based mirror therapy on upper extremity motor function in patients with hemiplegic cerebral palsy 8 to 12 years: a pilot study
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Protocol summary
A clinical trial with a control group, with parallel groups, one-way blind, evaluator of uninformed allocation, randomized, on 10 patients. Randomized program was used.
A clinical trial with a control group, with parallel groups, one-way blind, evaluator of uninformed allocation, randomized, on 20 patients. Randomized program was used.
A clinical trial with a control group, with parallel groups, one-way blind, evaluator of uninformed allocation, randomized, on 1020 patients. Randomized program was used.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، یک سویه کور ، ارزیاب کننده از تخصیص بی اطلاع است، تصادفی شده، بر روی 10 بیمار. برای تصادفی سازی از برنامه randomize استفاده شد.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، یک سویه کور ، ارزیاب کننده از تخصیص بی اطلاع است، تصادفی شده، بر روی 20 بیمار. برای تصادفی سازی از برنامه randomize استفاده شد.
کارآزمایی بالینی دارای گروه کنترل، با گروه های موازی ، یک سویه کور ، ارزیاب کننده از تخصیص بی اطلاع است، تصادفی شده، بر روی 1020 بیمار. برای تصادفی سازی از برنامه randomize استفاده شد.
General information
10
20
1020
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The study was conducted in a pilot study, due to the situation of the coronavirus in the country and the lack of available samples, the statistics consultant selected the number of 10 people. By increasing the number of clients in the rehabilitation centers, we realized that we could increase the number of samples. With the number of 20 people, we started sampling after consulting and checking with the statistics consultant professor, and supervisors.
The study was conducted in a pilot study, due to the situation of the coronavirus in the country and the lack of available samples, the statistics consultant selected the number of 10 people. By increasing the number of clients in the rehabilitation centers, we realized that we could increase the number of samples. With the number of 20 people, we started sampling after consulting and checking with the statistics consultant professor, and supervisors.
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مطالعه به صورت مقدماتی (pilot) انجام شد که به علت وضعیت کرونا در کشور و کمبود نمونه های در دسترس تعداد 10 نفر توسط استاد مشاور آمار انتخاب شد، در ابتدای نمونه گیری به علت کاهش تعداد بیماران کرونایی و برگشت شرایط سفید کرونایی به کشور و افزایش حضور مراجعین در مراکز توانبخشی، متوجه شدیم میتوانیم تعداد نمونه را افزایش دهیم و با تعداد 20 نفر پس از مشورت و بررسی با استاد مشاور آمار و اساتید راهنما نمونه گیری را آغاز کردیم.
مطالعه به صورت مقدماتی (pilot) انجام شد که به علت وضعیت کرونا در کشور و کمبود نمونه های در دسترس تعداد 10 نفر توسط استاد مشاور آمار انتخاب شد، در ابتدای نمونه گیری به علت کاهش تعداد بیماران کرونایی و برگشت شرایط سفید کرونایی به کشور و افزایش حضور مراجعین در مراکز توانبخشی، متوجه شدیم میتوانیم تعداد نمونه را افزایش دهیم و با تعداد 20 نفر پس از مشورت و بررسی با استاد مشاور آمار و اساتید راهنما نمونه گیری را آغاز کردیم.
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: hamid reza khnkeh
Full name of responsible person - Persian: حمیدرضا خانکه
Street address - English: Kodakyar Ave., Daneshjo Blvd.,Evin
Street address - Persian: تهران، اوین، بلوار دانشجو، بن بست کودکیار، دانشگاه علوم توانبخشی و سلامت اجتماعی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985713871
Phone: +98 21 7173 2000
Fax:
Email: webmaster@uswr.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hamid Reza Khnkeh
Full name of responsible person - Persian: حمیدرضا خانکه
Street address - English: Kodakyar Ave., Daneshjo Blvd.,Evin
Street address - Persian: تهران، اوین، بلوار دانشجو، بن بست کودکیار، دانشگاه علوم توانبخشی و سلامت اجتماعی
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1985713871
Phone: +98 21 7173 2000
Fax:
Email: Webmaster@uswr.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: hamid reza khnkehHamid Reza Khnkeh Full name of responsible person - Persian: حمیدرضا خانکه Street address - English: Kodakyar Ave., Daneshjo Blvd.,Evin Street address - Persian: تهران، اوین، بلوار دانشجو، بن بست کودکیار، دانشگاه علوم توانبخشی و سلامت اجتماعی City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1985713871 Phone: +98 21 7173 2000 Fax: Email: webmasterWebmaster@uswr.ac.ir Web page address:
Protocol summary
Study aim
Assessing the effect of virtual reality camera-based mirror therapy on upper extremity motor function in children with hemiplegic cerebral palsy
Design
A clinical trial with a control group, with parallel groups, one-way blind, evaluator of uninformed allocation, randomized, on 20 patients. Randomized program was used.
Settings and conduct
All clients of rehabilitation centers affiliated with the University of Rehabilitation Sciences and Social welfare, who are eligible to enter the research and express their consent, will participate in the research (in writing).
This study is double-blind; in which the participant and the evaluator were unaware of the allocation of individuals.
Participants/Inclusion and exclusion criteria
Do not use mirror therapy approaches before the intervention; Being at levels I, II, and III of the MACS manual ability classification system; Ability to study at school; Mild spasticity involved in wrist flexor (modified Ashworth scale less than 2); Do not inject Botox or surgery on the upper limb for up to 1 year before the intervention; Occurrence of orthopedic disease or seizures.
Intervention groups
Control group (Common rehabilitation treatment group): Patients receive occupational therapy sessions three times a week for 8 weeks and the duration of each session is 45 minutes.
Intervention group: Mirror Therapy group receives a virtual reality-based camera-based mirror therapy program in addition to conventional treatments.
Main outcome variables
Selective control of the upper extremity scale; gross manual dexterity; the range of motion; the great hand muscles strength; the strength of the delicate muscles of the hand; upper extremity skills quality
General information
Reason for update
The study was conducted in a pilot study, due to the situation of the coronavirus in the country and the lack of available samples, the statistics consultant selected the number of 10 people. By increasing the number of clients in the rehabilitation centers, we realized that we could increase the number of samples. With the number of 20 people, we started sampling after consulting and checking with the statistics consultant professor, and supervisors.
Acronym
IRCT registration information
IRCT registration number:IRCT20211024052860N1
Registration date:2022-04-14, 1401/01/25
Registration timing:registered_while_recruiting
Last update:2022-07-23, 1401/05/01
Update count:1
Registration date
2022-04-14, 1401/01/25
Registrant information
Name
Amir Hossein Nasiri Naeini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8808 8666
Email address
ah.nasiri@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-06-05, 1401/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of virtual reality camera-based mirror therapy on upper extremity motor function in patients with hemiplegic cerebral palsy 8 to 12 years: a pilot study
Public title
The effect of virtual reality camera-based mirror therapy on upper extremity motor function in patients with hemiplegic cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 8 to 12 years
Hemiplegic cerebral palsy, diagnosed by a neurologist
Being at levels I, II and III of the MACS (manual ability classification system)
Ability to study at school
Mild spasticity involved in wrist flexor (modified Ashworth scale less than 2)
Exclusion criteria:
Unwillingness to participate in the study (not completing the consent form)
Use mirror therapy approaches before the intervention
Injection of Botox or surgery on the upper limb for up to 1 year before the intervention
Age
From 8 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Before starting the study, a list of letters A and B is generated using the randomization site, which indicates the assignment of individuals to study groups, and individuals are placed in groups according to the order of entering the research.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluator is unaware of the assignment of individuals to the groups and the participants are divided into two groups of control and intervention by randomized program.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of University of Social Welfare and Rehabilitation Sciences
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2021-10-20, 1400/07/28
Ethics committee reference number
IR.USWR.REC.1400.168
Health conditions studied
1
Description of health condition studied
hemiplegic cerebral palsy
ICD-10 code
G80.2
ICD-10 code description
Spastic hemiplegic cerebral palsy
Primary outcomes
1
Description
Selective Control of the Upper Extremity Scale
Timepoint
The beginning of the intervention, after 8 weeks, the follow-up period after 4 weeks
Method of measurement
Selective Control of the Upper Extremity Scale Test
2
Description
Gross manual dexterity
Timepoint
The beginning of the intervention, after 8 weeks, the follow-up period after 4 weeks
Method of measurement
Box and block test
3
Description
Range of motion
Timepoint
The beginning of the intervention, after 8 weeks, the follow-up period after 4 weeks
Method of measurement
Goniometer
4
Description
Large hand muscles strength
Timepoint
The beginning of the intervention, after 8 weeks, the follow-up period after 4 weeks
Method of measurement
Dynamometer
5
Description
The strength of the delicate muscles of the hand
Timepoint
The beginning of the intervention, after 8 weeks, the follow-up period after 4 weeks
Method of measurement
Pinched gauge
6
Description
Quality of Upper Extremity Skills
Timepoint
The beginning of the intervention, after 8 weeks, the follow-up period after 4 weeks
Method of measurement
Quality of Upper Extremity Skills Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mirror Therapy group will receive a virtual reality-based camera-based mirror therapy program in addition to conventional treatments three sessions per week for 8 weeks. The duration of each session will be 45 minutes, of which 20 minutes belong to the camera-based mirror therapy program based on virtual reality.
Category
Rehabilitation
2
Description
Control group: Common rehabilitation treatment group - Patients in this group will receive occupational therapy sessions three times a week for 8 weeks and the duration of each session will be 45 minutes. Patients in the standard rehabilitation group will perform standard therapy, routine rehabilitation therapy based on neuromuscular facilitation techniques (diagonal patterns), and Bobet neurodevelopmental technique with emphasis on practicing functional tasks as much as possible and fine motor activities. Weightlifting, reflex inhibition patterns, torso rotation, and scapula protrusion will also be used to reduce spasticity, if necessary, during exercise. Nearly 25 percent of the usual rehabilitation treatment time will be spent on compensatory techniques using a healthy limb to perform functional tasks and help the affected limb with a healthy hand during homework.
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamid Reza Khnkeh
Street address
Kodakyar Ave., Daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 7173 2000
Email
Webmaster@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
1
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
Amir Hossein Nasiri Naeini
Position
Masters student of Occupational Therapy
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No. 22, First Floor, Shahid Navarani Blvd., Intersection of DaryaBlvd., Farahzadi Blvd., Sanat Sq., Gharb Town, Tehran,
City
Tehran
Province
Tehran
Postal code
1468973841
Phone
+98 21 8808 8666
Fax
Email
ah.nasiri@uswr.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Amir Hossein Nasiri Naeini
Position
Masters student of Occupational Therapy
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No. 22, First Floor, Shahid Navarani Blvd., Intersection of DaryaBlvd., Farahzadi Blvd., Sanat Sq., Gharb Town, Tehran.
City
Tehran
Province
Tehran
Postal code
1468973841
Phone
+98 21 8808 8666
Fax
Email
ah.nasiri@uswr.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Amir Hossein Nasiri Naeini
Position
Masters student of Occupational Therapy
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
No. 22, First Floor, Shahid Navarani Blvd., Intersection of DaryaBlvd., Farahzadi Blvd., Sanat Sq., Gharb Town, Tehran.
City
Tehran
Province
Tehran
Postal code
1468973841
Phone
+98 21 8808 8666
Fax
Email
ah.nasiri@uswr.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The dissertation is kept in the occupational therapy department of the University of Rehabilitation Sciences and Social Health and the relevant articles are published in the relevant journals.
When the data will become available and for how long
Access period starts 6 months after the publication of the article
To whom data/document is available
All experts who work in this field
Under which criteria data/document could be used
For clinical studies and in treatment
From where data/document is obtainable
Refer to the Department of Occupational Therapy at the University of Rehabilitation Sciences and Social Health
What processes are involved for a request to access data/document
Obtaining permission from the Department of Occupational Therapy of the University of Rehabilitation Sciences and Social Health is required