Protocol summary
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Study aim
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Assessing the effect of virtual reality camera-based mirror therapy on upper extremity motor function in children with hemiplegic cerebral palsy
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2022-04-14, 1401/01/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-01-21, 1400/11/01
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Expected recruitment end date
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2022-06-05, 1401/03/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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The effect of virtual reality camera-based mirror therapy on upper extremity motor function in patients with hemiplegic cerebral palsy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 8 years old to 12 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
20
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-10-20, 1400/07/28
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Ethics committee reference number
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IR.USWR.REC.1400.168
Health conditions studied
1
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Description of health condition studied
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hemiplegic cerebral palsy
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ICD-10 code
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G80.2
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ICD-10 code description
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Spastic hemiplegic cerebral palsy
Primary outcomes
1
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Description
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Selective Control of the Upper Extremity Scale
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Timepoint
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The beginning of the intervention, after 8 weeks, the follow-up period after 4 weeks
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Method of measurement
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Selective Control of the Upper Extremity Scale Test
2
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Description
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Gross manual dexterity
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Timepoint
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The beginning of the intervention, after 8 weeks, the follow-up period after 4 weeks
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Method of measurement
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Box and block test
3
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Description
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Range of motion
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Timepoint
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The beginning of the intervention, after 8 weeks, the follow-up period after 4 weeks
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Method of measurement
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Goniometer
4
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Description
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Large hand muscles strength
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Timepoint
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The beginning of the intervention, after 8 weeks, the follow-up period after 4 weeks
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Method of measurement
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Dynamometer
5
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Description
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The strength of the delicate muscles of the hand
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Timepoint
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The beginning of the intervention, after 8 weeks, the follow-up period after 4 weeks
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Method of measurement
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Pinched gauge
6
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Description
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Quality of Upper Extremity Skills
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Timepoint
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The beginning of the intervention, after 8 weeks, the follow-up period after 4 weeks
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Method of measurement
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Quality of Upper Extremity Skills Test
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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University of social welfare and rehabilitation sciences
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Proportion provided by this source
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1
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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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.
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When the data will become available and for how long
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Access period starts 6 months after the publication of the article
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To whom data/document is available
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All experts who work in this field
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Under which criteria data/document could be used
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For clinical studies and in treatment
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From where data/document is obtainable
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Refer to the Department of Occupational Therapy at the University of Rehabilitation Sciences and Social Health
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What processes are involved for a request to access data/document
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Obtaining permission from the Department of Occupational Therapy of the University of Rehabilitation Sciences and Social Health is required
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Comments
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