Evaluation of the effectiveness of mirror therapy on lower limb motor function in children with hemiplegic cerebral palsy aged 5 to 12 years.
Design
The clinical trial consists of a control group and a treatment group, double blind study, randomized by lottery method.
Settings and conduct
To evaluate people, they refer to the movement laboratory of Shahid Beheshti Rehabilitation School and to perform the intervention to Tavanyab Rehabilitation Clinic. At the beginning and end of the intervention, two stages of evaluation are performed and one month after the end of the intervention, the last stage of evaluation is performed.
Participants/Inclusion and exclusion criteria
Having a diagnosis of spastic hemiplegia cerebral palsy
Ability to walk independently at least 10 meters
Absence of uncontrolled seizures
No orthopedic surgery on the lower extremities
Absence of fixed limitations in the lower limb joints
Do not inject Botox for at least 6 months before the intervention
No visual or auditory problems that have not been corrected or treated
Ability to follow verbal instructions
GMFCS levels one and two
Absence of hemianopsia and unilateral neglect
Absence of other neurological diseases
The modified Ashworth Scale is less than 3
Intervention groups
The intervention is held for both groups 5 sessions per week for one month. Each session consists of 30 minutes of conventional occupational therapy intervention and 15 minutes of mirror therapy. Then, while people should look at the image of a healthy body in the mirror (in the control group, people look at the image of the affected side in the mirror), people are asked to do the following three movements: 1. Ankle dorsiflexion with knee extension 2.flexion knee, ankle and hip joints 3. flexion the knee more than 90 degrees.
Main outcome variables
Static/dynamic balance, step/stride length, stance/swing phase time, spasticity score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211106052977N1
Registration date:2022-08-12, 1401/05/21
Registration timing:retrospective
Last update:2022-08-12, 1401/05/21
Update count:0
Registration date
2022-08-12, 1401/05/21
Registrant information
Name
Javad Alipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8803 2381
Email address
j.alipour76@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-10, 1400/02/20
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
2021-06-22, 1400/04/01
Actual recruitment end date
2022-07-21, 1401/04/30
Trial completion date
2022-08-06, 1401/05/15
Scientific title
The efficacy of mirror therapy on lower limb motor function in children with Hemiplegic cerebral palsy 5 to 12 years
Public title
The effect of mirror therapy on the lower extremities of children with Hemiplegic cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The child should be between 5 and 12 years old.
The child should be diagnosed with spastic hemiplegia according to a pediatric neurologist.
The child must be able to walk independently at least 10 meters.
The child's muscle tone should be less than 3 on the MODIFIED ASHWORTH scale.
The child must be able to follow verbal instructions.
The child should be at levels one and two according to the GMFCS scale in terms of gross motor function.
Exclusion criteria:
The child has uncontrolled seizures.
The child has a cognitive disability according to medical history.
The child has a problem with hemianopia and unilateral neglect.
The child has other neurological diseases.
The child has had orthopedic surgery on the lower limb according to medical history.
The child has a fixed limit on range of motion in the lower limb joints.
According to medical history, the child has Auditory acuity problems that have not been corrected or treated.
According to medical history, the child has Visual acuity problems that have not been corrected or treated.
The child had a Botox injection in the lower limb for up to 6 months before the intervention.
Age
From 5 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
24
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
By simple random sampling using lottery (random allocation law) and without placement (according to the number of people in both groups, the two letters A and B, where the letter A represents the control group and the letter B represents the treatment group, on paper In the next step, the papers are poured into the bag, then the papers are randomly removed from the bag without replacement and the sequence created is recorded.) The children are divided into a control group and a treatment group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research, participants are unaware that they are in the control or treatment group because the treatment group receives mirror therapy and the control group receives sham therapy. The evaluator is also unaware of the assignment of individuals to the control and treatment group. In addition, the data analyzer is unaware of assigning individuals to the control and treatment groups because they are defined as groups A and B.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
No 26, shiraz Street, west zayandeh rood Avenue, vanak square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1991613651
Approval date
2021-03-09, 1399/12/19
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.1382
Health conditions studied
1
Description of health condition studied
cerebral palsy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Dynamic balance score in the timed up and go test
Timepoint
Determining the dynamic balance score before the intervention, at the end of the intervention period and one month after the intervention
Method of measurement
Timed Up and Go Test
2
Description
Static balance score in the pediatric balance scale
Timepoint
Determining the static balance score before the intervention, at the end of the intervention period and one month after the intervention
Method of measurement
pediatric balance scale
3
Description
Step length obtained by analyzing data of gait analysis system
Timepoint
Determining the length of the step before the intervention, at the end of the intervention period and one month after the intervention
Method of measurement
gait analysis system
4
Description
stride length obtained by analyzing data of gait analysis system
Timepoint
Determining the length of the stride before the intervention, at the end of the intervention period and one month after the intervention
Method of measurement
gait analysis system
5
Description
stance phase time obtained by analyzing data of gait analysis system
Timepoint
Determining the stance phase time before the intervention, at the end of the intervention period and one month after the intervention
Method of measurement
gait analysis system
6
Description
swing phase time obtained by analyzing data of gait analysis system
Timepoint
Determining the swing phase time before the intervention, at the end of the intervention period and one month after the intervention
Method of measurement
gait analysis system
7
Description
Spasticity score calculated using the modified Ashworth scale.
Timepoint
Determination of spasticity before the intervention, at the end of the intervention period and one month after the intervention
Method of measurement
modified Ashworth scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group undergoes rehabilitation treatment 5 days a week for 4 weeks. In each session, 30 minutes of conventional occupational therapy intervention and 15 minutes of mirror therapy intervention are performed (10 minutes of rest is provided between occupational therapy and mirror therapy), in which a mirror is placed vertically between the two lower limbs so that People see the healthy side in the mirror, then while people should look at the image of a healthy body in the mirror, they are asked to do the following three movements: 1. Ankle dorsiflexion with knee extension 2. hip & knee & ankle flexion 3. knee flexion more than 90 degrees.
Category
Rehabilitation
2
Description
Control group: This group undergoes rehabilitation treatment 5 days a week for 4 weeks. In each session, 30 minutes of conventional occupational therapy intervention and 15 minutes of mirror therapy intervention are performed (10 minutes of rest is provided between occupational therapy and mirror therapy), in which a mirror is placed vertically between the two lower limbs so that People see the unhealthy side in the mirror, then while people should look at the image of a healthy body in the mirror, they are asked to do the following three movements: 1. Ankle dorsiflexion with knee extension 2. hip & knee & ankle flexion 3. knee flexion more than 90 degrees.
Vice Chancellor for Research and Technology of Shahid Beheshti University of Medical Sciences
Street address
Floor 5, Headquarters Building 2, Shahid Beheshti University of Medical Sciences and Health Services, Shahid Abbas Arabi St., Yemen St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No. 26, West zayandeh rood Ave, Shiraz Street, Molla sadra street, Vanak square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1991613651
Phone
+98 21 8803 2381
Fax
Email
j.alipour76@sbmu.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
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Data related to the main outcomes and demographic factors can be shared after the individuals are not identified.
When the data will become available and for how long
It is possible to start the data access period after 6 months from the printing of the results.
To whom data/document is available
Research-related data is only available upon request to researchers affiliated with academic institutions.
Under which criteria data/document could be used
Research-related data and documentation can only be used if used in conjunction with related research.
From where data/document is obtainable
To receive the documents, researchers can apply by sending a message with sufficient explanations to j.alipour76@gmail.com to receive the documents and data.
What processes are involved for a request to access data/document
After sending the message to the mentioned email, the researchers will be notified of the result of the request after one to two weeks.