Protocol summary

Summary
30 children with cerebral palsy of 4 to 10 years were selected randomly and divided into two groups of 15 intervention and control groups. It should be noted that selected children have the ability to walk and mentally capable of receiving and executing orders. The intervention group, in addition to the usual physical therapy and occupational therapies, also received kinesio tape, but the control group received the sham and received the usual services of physiotherapy and occupational therapy according to the past, ie the type without affecting the person was symbolic be pasted.Taping in the ankle and in the anterior tibialis muscle to improve the ankle flexion dorsi, gastrosulosis, in order to control the ankle plantar flexion, rectus femoris, in order to improve knee extension and hamstring to control flexion of the knee. For this purpose, tension is applied to facilitate muscle function from the beginning to the end of the muscle, but in the case of inhibition of the muscle, from the end to the beginning of the muscle, and for muscle tuning up to 30% of the initial length, and in case of functional correction, it will be drawn up to 100% of the initial length. The position of the child during placement of the tape should be such that the muscle is drawn. Taping is done for 14 days and is replaced by a 4 day interval. Before taping,two days after the taping and the next 14 days ( at the end of the intervention), tests and measurements are performed and the results are compared. In this study, the dorsi and knee flexural distance and ankle and knee flexion are measured and recorded, spasticity is assessed by Modified Modified Ashworth Scale, and the degree of each sample is recorded. The functional balance of the child is assessed by the Berg balance test. Forward functional reach measures the individual's balance when standing next to the wall and extending his hand. The child's functional mobility is evaluated by Timed get up and go tests and the results are recorded. The data is entered into the spss and will be analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017082135822N1
Registration date: 2017-09-19, 1396/06/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-09-19, 1396/06/28
Registrant information
Name
Mirjavad Tabatabaee Yamchi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6613 4901
Email address
ah-kohan@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Sciences
Expected recruitment start date
2017-09-09, 1396/06/18
Expected recruitment end date
2017-09-19, 1396/06/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of kinesio tape on spasticity, range of motion, balance and functional mobility in children with cerebral palsy and spastic quadriplegies
Public title
The effect of kinesio tape on children with cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. spastic diplegia or quadriplegia cerebral palsy children who have been taken by a neurologist, are enrolled; 2- children with cerebral palsy physically and mentally at least to be able to walk and to understand and execute commands; 3- children with cerebral palsy should be between 4 to 10 years; 4- no therapies will be added to the usual therapeutic physiotherapy and occupational therapy of the children studied during this period; 5- children who can come to the clinic once every 4 days have to replace the tape. Exclusion criteria: 1. added new plan that received conventional treatment; 2. if the child is allergic to the tape, the child will be excluded from the intervention; 3. if the child does not come to change the tape and distance between the two time tapping, the child will be excluded from the study.
Age
From 4 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah University of Medical Sciences, Sheikh Bahaie Street, End of Nostrad Nusrat
City
Tehran
Postal code
1435916471
Approval date
2017-05-05, 1396/02/15
Ethics committee reference number
IR.BMSU.REC.1396.47

Health conditions studied

1

Description of health condition studied
Cerebral palsy
ICD-10 code
G80
ICD-10 code description
Cerebral palsy

Primary outcomes

1

Description
Functional balance
Timepoint
14 day
Method of measurement
Forward functional reach

2

Description
Balance
Timepoint
14 day
Method of measurement
Berg balance scale

Secondary outcomes

1

Description
Range of motion
Timepoint
14 day
Method of measurement
Goniometry

2

Description
Spasticity
Timepoint
14 day
Method of measurement
Modified Modified Ashworth

3

Description
Functional mobility
Timepoint
14 day
Method of measurement
Timed get up and go

Intervention groups

1

Description
Control group received the sham and received the usual services of physiotherapy and occupational therapy according to the past, ie the type without affecting the person was symbolic be pasted.Taping in the ankle and in the anterior tibialis muscle to improve the ankle flexion dorsi, gastrosulosis, in order to control the ankle plantar flexion, rectus femoris, in order to improve knee extension and hamstring to control flexion of the knee.
Category
Placebo

2

Description
The intervention group, in addition to the usual physical therapy and occupational therapies, also received kinesio tape.Taping in the ankle and in the anterior tibialis muscle to improve the ankle flexion dorsi, gastrosulosis, in order to control the ankle plantar flexion, rectus femoris, in order to improve knee extension and hamstring to control flexion of the knee. For this purpose, tension is applied to facilitate muscle function from the beginning to the end of the muscle, but in the case of inhibition of the muscle, from the end to the beginning of the muscle, and for muscle tuning up to 30% of the initial length, and in case of functional correction, it will be drawn up to 100% of the initial length. The position of the child during placement of the tape should be such that the muscle is drawn. Taping is done for 14 days and is replaced by a 4 day interval. Before taping,two days after the taping and the next 14 days ( at the end of the intervention), tests and measurements are performed and the results are compared. In this study, the dorsi and knee flexural distance and ankle and knee flexion are measured and recorded, spasticity is assessed by Modified Modified Ashworth Scale, and the degree of each sample is recorded. The functional balance of the child is assessed by the Berg balance test. Forward functional reach measures the individual's balance when standing next to the wall and extending his hand.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tavanafarin rehabilitation Center
Full name of responsible person
Mojgan Kabki
Street address
Floor 4, No.168, Next to the gas station, Opposite the Niroye-havayi of metro station, Piroozi Street
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Alireza Shamsoddini
Street address
Sport Physiology Research Center, Baqiyatallah University of Medical Sciences, Sheikh Bahaie Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tavan Afarin Rehabilitation center
Full name of responsible person
Mirjavad Tabatabaee Yamchi
Position
MA occupational therapy
Other areas of specialty/work
Street address
Floor 4, No.168, Next to the gas station, Opposite the Niroye-havayi of metro station, Piroozi Street
City
Tehran
Postal code
Phone
+98 21 6663 3216
Fax
Email
mj.tabatabaee.ot@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tavan Afarin Rehabilitation center
Full name of responsible person
Mirjavad Tabatabaee Yamchi
Position
MA occupational therapy
Other areas of specialty/work
Street address
Floor 4, No.168, Next to the gas station, Opposite the Niroye-havayi of metro station, Piroozi Street
City
Tehran
Postal code
Phone
+98 21 6663 3216
Fax
Email
mj.tabatabaee.ot@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tavan Afarin Rehebilitation center
Full name of responsible person
Mirjavad Tabatabaee Yamchi
Position
MA occupational therapy
Other areas of specialty/work
Street address
Floor 4, No.168, Next to the gas station, Opposite the Niroye-havayi of metro station, Piroozi Street
City
Tehran
Postal code
Phone
+98 21 6663 3216
Fax
Email
mj.tabatabaee.ot@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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