The effect of conventional physiotherapy plus ankle kinesiotaping on walking and balance in children with spastic diplegia (a randomized clinical trial)
Determining the effect of conventional physiotherapy plus kinesiotape on walking and balance in children with spastic diaplegia
Design
Clinical trial with control group (10 in each treatment group), double blinded, randomized (simple randomization with coin
Settings and conduct
In initiation, the end of treatmrnt and follow-up (6 weeks after the end of the treatment sessions) outcomes are evaluated by GMFM and MTUG and PBS. according to subject's group, routine physiotherapy/routine physiotherapy plus ankle kinesiotaping are performed at the Physiotherapy Clinic of the Faculty of Rehabilitation, Jundishapur University of Ahwaz for 4 weeks. subject due to age and data analyzer will be blind of intervention type and grouping.
Participants/Inclusion and exclusion criteria
spastic diaplegia children/ age less than 9 years, ability to stand and walk, Diagnosis of spastic diplegia by the physician, Ability to understand the therapist's commands/ History of surgery or botulinum toxin injection up to 6 months before starting treatment, Allergy to kinesiotape, Lack of parenting with the plan, Tumoral lesions, History of any lower limb corrective surgery
Intervention groups
Control group: Routine physiotherapy treatment include Gastrosoleus & hip adductors stretch, Tibialis anterior & knee extensors strengthening with FES and postural & walking training/Intervention group: Routine physiotherapy treatment plus ankle kinesioping with the aim of correcting equinus
Main outcome variables
walking and balance of spastic diaplegia children
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181211041931N1
Registration date:2019-03-11, 1397/12/20
Registration timing:prospective
Last update:2019-03-11, 1397/12/20
Update count:0
Registration date
2019-03-11, 1397/12/20
Registrant information
Name
Bahare Ziaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3108
Email address
ziaei.b@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of conventional physiotherapy plus ankle kinesiotaping on walking and balance in children with spastic diplegia (a randomized clinical trial)
Public title
The effect of conventional physiotherapy plus ankle kinesiotaping on walking and balance in children with spastic diplegia (a randomized clinical trial)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age less than 9 years
Ability to stand and walk independently or with auxiliary equipment
Diagnosis of spastic diplegia by the physician
The cognitive ability to follow verbal commands and instructions for testing
Exclusion criteria:
History of surgery or botulinum toxin injection up to 6 months before starting treatment
Allergy to kinesiotape
Lack of parental support with the child's treatment plan
Tumor lesions
Damage to the central nervous system following any trauma
History of any lower limb corrective surgery
Age
To 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by Coin. The heads in order to place the patient in the treatment group and the tails means the patient is in the control group
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and analyzer are unaware of the type of treatment
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794-61357
Approval date
2019-02-02, 1397/11/13
Ethics committee reference number
IR.AJUMS.REC.1397.820
Health conditions studied
1
Description of health condition studied
spastic diplegic cerebral palsy
ICD-10 code
G80.1
ICD-10 code description
Spastic diplegic cerebral palsy
Primary outcomes
1
Description
Score of gross motor function measure test
Timepoint
At the beginning of the study, the end of the study (4 weeks), 6 weeks after the end of the study
Method of measurement
Level of walking and standing performance
2
Description
Score of modified time up and go test
Timepoint
At the beginning of the study, the end of the study (4 weeks), 6 weeks after the end of the study
Method of measurement
Time to get up and walk a certain distance
3
Description
Score of pediatric balance scale test
Timepoint
At the beginning of the study, the end of the study (4 weeks), 6 weeks after the end of the study
Method of measurement
Performing static and dynamic equilibrium activities
Secondary outcomes
empty
Intervention groups
1
Description
Control group: conventional physiotherapy
Category
Rehabilitation
2
Description
Intervention group: conventional physiotherapy plus ankle kinesiotape
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy Clinic of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Gholamhossein nassadj
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3743 1013
Email
nassadj@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad badavi
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Gholamhossein nassadj
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-33133
Phone
+98 61 3337 4310
Email
nassadj@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Gholamhossein nassadj
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-33133
Phone
+98 61 3337 4310
Email
nassadj@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Bahare Ziaei
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-33133
Phone
+98 61 3337 4310
Email
ziaei.b@ajums.ac.ir
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The whole potential data is unpublished after being unidentifiable
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Data will only be available to researchers working in academic and academic institutions
Under which criteria data/document could be used
If someone wants to do the same research project
From where data/document is obtainable
Executor of plan: Dr.Gholamhossein nassadj E-mail: nassadj@yahoo.com
What processes are involved for a request to access data/document
By sending an E-mail with a full explanation of the reason for requesting the documentation and the purpose of having it.