To determine effects of routine physical therapy with and without kinesiology tapping on postural control in spastic diaplegic cerebral palsy in children
Design
Single blinded, parallel groups, Randomized controlled trial
Settings and conduct
Setting was University of Lahore teaching hospital, Lahore. Study was single blinded.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
• Diagnosed Spastic diplegic Cerebral Palsy in children
• Both male and female
• Age ranges from 2 to 8 years.
• Classified in GMFCS LEVEL I-II
• Spastic diplegic CP with kyphosis and sitting problem.
• The muscle tone of lower limbs ranged according to the Modified Ashworth Scale (MAS) for grade 1 to +1.
Exclusion Criteria
• Hip dislocation, Kyphosis, Severe spasticity
• Previous history of spinal or hip surgery
• Botulinum toxin injection in the past 6 month
• Previous history of hypersensitivity reaction to KT
Intervention groups
Group A received KT in addition to routine physical therapy
Group B received only physical therapy.
Main outcome variables
Main variables were postural control in standing and sitting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191218045787N1
Registration date:2020-02-26, 1398/12/07
Registration timing:retrospective
Last update:2020-02-26, 1398/12/07
Update count:0
Registration date
2020-02-26, 1398/12/07
Registrant information
Name
Zain ul abbas
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 56 3785097
Email address
zain.abbas@uipt.uol.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-11-30, 1398/09/09
Actual recruitment start date
2019-07-26, 1398/05/04
Actual recruitment end date
2019-12-19, 1398/09/28
Trial completion date
2641-03-10, 2019/12/19
Scientific title
Effects of routine physical therapy with and without kinesio taping on postural control in spastic diaplegic Cerebral pasly children
Public title
Effects of routine physical therapy with and without kinesio taping on postural control in spastic diaplegic Cerebral pasly children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed Spastic diplegic Cerebral Palsy in children
Both male and female
Age ranges from 2 to 8 years
Classified in GMFCS LEVEL I-II
Spastic diplegic CP with kyphosis and sitting problem.
The muscle tone of lower limbs ranged according to the Modified Ashworth Scale (MAS) for grade 1 to +1.
Exclusion criteria:
Botulinum toxin injection in the past 6 month•
Hip dislocation, Kyphosis, Severe spasticity
Previous history of spinal or hip surgery
Previous history of hypersensitivity reaction to KT
Age
From 2 years old to 8 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Actual sample size reached:
53
Randomization (investigator's opinion)
Randomized
Randomization description
we allocated numbers to participants in advance and then generated a table of random numbers based on these numbers.
Simple randomization was done with the help of a random number table generated with excel. The first number was allocated to group-A and the second number was allocated to group-B and the same pattern was followed for the rest of the study participants for treatment allocation.
Blinding (investigator's opinion)
Single blinded
Blinding description
It was a single blinded study. The assessor was blinded
. while ensuring confidentiality. An initial assessment of all patients was done by a trained physical therapist before allocation who was not allowed any access to allocation process and treatment. The treatment plan for both groups was executed by the researcher himself. post trial assessment was performed by a physiotherapist having more than 5 years of experience in clinical field.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional reviw board Faculty of Allied health sciences
Street address
1-km defence road Lahore
City
Lahore
Postal code
54000
Approval date
2019-04-26, 1398/02/06
Ethics committee reference number
IRB-UOL-FAHS/522/2019
Health conditions studied
1
Description of health condition studied
Cerebral Palsy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Postural control in standing and sitting
Timepoint
At baseline, at 3rd week, at 6th week, 9th week and 12th week
Method of measurement
Gross motor function classification system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Rehabilitation
2
Description
Control group:
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
University of Lahore teaching hospital
Full name of responsible person
Dr Wardah Raoof
Street address
1-Km Defence road Lahore
City
Lahore
Postal code
54000
Phone
+92 42 32560865
Email
wardah.rauf@uipt.uol.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Prof Dr. Ashfaq Ahmad
Street address
1-km defence road lahore
City
Lahore
Postal code
54000
Phone
+92 42 32300865
Email
ashfaq.ahmad@uipt.uol.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Lahore
Proportion provided by this source
100
Public or private sector
Private
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 Lahore
Full name of responsible person
Zain Ul Abbas
Position
Lecturer
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
56A, Jafria Colony, Bund Road, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 56 3785097
Fax
Email
zain.abbas@uipt.uol.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Zain Ul Abbas
Position
Lecturer
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
56A, Jafria Colony, Bund Road, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 56 3785097
Fax
Email
zain.abbas@uipt.uol.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Zain Ul Abbas
Position
Lecturer
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
56A, Jafria Colony, Bund Road, Lahore
City
Lahore
Province
Punjab
Postal code
54000
Phone
+92 56 3785097
Fax
Email
zain.abbas@uipt.uol.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD