The aim of the study is to compare the effect of expanded constraint induced movement therapy (eCIMT) versus routine physical therapy in treating paretic arm of children with cerebral palsy
Design
Single blinded Randomized controlled trial
Settings and conduct
Data was collected from children hospital Lahore
lottery method of randomization was used and was done by one of the research members who was not involve in recruitment or assessment or data analysis. Outcome assessor was also unaware of group assignment.
Participants/Inclusion and exclusion criteria
Age, Gender, spastic hemiplegic cerebral palsy, non use of more affected upper extremity, minimal ability to grasp the object
known case of seizures ,anti epileptic drugs, visual problems, paretic hand surgery, cognitive or sensory disorder
Intervention groups
Two groups
Experimental group
Control group
Main outcome variables
Pediatric motor activity log scale(PMAL)
Wolf motor function test(WMFT)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210706051803N1
Registration date:2021-07-18, 1400/04/27
Registration timing:retrospective
Last update:2021-07-18, 1400/04/27
Update count:0
Registration date
2021-07-18, 1400/04/27
Registrant information
Name
wajeeha bakhat
Name of organization / entity
University of lahore
Country
Pakistan
Phone
+92 42 35918862
Email address
wajeehabakhat@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-04, 1399/09/14
Expected recruitment end date
2021-07-31, 1400/05/09
Actual recruitment start date
2020-12-25, 1399/10/05
Actual recruitment end date
2021-04-04, 1400/01/15
Trial completion date
2021-04-04, 1400/01/15
Scientific title
Effect of Expanded Constraint induced movement therapy on hand function in children with cerebral palsy: A Randomized Controlled trial
Public title
Effect of Expanded Constraint induced movement therapy on hand function in children with cerebral palsy: A Randomized Controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 5-12 years both female and male
participants with diagnosis of spastic hemiplegic cerebral palsy as diagnosed and reported in the medical history by a physician
considerable nonuse of the more affected upper extremity
minimal ability to actively grasp and stabilize an object with the more impaired hand
Exclusion criteria:
known case of seizure and on anti epileptic drugs
visual problems interfering with treatment
any surgery on the paretic hand with in past 1 year
severe cognitive or sensory disorder, severe concurrent illness or disease not typically associated with CP, active medical conditions, and any major surgery or nerve blockage in the previous 6 months prior to the exposure to CP.
Age
From 5 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
38
Actual sample size reached:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized controlled trial was used.
lottery method of randomization was used and was done by one of the research team members who was not involved in patient recruitment or assessment or data analysis. Randomization assignments was kept in opaque sealed envelopes and unsealed by a researcher after baseline testing.
Blinding (investigator's opinion)
Single blinded
Blinding description
Single blinded Randomized controlled trial
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of The University of Lahore
Street address
House no 70,Ghazi block, Sector F, Bahria town Lahore
City
Lahore
Postal code
53720
Approval date
2020-12-03, 1399/09/13
Ethics committee reference number
IRB-UOL-FAHS/792/2020
Health conditions studied
1
Description of health condition studied
cerebral palsy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pediatric motor activity log scale (PMAL)
Timepoint
3 WEEKS
Method of measurement
22 ITEMS SCALE (HW) (HO)
Secondary outcomes
1
Description
WOLF MOTOR FUNCTION TEST (WMFT)
Timepoint
3 WEEKS
Method of measurement
16 ITEM SCALE CONSIST OF STRENGTH,FUNCTIONAL ABILITY AND TIME
Intervention groups
1
Description
Control group: Routine physical therapy
Category
Rehabilitation
2
Description
Intervention group: EXPANDED CONSTRAINT INDUCED MOVEMENT THERAPY(eCIMT)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Children hospital Lahore
Full name of responsible person
Wajeeha bakhat
Street address
House no 70 Ghazi block, sector F bahria town lahore
City
Lahore
Postal code
53720
Phone
+92 42 35918862
Email
wajeehabakhat@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Lahore
Full name of responsible person
Ashfaq Ahmed
Street address
UOL, Defence Road Lahore
City
Lahore
Postal code
53720
Phone
+92 42 35963424
Email
wajeehabakhat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
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
Wajeeha bakhat
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House no.70 Ghazi block ,Sector F, bahria town lahore
City
Lahore
Province
Punjab
Postal code
53720
Phone
+92 42 35918862
Email
wajeehabakhat@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Wajeeha Bakhat
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House no 70,Ghazi block, sector F, bahria town Lahore
City
Lahore
Province
Punjab
Postal code
53720
Phone
+92 42 35918862
Email
wajeehabakhat@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Wajeeha bakhat
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House no 70 Ghazi block ,Sector F, bahria town lahore
City
Lahore
Province
Punjab
Postal code
53720
Phone
+92 42 35918862
Email
wajeehabakhat@gmail.com
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
no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available