Effect of Constraint-Induced Movement Therapy along with conventional therapy and conventional therapy alone on upper extremity spasticity in children with Cerebral Palsy.
To determine the effect of constraint-induced movement therapy along with conventional therapy and conventional therapy alone on upper extremity spasticity in children with cerebral palsy.
Design
Quasi-Experimental Study
Settings and conduct
Faisal Hospital Faisalabad
Children Hospital Faisalabad
Day Care Centre Faisalabad
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Age 4-12 years.
Both genders.
Children with diagnosed upper extremity spastic cerebral palsy.
Children with minimum grade 1+ on modified Ashworth scale.
Exclusion criteria:
Children with Intellectual disability
Children who had concomitant sight and hearing disabilities
Children with previous six months history of hand surgery.
Children with uncontrolled seizures
Children with severe health problems not typically associated with CP
Children with contractures that limit functional arm and hand use
Intervention groups
Treatment will be provided three times a week for 4 weeks.
Group A will receive constraint-induced movement therapy along with conventional therapy.
Main outcome variables
Modified Ashworth Scale
Quality of Life Questionnaire for Children (CP QOL-Child)
General information
Reason for update
Acronym
CIMTCP
IRCT registration information
IRCT registration number:IRCT20220411054500N1
Registration date:2022-04-29, 1401/02/09
Registration timing:registered_while_recruiting
Last update:2022-04-29, 1401/02/09
Update count:0
Registration date
2022-04-29, 1401/02/09
Registrant information
Name
Tehreem Jameel
Name of organization / entity
Government College University
Country
Pakistan
Phone
+92 313 8113973
Email address
tehreemclick123@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-01, 1401/01/12
Expected recruitment end date
2022-07-01, 1401/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Constraint-Induced Movement Therapy along with conventional therapy and conventional therapy alone on upper extremity spasticity in children with Cerebral Palsy.
Public title
Effect of Constraint-Induced Movement Therapy along with conventional therapy and conventional therapy alone on upper extremity spasticity in children with Cerebral Palsy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 4-12 years
Both genders.
Children with diagnosed upper extremity spastic cerebral palsy.
Children with minimum grade 1+ on modified ashworth scale
Exclusion criteria:
Children with Intellectual disability
Children who had concomitent sight and hearing disabilities
Children with previous six months history of hand surgery.
Children with uncontrolled seizuresChildren with severe health problems not typically associated with CP
Children with contractures that limited functional arm and hand use
Age
From 4 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Faisal Institute of Health Sciences
Street address
673-A, Peoples Colony, Canal Road, Faisalabad.
City
Faisalabad
Postal code
48395
Approval date
2022-03-20, 1400/12/29
Ethics committee reference number
FIHS/DR/DPT/292
Health conditions studied
1
Description of health condition studied
Cerebral palsy (CP) is a disorder characterized by abnormal muscle tone, postural disabilities and movement disorders due to predominant motor syndrome. Constraint-induced movement therapy (CIMT) is referred to be an effective intervention that aid to improve motor functioning in hemiplegic cerebral palsy.
ICD-10 code
G80.9
ICD-10 code description
G80.9 is the ICD-10 code for Cerebral palsy.
Primary outcomes
1
Description
The modified Ashworth scale will be used as the primary outcome variable to assess the level of spasticity.
Timepoint
3 timepoints including baseline measurement (week 0), 2nd week post treatment and 4th week post treatment.
Method of measurement
The modified Ashworth scale will be used to measure level of spasticity.
Secondary outcomes
1
Description
Quality of Life Questionnaire for Children (CP QOL-Child) is a secondary outcome variable that is useful for evaluating Quality of Life.
Timepoint
Timepoint include 3 points including baseline measurement (week 0), 2nd week post treatment and 4th week post treatment.
Method of measurement
The CP QOL-Child is used to assess the quality of life of children aged 4-12 years
Intervention groups
1
Description
Intervention group : Constraint Induced Movement Therapy and Conventional Therapy Group
Category
Rehabilitation
2
Description
Control group: Conventional therapy group
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Faisal Hospital Faisalabad
Full name of responsible person
Dr. Rameesha Tahir
Street address
673-A, Peoples Colony, Canal Road, Faisalabad.
City
Faisalabad
Postal code
48395
Phone
+92 41 8536999
Email
fihsfsd@outlook.com
2
Recruitment center
Name of recruitment center
Children Hospital & Institute of Child Health Faisalabad
Full name of responsible person
Dr. Umair
Street address
GC university،، Jhang road، New Campus Dr, Faisalabad
City
Faisalabad
Postal code
48395
Phone
+92 41 9203065
Email
hello@instacare.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faisal Institute of Health Sciences
Full name of responsible person
Dr. Qurat ul Ain
Street address
673-A, Peoples Colony, Canal Road, Faisalabad.
City
Faisalabad
Postal code
48395
Phone
+92 41 8536999
Email
fihsfsd@outlook.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Self financed
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Faisal Institute of Health Sciences
Full name of responsible person
Dr. Tehreem Jameel
Position
Priniciple Investigator/Student
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
673-A, Peoples Colony, Canal Road, Faisalabad.
City
Faisalabad
Province
Punjab
Postal code
48395
Phone
+92 41 8536999
Email
tehreemclick123@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faisal Institute of Health Sciences
Full name of responsible person
Dr. Tehreem Jameel
Position
Priniciple Investigator/Student
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
673-A, Peoples Colony, Canal Road, Faisalabad.
City
Faisalabad
Province
Punjab
Postal code
48395
Phone
+92 41 8536999
Email
tehreemclick123@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Faisal Institute of Health Sciences
Full name of responsible person
Dr. Tehreem Jameel
Position
Priniciple Investigator/Student
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
673-A, Peoples Colony, Canal Road, Faisalabad.
City
Faisalabad
Province
Punjab
Postal code
48395
Phone
+92 41 8536999
Email
tehreemclick123@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available