Functional changes induce by Hand-Arm Bimanual Intensive Therapy including lower extremities (HABIT-ILE) in preschool children with spastic cerebral palsy
To evaluate the effects of Hand arm bimanual intensive therapy including lower extremities (HABIT-ILE), in pre-school children with CP on functional parameters
Design
Randomized controlled trial
Settings and conduct
Hospitals of Faisalabad
Participants/Inclusion and exclusion criteria
Inclusion
Both male and female Children will be considered
Diagnosed children of Spastic Cerebral Palsy
CP Child of Grade 3 and 4
aged between 3 to 6 years (corrected age if preterm birth),
capable of following instructions and completing all necessary tests according to their
Exclusion
Limb fracture
Uncontrolled epilepsy
With any other congenital disease (e.g. Diabetes, Hyperthyroidism, Hypothyroidism etc.)
Botulinum toxin injections or orthopedic surgery within the past 6 months.
Have severe visual or cognitive impairments that could interfere with treatment/testing.
Parents are unable/unwilling to provide consent for their child’s participation
Intervention groups
Group A Interventional group consist of 25 participants will receive Early Hand arm Bimanual Intensive Therapy Including Lower Extremities (E-HABIT-ILE), while Group B will receive treatment through a Conventional Physical therapy. Both interventions will be given for 3 hours per day in hospital by dividing the both groups into sub groups
Main outcome variables
1. Five classification levels of the Gross Motor Functional Classification System (GMFCS)
2. Modified ACTIVLIM-CP Questionnaire
3. Pediatric Evaluation of Disability Inventory Questionnaire (PEDI-CAT)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220930056062N5
Registration date:2024-06-14, 1403/03/25
Registration timing:prospective
Last update:2024-06-14, 1403/03/25
Update count:0
Registration date
2024-06-14, 1403/03/25
Registrant information
Name
Kaiynat Shafique
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 334 6925051
Email address
kaiynatshafique@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-19, 1403/03/30
Expected recruitment end date
2024-07-29, 1403/05/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Functional changes induce by Hand-Arm Bimanual Intensive Therapy including lower extremities (HABIT-ILE) in preschool children with spastic cerebral palsy
Public title
Hand-Arm Bimanual Intensive Therapy including lower extremities (HABIT-ILE) in preschool CP children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both male and female Children will be considered
capable of following instructions and completing all necessary tests according to their age
aged between 3 to 6 years (corrected age if preterm birth)
CP Child of Grade 3 and 4
Diagnosed children of Spastic Cerebral Palsy
Exclusion criteria:
Limb fracture
Uncontrolled epilepsy
With any other congenital disease (e.g. Diabetes, Hyperthyroidism, Hypothyroidism etc.)
Botulinum toxin injections or orthopedic surgery within the past 6 months
Have severe visual or cognitive impairments that could interfere with treatment/testing
Parents are unable/unwilling to provide consent for their child’s participation
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization through lottery method
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be blind in this clinical trial
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Government College University Faisalabad
Street address
Faisalabad
City
Faisalabad
Postal code
38000
Approval date
2024-05-10, 1403/02/21
Ethics committee reference number
GCUF/2024/0987
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
ACTIVLIM-CP Questionnaire and Pediatric Evaluation of Disability Inventory and Computer Adaptive Test Questionnaire (PEDI-CAT) will be solved on the basis of initial assessment of children. Five classification levels of the Gross Motor Functional Classification System (GMFCS) to measure the Grade of cerebral Palsy.
Timepoint
2
Method of measurement
ACTIVLIM-CP Questionnaire and Pediatric Evaluation of Disability Inventory and Computer Adaptive Test Questionnaire (PEDI-CAT) will be solved on the basis of initial assessment of children. Five classification levels of the Gross Motor Functional Classification System (GMFCS) to measure the Grade of cerebral Palsy.
Secondary outcomes
1
Description
ACTIVLIM-CP Questionnaire and Pediatric Evaluation of Disability Inventory and Computer Adaptive Test Questionnaire (PEDI-CAT) will be solved on the basis of initial assessment of children. Five classification levels of the Gross Motor Functional Classification System (GMFCS) to measure the Grade of cerebral Palsy.
Timepoint
2
Method of measurement
ACTIVLIM-CP Questionnaire and Pediatric Evaluation of Disability Inventory and Computer Adaptive Test Questionnaire (PEDI-CAT) will be solved on the basis of initial assessment of children. Five classification levels of the Gross Motor Functional Classification System (GMFCS) to measure the Grade of cerebral Palsy.
Intervention groups
1
Description
Intervention group: Early Hand arm Bimanual Intensive Therapy Including Lower Extremities (E-HABIT-ILE)
Category
Rehabilitation
2
Description
Control group: Conventional treatment
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Allied Hospital faisalabad
Full name of responsible person
Rafia Imtiaz
Street address
Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 9210092
Email
rafiaimtiaz@gcuf.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Government College University Faisalabad
Full name of responsible person
Rafia Imtiaz
Street address
Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 9210023
Email
rafiaimtiaz@gcuf.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
No funding was received
Proportion provided by this source
1
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Government College University Faisalabd
Full name of responsible person
Rafia Imtiaz
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 9200876
Email
rafiaimtiaz@gcuf.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Government College University Faisalabd
Full name of responsible person
Rafia Imtiaz
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 9200876
Email
rafiaimtiaz@gcuf.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Government College University Faisalabad
Full name of responsible person
Rafia Imtiaz
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 41 9200066
Email
rafiaimtiaz@gcuf.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
Privacy concerns
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
Yes - There is 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
Title and more details about the data/document
Functional changes induce by Hand-Arm Bimanual Intensive Therapy including lower extremities (HABIT-ILE) in preschool children with spastic cerebral palsy
When the data will become available and for how long
Data from this trial will not be made publicly available. However, it may be accessible upon request. For inquiries regarding data access, please contact rafiaimtiaz@gcuf.edu.pk.
To whom data/document is available
Data from this trial will not be made publicly available. However, it may be accessible upon request. For inquiries regarding data access, please contact rafiaimtiaz@gcuf.edu.pk.
Under which criteria data/document could be used
Data from this trial will not be made publicly available. However, it may be accessible upon request. For inquiries regarding data access, please contact rafiaimtiaz@gcuf.edu.pk.
From where data/document is obtainable
Data from this trial will not be made publicly available. However, it may be accessible upon request. For inquiries regarding data access, please contact rafiaimtiaz@gcuf.edu.pk.
What processes are involved for a request to access data/document
Data from this trial will not be made publicly available. However, it may be accessible upon request. For inquiries regarding data access, please contact rafiaimtiaz@gcuf.edu.pk.