The objective of this study was to find out the effects of spider cage therapy on motor control of hemiplegic cerebral palsy children
Design
Study design was randomized clinical trials
Sampling techniques non probability purposive sampling technique used and subject was allocated in two groups. Randomization was done by lottery method
Study population were spastic hemiplegic cp
Study Duration 4 moths
Sample size 28 calculated by EPI tool
Settings and conduct
Mubarak medical complex new block sargodha
Khawaja arshad hospital sargodha
District head quarter sargodha
Group A receive spider cage therapy session was consist of 5 days in a week for 9 months. spider cage used to control motor function like kneeling, half kneeling, one leg standing and jumping. Gross motor function scale-88 ( item c, d and e) used to determine motor abilities of cp child. in start of session general body warm up exercises like neck rotation, Elbow flexion and extension, knee extension and ankle rotation
Main outcome variables
Gross motor function scale 88 was used for categorize motor abilities of individual of cerebral palsy as baseline start of intervention. While Modified Ashworth scale was used for spasticity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230707058703N1
Registration date:2023-09-27, 1402/07/05
Registration timing:registered_while_recruiting
Last update:2023-09-27, 1402/07/05
Update count:0
Registration date
2023-09-27, 1402/07/05
Registrant information
Name
Aleena Mubarak
Name of organization / entity
The university of faisalabad
Country
Pakistan
Phone
+92 48 3750816
Email address
aleenachaudhry42@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-24, 1402/07/02
Expected recruitment end date
2023-10-24, 1402/08/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects Of Spider Cage Therapy On Motor Control Of Hemiplegic Cerebral Palsy Children
Public title
Effects Of Spider Cage Therapy On Motor Control Of Hemiplegic Cerebral Palsy Children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children diagnosed with hemiplegic cerebral palsy
Age between 4-10
Both male and females
Modified Ashworth Scale ( Grade 2)
Able to cooperate and motivated was include in the study
Cp children who was able to understand and follow verbal commands was added in training and evaluation
Gross motor function scale level: II
Exclusion criteria:
Children with severe disability, seizure instability waiting for surgery
Mentally retarded
Multiple contractures
Multiple any bone diseases
Multiple deformity
Hemiplegic with meningitis
Age
From 4 years old to 10 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
According to inclusion criteria, all the enrolled participants would be allocated into two groups.
Randomly allocated by lottery method.
Participants would be randomly assigned to two groups one group was experimental group this group received spider cage therapy.
While second group was control group received conventional therapy.
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 Review Commitee
Street address
University Avenue, Faisal town canal road, Faisalabad
City
Faisalabad
Postal code
38000
Approval date
2023-09-08, 1402/06/17
Ethics committee reference number
TUF/DR/SA/MSPP/2023/246
Health conditions studied
1
Description of health condition studied
Hemiplegic cerebral palsy children
ICD-10 code
Hemiplegic
ICD-10 code description
G80.2
Primary outcomes
1
Description
Gross motor function scale -88(item b, c and d)
Timepoint
Before intervention and 3,6 and 9 week after intervention
Method of measurement
Gross motor function scale-88 used to measure the motor ability of hemiplegic cerebral palsy childeren by using spider cage unit
Secondary outcomes
1
Description
Modified Ashworth scale
Timepoint
Baseline , 3,6 and 9 week
Method of measurement
Modified ashworth scale used to measure the spasticity of hemiplegic cerebral palsy children
Intervention groups
1
Description
“Intervention group:” This group received spider cage therapy for motor control like kneeling, half kneeling, one leg standing and jumping by using gross motor function scale. Five days in a week. Start with general body warm exercises then spider cage therapy
Category
Rehabilitation
2
Description
“Control group:” this group received conventional therapy in which stretching exercises were performed. Before this general body warm exercise were performed thẹn stretching exercises. 5 days in a week.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Mubarak medical complex new block sargodha
Full name of responsible person
Dr. alina chaudhry
Street address
Satellite town a block
City
Sargodha
Postal code
40100
Phone
+92 48 3220262
Email
Info@mubarakmc.com
2
Recruitment center
Name of recruitment center
Khawaja arshad hospital sargodha
Full name of responsible person
Dr. farjad afzal
Street address
Sarellite town 394
City
Sargodha
Postal code
40100
Phone
+92 48 3258099
Email
Inf0@khawaja.com
3
Recruitment center
Name of recruitment center
District head quarter sargodha
Full name of responsible person
Dr.nazar hussain
Street address
4, mianwali road sargodha
City
Sargodha
Postal code
40100
Phone
+92 48 9230340
Email
Info@dhq.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The university of faisalabad
Full name of responsible person
Aleena mubarak
Street address
House no 39,40 block b cant view sargodha
City
Sargodha
Postal code
40100
Phone
+92 48 3750816
Email
Aleenachaudhry42@gmail.com
Grant name
No grant name
Grant code / Reference number
No grant code
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Self funding
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
The university of faisalabad
Full name of responsible person
Aleena mubarak
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
House no 39, 40 block b cant view sargodha
City
Sargodha
Province
Punjab
Postal code
40100
Phone
+92 48 3750816
Email
Aleenachaudhry42@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nusrat abdul rauf center of enablement
Full name of responsible person
Areesha jameel
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
709-b peoples colony no 1
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 321 7607141
Email
Baigasma95@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Asma baig
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
709-b peoples colony no 1
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 321 7607141
Email
Baigasma95@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Effects of spider cage therapy on motor control of hemiplegic cerebral palsy children.
A randomization clinical trial
When the data will become available and for how long
Data will be available for other people almost 6 months after the completion of study
To whom data/document is available
Data will be available for other people almost 6 months after the completion of study
Under which criteria data/document could be used
The data/document could be used by communicating with the principle investigator Aleena Mubarak gmail: aleenachaudhry42@gmail.com
From where data/document is obtainable
Aleena Mubarak gmail: aleenachaudhry42@gmail.com
What processes are involved for a request to access data/document
The data/document could be used by communicating with the principle investigator Aleena Mubarak gmail: aleenachaudhry42@gmail.com