The aim of our study is to determine the effects of vestibular stimulation on motor function and balance in children with hypotonic cerebral palsy
Design
Two arm parallel group randomized trial
Settings and conduct
Data will be collected from Department of Pediatric Rehabilitation, Shaikh Zayed Hospital Lahore. The study will be double blinded as care giver and assessor will be unaware of the treatment given to patient.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
• Children with age range from 5-10 years will be included in our study
• Children who will have good head control
• Patients with hypotonic cerebral palsy
• Children who will be able to maintain ring sitting position.
Exclusion Criteria:
• Children will not respond to Visual and auditory stimuli due to blindness or deafness or severe mental
retardation.
• Children with uncontrolled convulsion or shunt.
• Children with severe medical problems.
• Children with orthopedic condition
Intervention groups
Participants will be divided into two groups one will be control group which will receive only conventional physical therapy the other group will be experimental group and this group will receive vestibular stimulation along with conventional physical therapy.
Main outcome variables
Gross motor function and balance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211221053479N1
Registration date:2022-01-02, 1400/10/12
Registration timing:registered_while_recruiting
Last update:2022-01-02, 1400/10/12
Update count:0
Registration date
2022-01-02, 1400/10/12
Registrant information
Name
Mahwash Zulfiqar
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 335 5077906
Email address
msptn02193018@student.uol.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-01, 1400/04/10
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of vestibular stimulation on motor function and balance in children with hypotonic cerebral palsy : A Randomized Controlled Trial
Public title
Vestibular stimulation's effect on balance and motor function in cerebral palsy patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children of age between 5-10 year will be included in our study
Patients who will have good head control will be included
Children with Hypotonic cerebral palsy will be included in our study
Children who will be able to maintain ring sitting position will be included
Exclusion criteria:
Children who will not respond to Visual and auditory stimuli due to blindness or deafness or severe mental retardation
Children with uncontrolled convulsion or any kind of shunt
Children with severe medical problems
Children with orthopedic condition.
Age
From 5 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
68
More than 1 sample in each individual
Number of samples in each individual:
4
Data will be collected at baseline, 1st, 3rd and 5th week post intervention.
Randomization (investigator's opinion)
Randomized
Randomization description
Purposive Random Sampling technique will be carried out. For this purpose, Computer generated randomization method will be used to allocate our participants in 2 groups. Total 68 numbers will be added and the software will randomly allocate the numbers into either group A or Group B. These numbers will be given to Athetoid Cerebral palsy patient's care giver who will come to the outpatient department of physical therapy. The numbers will be assigned according to their visit i.e.those who will come first will be given 1 number in such a way as if for example the software has allocated 1 into group B, he will receive the treatment designed for group B and who will come at 10th number Will be given 10th number concealed envelope and so forth. The concealed envelope will be used for this purpose. Allocation concealment will be done by sequential numbering of patients
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be double blinded and care giver and outcome assessor will be unaware of treatment given to patients. Both the outcome assessor and caregiver will not be explained about treatment given to patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Lahore
Street address
1km.off defence road, Lahore
City
Lahore
Postal code
537000
Approval date
2021-07-01, 1400/04/10
Ethics committee reference number
IRB-UOL-FAHS/893/2021
Health conditions studied
1
Description of health condition studied
Hypotonic cerebral palsy
ICD-10 code
G80
ICD-10 code description
Cerebral palsy
Primary outcomes
1
Description
Balance
Timepoint
Balance will be assessed at baseline, 1st, 3rd and 5th week post intervention.
Method of measurement
Balance will be assessed using pediatric balance scale
2
Description
Gross motor function
Timepoint
Gross motor function will be assessed using gross motor function scale at baseline, 1st,3rd and 5th week post intervention.
Method of measurement
Gross motor function will be assessed using gross motor function scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: will receive conventional physical therapy for hypotonic cerebral palsy. For conventional physiotherapy group, the training duration for each session will be 30 minutes with 5 minutes of rest period. Participants in group A will be given Conventional Physiotherapy. It includes Passive Soft tissue elongation of tight muscles, Lower limb resistance exercises, Movement transitions, balance board and foam board standing, walking and stair climbing
Category
Treatment - Other
2
Description
Intervention group: will receive vestibular stimulation along with the routine physical therapy and for intervention group,the session will last 30 minutes with 10 minutes of rest period in between. Along with conventional physical therapy vestibular stimulation wi be given and will include exercises such as Swinging in standing in all directions, trampoline jumps, rocking movement in rocking chair,gaze stabilization exercises and visual pursuit exercises under supervision
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaikh Zayed Hospital Lahore
Full name of responsible person
Muhammad Amir Saeed
Street address
University Avenue, Block D, Muslim Town, Lahore
City
Lahore
Postal code
53700
Phone
+92 52 3310611
Email
Muhammadaamirsaeed@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Dr. Ashfaq Ahmad
Street address
1 km. Off defence road, Lahore
City
Lahore
Postal code
537000
Phone
+92 52 3310611
Email
hod@uipt.uol.edu.pk
Grant name
Postgraduation research
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Mahwash Zulfiqar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
118 /3A Judicial Colony Phase 2, Lahore
City
Lahore
Province
Punjab
Postal code
537000
Phone
+92 335 5077906
Email
Zulfiqar1991khan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Mahwash Zulfiqar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
118 /3A judicial colony phase 2, Lahore
City
Lahore
Province
Punjab
Postal code
537000
Phone
+92 335 5077906
Email
Zulfiqar1991khan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Mahwash Zulfiqar
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
118 /3A judicial colony phase 2, Lahore
City
Lahore
Province
Punjab
Postal code
537000
Phone
+92 335 5077906
Email
Zulfiqar1991khan@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
The title of our study is"EFFECTS OF VESTIBULAR STIMULATION ON MOTOR FUNCTION AND BALANCE IN CHILDREN WITH HYPOTONIC CEREBRAL PALSY: A RANDOMIZED CONTROLLED TRIAL". All collected deidentified IPD will be shared
When the data will become available and for how long
Data will become available from 12_06_2022 to 12_07_2023
To whom data/document is available
Those involved in research related to Cerebral Palsy's Interventions
Under which criteria data/document could be used
For citation purposes only.
From where data/document is obtainable
Data will be obtained from Principal investigator via email using the email address zulfiqar1991khan@gmail.com
What processes are involved for a request to access data/document
Data can be accessed Upon request to principal investigator via Email. And the mailing address is zulfiqar1991khan@gmail.com