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IRCT20211221053479N1 IRCT 2022-01-02 University of Lahore Vestibular stimulation's effect on balance and motor function in cerebral palsy patients Effects of vestibular stimulation on motor function and balance in children with hypotonic cerebral palsy : A Randomized Controlled Trial 2021-07-01 anticipated 68 Complete https://irct.ir/trial/60797 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Hypotonic cerebral palsy. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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: Data will become available from 12_06_2022 to 12_07_2023 To whom: Those involved in research related to Cerebral Palsy's Interventions Conditions: For citation purposes only. Where to obtain: Data will be obtained from Principal investigator via email using the email address zulfiqar1991khan@gmail.com How to obtain: Data can be accessed Upon request to principal investigator via Email. And the mailing address is zulfiqar1991khan@gmail.com Comments:
public Mahwash Zulfiqar
118 /3A Judicial Colony Phase 2, Lahore
Lahore Pakistan 537000 +92 335 5077906 Zulfiqar1991khan@gmail.com University of Lahore scientific Mahwash Zulfiqar
118 /3A judicial colony phase 2, Lahore
Lahore Pakistan 537000 +92 335 5077906 Zulfiqar1991khan@gmail.com University of Lahore Pakistan 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 5 years 10 years Both 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. G80 Cerebral palsy Treatment - Other Treatment - Other 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 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 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. 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. University of Lahore Approved 2021-07-01 Ethics committee of University of Lahore 1km.off defence road, Lahore Lahore Punjab Pakistan