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IRCT20210225050494N1 IRCT 2021-02-28 Ghurki trust & teaching hospital Comparison of effects of hand arm bimanual intensive therapy with and without action observation training on upper extremity motor functions in children with spastic hemiplegic cerebral palsy HABIT & AOT Effects of hand arm bimanual intensive therapy with and without action observation training on upper extremity motor functions in children with spastic hemiplegic cerebral palsy 2641-10-19 anticipated 36 Pending https://irct.ir/trial/54598 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: The basic strategy used for randomization will be the development of an ordered list with group assignments made in advance using random number table. As participants enter the study, they will be given consecutive numbers and assigned to the group indicated for each number, Blinding description: Patients will be blinded for their group allocation. They will receive their allocated treatment without the knowledge of weather they belong to the control group or interventional group. The duration on treatment session will be same for both groups. The assessor will be physical Therapist who will have no role in the treatment of the patients. The collected data will be analyzed by biostatistician who will be unaware of the group specification of data. N/A Spastic hemiplegic Cerebral palsy. Intervention 1: Intervention group: Habit with AOT will be given. Therapy will be given for total 60 hours, 3 hours a day, 5 times per week for 4 weeks. AOT will be carried out for 30 min each day, 5 days per week for 4 weeks. Total training sessions will be 20 per subject. Intervention 2: Control group: Habit without AOT will be given. Therapy will be given for total 60 hours, 3 hours a day, 5 times per week for 4 weeks. control group will receive visual stimulation and motor activities 30 mins per day, 5 times per week for 4 weeks. Total number of training sessions per subject will be 20. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is it is not yet known if there will be a plan to make this available
public Zeeshan Saeed
1 km, defence road, Off bhobatian chowk, lahore
Lahore Pakistan 54000 +92 42 35322501 zeeshans475@gmail.com University of Lahore scientific Zeeshan Saeed
1 km, defence road, Off bhobatian chowk, lahore
Lahore Pakistan 54000 +92 42 35322501 zeeshans475@gmail.com University of Lahore Pakistan Diagnosed spastic hemiplegic cerebral palsy Age 5- 12 years Mini mental state examination >24 Spasticity of grade <2 on modified ashworth scale Gross motor functional classification scale level III-IV Manual ability classification system level III- IV Sufficient cooperation and cognitive understanding to participate in the activities No sensory impairments no history of seizures parents able to commit to an intensive therapy program 5 years 12 years Both Children with visual impairments Aphasic children uncontrolled seizures previous orthopedic surgery of upper limb severe spasticity or contractures that requires orthotic management BoNT- A injection in the UL within 6 months prior to study entry G80.2 Spastic hemiplegic cerebral palsy Rehabilitation Rehabilitation Intervention group: Habit with AOT will be given. Therapy will be given for total 60 hours, 3 hours a day, 5 times per week for 4 weeks. AOT will be carried out for 30 min each day, 5 days per week for 4 weeks. Total training sessions will be 20 per subject Control group: Habit without AOT will be given. Therapy will be given for total 60 hours, 3 hours a day, 5 times per week for 4 weeks. control group will receive visual stimulation and motor activities 30 mins per day, 5 times per week for 4 weeks. Total number of training sessions per subject will be 20. Upper extremity motor functions. Timepoint: Before intervention, 4th week at completion of intervention, at 8th week for follow up. Method of measurement: ABILHAND KIDS questionnaire will be used to measure the manual ability of children. Questionnaire contains 21 activities which are rated by parents as impossible, easy, difficult. Jebson Taylor hand function test will be used to evaluate the speed of performance. It has 7 subsets of simulated daily activities and time score will be recorded for each activity. Ghurki trust & teaching hospital Approved 2641-10-19 University of Lahore 1 km, defence road, Off bhobatian chowk, lahore Lahore Punjab Pakistan