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IRCT20090301001722N29 IRCT 2023-06-15 Tehran University of Medical Sciences Effects of Electrical stimulation and Whole Body vibration therapy with transcranial direct current stimulation on spactic cerebral palsy children Comparison of the conjunct effects of Electrical Stimulation and Whole-Body Vibration Therapy with Transcranial Direct Current Stimulation and Whole-body Vibration Therapy on Balance and Function in Spastic Cerebral Palsy Children. 2023-06-05 anticipated 42 Complete https://irct.ir/trial/70443 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Before the process of randomization, we will screen all the participants and assign them a unique number from 1 to 42. Then the process of randomization will be carried out using Random Allocation software version 1.0 (developed by the Department of Anaesthesia, Isfahan University of Medical Sciences, Isfahan, Iran). It is a randomization software for parallel group trials. It requires the total sample size and the total number of groups. We will add a total sample size of 42 participants and 3 groups into the software with only one block. The software generates an output file that can be opened with internet explorer. The output file contains a list of number along with assigned groups. In our case, the groups will be A, B, C with 14 participants in each group. Then this sequence will be used for participant allocation in the study groups, Blinding description: The care provider will be blinded to the groups of the study (i.e. Treatment and Control Group). While the outcome assessors will be blinded to the treatment protocols and study hypothesis. N/A Cerbral Palsy. Intervention 1: Intervention group 1 WBV training for 20 min a day,4 days a week for 4 weeks. The children will be instructed to maintain a standing posture on the vibration platform. Children will stand barefooted with feet parallel and in slight flexion (30°). The feet will be placed at an equal distance from the center line of the device when standing. During the 20 min of therapy, every 3 minutes of vibration training and 2 minutes of rest will be repeated 4 times. The frequency of the WBV stimulation will be (12–18 Hz) and will achieve gradually increase by 1 Hz per 2 seconds, till the desired frequency is achieved. Intervention 2: Intervention group 2 WBV training for 20 min a day,4 days a week for 4 weeks. The children will be instructed to maintain a standing posture on the vibration platform. Children will stand barefooted with feet parallel and in slight flexion (30°). The feet will be placed at an equal distance from the center line of the device when standing. During the 20 min of therapy, every 3 minutes of vibration training and 2 minutes of rest will be repeated 4 times. The frequency of the WBV stimulation will be (12–18 Hz) and will achieve gradually increase by 1 Hz per 2 seconds, till the desired frequency is achieved. Functional Electrical stimulation with Rectangular biphasic pulses with a pulse width of 250 μs, the stimulus intensity 70 mA, and a frequency ranged from 40 Hz,4 days a week for 4 weeks will be administered on motor points of the spastic muscles mainly for the lower extremity ( quadriceps and gastrocnemius and soleus). Intervention 3: Intervention group 3 Transcranial Direct Current Stimulation (tDCS) will be given with 2mA intensity for 20 min a day,4 days sessions a week for 4 weeks. 5*7 cm square electrodes will be placed as Anodal tDCS, will be placed over the primary motor cortex and cathodal tDCS will be placed over the contralateral supraorbital region. It will receive the WBV training for 20 min a day,4 days a week for 4 weeks. The children will be instructed to maintain a standing posture on the vibration platform. Children will stand barefooted with feet parallel and in slight flexion (30°). The feet will be placed at an equal distance from the center line of the device when standing. During the 20 min of therapy, every 3 minutes of vibration training and 2 minutes of rest will be repeated 4 times. The frequency of the WBV stimulation will be (12–18 Hz) and will achieve gradually increase by 1 Hz per 2 seconds, till the desired frequency is achieved. 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 Currently we are working on streamlining the project and data collection. After recruiting theparticipants we may be able to deidentify individual data sets
public Dr.Mohammad-Reza Hadian Rasanani
Rehabilitation Faculty, Pich e Shemiran, Enghelab Street Tehran Tehran Iran,
Terhan Iran (Islamic Republic of) 1417614411 +98 21 8891 3469 hadianrasan@gmail.com Tehran University of Medical Sciences scientific Dr. Mohammad Reza Hadian
Rehabilitation faculty, pich e shemiran, enghlab street
Tehran Iran (Islamic Republic of) 1148965141 +98 21 7753 6134 hadianrs@sina.tums.ac.ir Tehran University of Medical Sciences Pakistan Age of 5- 15 years. Both Genders (Boys and Girls). Children diagnosed with Spastic Hemiplegic cerebral palsy. Degree of Spasticity Grade 1, 1+, and 2 according to Modified Ashworth Scale in the following muscles (hip flexors, hip adductors, hamstrings and ankle plantar flexors). Level I(Can walk indoors and outdoors and climb stairs without using hands for support, and II (ability to walk indoors and outdoors and climb stairs with a railing ) of Gross Motor Function Classification System. Manual Ability Classification System level I to IV. No history of epilepsy. No unhealed fractures. No visual impairments and auditory impairments. Not taking botulinum toxin injections. Does not have any sensory and motor loss. Does not have cardiopulmonary problems. Does not have recent surgery (less than 1 year). Children who would not experience joint contractures Children with no Muscle or tendon inflammation Children with no Leg length discrepancy 5 years 15 years Both The child or the guardian is not interested to carry out the study. Failing to complete the study. Cerebral P G80 Rehabilitation Rehabilitation Rehabilitation Intervention group 1 WBV training for 20 min a day,4 days a week for 4 weeks. The children will be instructed to maintain a standing posture on the vibration platform. Children will stand barefooted with feet parallel and in slight flexion (30°). The feet will be placed at an equal distance from the center line of the device when standing. During the 20 min of therapy, every 3 minutes of vibration training and 2 minutes of rest will be repeated 4 times. The frequency of the WBV stimulation will be (12–18 Hz) and will achieve gradually increase by 1 Hz per 2 seconds, till the desired frequency is achieved. Intervention group 2 WBV training for 20 min a day,4 days a week for 4 weeks. The children will be instructed to maintain a standing posture on the vibration platform. Children will stand barefooted with feet parallel and in slight flexion (30°). The feet will be placed at an equal distance from the center line of the device when standing. During the 20 min of therapy, every 3 minutes of vibration training and 2 minutes of rest will be repeated 4 times. The frequency of the WBV stimulation will be (12–18 Hz) and will achieve gradually increase by 1 Hz per 2 seconds, till the desired frequency is achieved. Functional Electrical stimulation with Rectangular biphasic pulses with a pulse width of 250 μs, the stimulus intensity 70 mA, and a frequency ranged from 40 Hz,4 days a week for 4 weeks will be administered on motor points of the spastic muscles mainly for the lower extremity ( quadriceps and gastrocnemius and soleus). Intervention group 3 Transcranial Direct Current Stimulation (tDCS) will be given with 2mA intensity for 20 min a day,4 days sessions a week for 4 weeks. 5*7 cm square electrodes will be placed as Anodal tDCS, will be placed over the primary motor cortex and cathodal tDCS will be placed over the contralateral supraorbital region. It will receive the WBV training for 20 min a day,4 days a week for 4 weeks. The children will be instructed to maintain a standing posture on the vibration platform. Children will stand barefooted with feet parallel and in slight flexion (30°). The feet will be placed at an equal distance from the center line of the device when standing. During the 20 min of therapy, every 3 minutes of vibration training and 2 minutes of rest will be repeated 4 times. The frequency of the WBV stimulation will be (12–18 Hz) and will achieve gradually increase by 1 Hz per 2 seconds, till the desired frequency is achieved. Range of Motion. Timepoint: Before and After the intervention for Upper and lower extremity joints. Method of measurement: Universal Goniometer. Hand Grip Strength. Timepoint: Before and After the intervention for Upper Limb. Method of measurement: Hand Held Digital Dynamometer. Isometric Muscle strength test. Timepoint: Before and After the intervention for lower extremity muscles. Method of measurement: digital force gauge SF-500. Centre of Gravity, and Balance test scores. Timepoint: Before and After the intervention for lower extremity. Method of measurement: Nintendo Wii-Fit, Balance board. Gait parameters (walking speed, cadence(stride length and step length) using cinematography. Timepoint: Before and after the intervention for the lower extremity. Method of measurement: Kinovea software version 0.9.5. Timed up and go test. Timepoint: Before and After the intervention. Method of measurement: One Chair, Measurement Tape and Stop Watch. Manual dexterity. Timepoint: before and after the intervention for the upper extremity. Method of measurement: 9 hole and peg board. Modified Ashworth Scale. Timepoint: before and after intervention for upper and lower extremity. Method of measurement: Modified Ashworth Scale Questionnaire. Berg balance scale. Timepoint: before and after the intervention for spastic Cerebral palsy children. Method of measurement: Berg Balance scale questioner. Gross motor function. Timepoint: before and after the intervention for spastic crebral palsy children. Method of measurement: GMFM-88 scale ( Standing and sitting component). Tehran University of Medical Sciences Approved 2023-05-31 Tehran University of Medical Sciences (TUMS) School of Rehabilitation of Tehran University of Medical Sciences, Piche Shemiran,Enghelab Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)