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IRCT20090301001722N27 IRCT 2023-05-29 Shifa Tameer e Millat University Effect of whole-body vibration in children with cerebral palsy Effects of Whole-Body Vibration Therapy in Weight-Bearing and Non-Weight Bearing positions for Upper and Lower Extremities on Balance and Function in Cerebral Palsy children. 2023-06-01 anticipated 60 Complete https://irct.ir/trial/64165 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 60. 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 60 participants and 6 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 Aa, Ab, Ac, Ba, Bb, and Bc with 10 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 Cerebral Palsy. Intervention 1: Intervention group: 1. The Whole-body vibration therapy in weight-bearing (WBV-WB) lower extremity group will receive the WBV training for 20 min a day, 3 days a week for a 4-week period. The children assigned to the WBV-WB group will be instructed to maintain a standing posture on a vibration platform. Children will stand barefooted with feet parallel and knees straight or in slight flexion (30°). The feet will be placed in an equal distance from the center line of the device when standing. During the 20 min of therapy, every 3 minute 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 achieved gradually increasing 1 Hz per 2 seconds, till the desired frequency is achieved. Intervention 2: Intervention group: 2. The Whole-body vibration therapy in weight-bearing (WBV-WB) upper extremity group will receive the same protocol like Lower Extremity, but in a kneeling quadruped position with the hands-on the platform. Intervention 3: Intervention group: 3. The Whole-body vibration therapy in weight-bearing (WBV-WB) combine upper and lower extremity group will receive same protocol like (Upper and Lower Extremity Protocol Mentioned above) in standing on one whole-body vibrator while leaning on the other whole-body vibrator with hands. A total of 2 Whole body vibration units will be used simultaneously. Intervention 4: Intervention group: 4. The Whole-body vibration therapy in non weight-bearing (WBV-NWB) lower extremity group will receive the WBV training for 20 min a day, 3 days a week for a 4-week period. The children assigned to the WBV-NWB group will be instructed to maintain seated posture on a chair. Children will place their feet on the whole-body vibrator. During the 20 min of therapy, every 3 minute 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 achieved gradually increasing 1 Hz per 2 seconds, till the desired frequency is achieved. Intervention 5: Intervention group: 5. The Whole-body vibration therapy in non weight-bearing (NWBV-WB) upper extremity group will receive the same protocol like Lower Extremity, but in seated position with the hands-on on the platform. Intervention 6: Intervention group: 6. The Whole-body vibration therapy in non weight-bearing (NWBV-WB) combine upper and lower extremity group will receive same protocol like (Upper and Lower Extremity Protocol Mentioned above) in seated position. One platform will be under the feet and the other will be under the hands. A total of 2 Whole body vibration units will be used simultaneously. 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 the participants 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,
Tehran 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) With a diagnosis of spastic cerebral palsy. Degree of Spasticity Grade 1, 1+ and 2 according to Modified Ashworth Scale. Mild Severity of cerebral palsy Level I and II of Gross Motor Function Classification System 5 years 15 years Both Children with fixed musculoskeletal deformities With a history of recent surgery (less than 1 year) Unhealed fractures Any case of epilepsy or visual or auditory problems Under treatment with botulinum toxin Non-Spastic cerebral palsy (Ataxic, Dyskinetic etc.) Children having Sensory loss in upper and lower extremity. G80 Cerebral palsy Rehabilitation Rehabilitation Rehabilitation Rehabilitation Rehabilitation Rehabilitation Intervention group: 1. The Whole-body vibration therapy in weight-bearing (WBV-WB) lower extremity group will receive the WBV training for 20 min a day, 3 days a week for a 4-week period. The children assigned to the WBV-WB group will be instructed to maintain a standing posture on a vibration platform. Children will stand barefooted with feet parallel and knees straight or in slight flexion (30°). The feet will be placed in an equal distance from the center line of the device when standing. During the 20 min of therapy, every 3 minute 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 achieved gradually increasing 1 Hz per 2 seconds, till the desired frequency is achieved. Intervention group: 2. The Whole-body vibration therapy in weight-bearing (WBV-WB) upper extremity group will receive the same protocol like Lower Extremity, but in a kneeling quadruped position with the hands-on the platform. Intervention group: 3. The Whole-body vibration therapy in weight-bearing (WBV-WB) combine upper and lower extremity group will receive same protocol like (Upper and Lower Extremity Protocol Mentioned above) in standing on one whole-body vibrator while leaning on the other whole-body vibrator with hands. A total of 2 Whole body vibration units will be used simultaneously. Intervention group: 4. The Whole-body vibration therapy in non weight-bearing (WBV-NWB) lower extremity group will receive the WBV training for 20 min a day, 3 days a week for a 4-week period. The children assigned to the WBV-NWB group will be instructed to maintain seated posture on a chair. Children will place their feet on the whole-body vibrator. During the 20 min of therapy, every 3 minute 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 achieved gradually increasing 1 Hz per 2 seconds, till the desired frequency is achieved. Intervention group: 5. The Whole-body vibration therapy in non weight-bearing (NWBV-WB) upper extremity group will receive the same protocol like Lower Extremity, but in seated position with the hands-on on the platform. Intervention group: 6. The Whole-body vibration therapy in non weight-bearing (NWBV-WB) combine upper and lower extremity group will receive same protocol like (Upper and Lower Extremity Protocol Mentioned above) in seated position. One platform will be under the feet and the other will be under the hands. A total of 2 Whole body vibration units will be used simultaneously. Modified Ashworth Scale. Timepoint: Before and After the intervention for Upper Limb and lower limb in weight bearing and non weight bearing position. Method of measurement: Modified Ashworth Scale Questionnaire. Timed up and go test. Timepoint: Before and After the intervention for Upper Limb and lower limb in weight bearing and non weight bearing position. Method of measurement: One Chair, Measurement Tape and Stop Watch. Pediatric Balance Scale. Timepoint: Before and After the intervention for Upper Limb and lower limb in weight bearing and non weight bearing position. Method of measurement: Pediatric Balance Scale Questionnaire. MFT balance score. Timepoint: Before and After the intervention for Upper Limb and lower limb in weight bearing and non weight bearing position. Method of measurement: MFT Balance Disc 2.0. Jebsen-Taylor Hand Function Test. Timepoint: Before and After the intervention for Upper Limb and lower limb in weight bearing and non weight bearing position. Method of measurement: Writing a short sentence (24 letters, 3rd grade reading difficulty)Turning over a 3×5-inch card,Picking up small common objects (coins, paper clips and metal bottle caps) and transferring them into a container,Simulated feeding (by collecting beans with a spoon and transferring them into a container),Stacking checkers,Picking up and transferring large light objects (empty cans)Picking up and transferring large heavy objects (cans with weight of 0.453 kg). The subtests are scored by recording the number of seconds required to complete each test. Hand Grip Strength. Timepoint: Before and After the intervention for Upper Limb and lower limb in weight bearing and non weight bearing position. Method of measurement: Hand Held Digital Dynamometer. Joint Range of motion. Timepoint: Before and After the intervention for Upper Limb and lower limb in weight bearing and non weight bearing position. Method of measurement: Universal Goniometer. Cervical Joint Position Sense Error Test. Timepoint: Before and After the intervention for Upper Limb and lower limb in weight bearing and non weight bearing position. Method of measurement: Laser Tracker System. Center of Pressure of Both Feet. Timepoint: Before and After the intervention for Upper Limb and lower limb in weight bearing and non weight bearing position. Method of measurement: BWT-61 CL Digital Gyroscope. Shifa Tameer e Millat University Approved 2023-05-14 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)