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IRCT20200215046504N1 IRCT 2020-07-29 Prince Sattam bin Abdulaziz University/Deanship of Scientific Research Neuromuscular blocking/stimulation in cerebral palsy Functional Outcomes of Botulinum Neurotoxin-A Injection Followed by Reciprocal Electrical Stimulation of Upper-Limb Muscles in Children with Cerebral Palsy 2018-08-01 anticipated 56 Complete https://irct.ir/trial/49144 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: - Stratified randomization will be used - First, Four strata will be constructed based on participants' age and spasticity level on the Modified Ashworth scale (MAS) as follows: 1- Children ages 6 to 8 and have spasticity level II on MAS 2- Children ages more than 8 to 10 years and have spasticity level II on MAS 3- Children ages 6 to 8 and have spasticity level III on MAS 4- Children ages more than 8 to 10 years and have spasticity level III on MAS - Next, the subjects in each stratum will be concealed in black envelopes. - Then, a random sample, proportional to the stratum size, will be selected by an independent person who will not be a part of the study (physical therapy student) to create four subsamples from each stratum. - Eventually, four subsamples (one from each stratum) will be selected rondomly by the same independent person and will be compiled to form a sample for each group, Blinding description: The rater will be blinded to intervention assignments and will not be part of this research at any stage of its implementation. N/A Cerebral palsy. Intervention 1: Intervention group: 1) Children will receive a single set of intramuscular injection of botulinum toxin-A (Botox®, Allergan PLC, Dublin, Ireland). To increase injection tolerance, children will be sedated using oral midazolam (0.5 mg/kg). The dosage will be 0.5-2 U kg-1/muscle group, with a total dosage of 12 U kg-1 (and will never exceed a maximum total dose of 400 U). An ultrasound-guided injection procedure will be used to determine the locations of injection. 2) Children will receive a physical rehabilitation program emphasizing functional strength training, hand weight-bearing exercises, stretching exercises, and bilateral-arm and inter-arm coordination exercises. The program will be administered in three 60-minute sessions/week over three consecutive months by three pediatric rehabilitation specialists. Intervention 2: Intervention group: 1) Children will receive three 15-minute reciprocal electrical stimulation per week for three successive months. A computerized electrical stimulator (Vectra®2C; Chattanooga, TS, USA) with a dual-channel stimulating unit will be used, each channel has two small-size, rectangular carbon rubber electrodes (3x5 cm), which will be enclosed in two spongy covers. Channel 1 will be applied to wrist and finger flexors while channel 2 will be applied to wrist and finger extensors. Simulation parameters will be: symmetrical biphasic square waveform, frequency of 30 Hz, a pulse width of 300 μs, the up- and down-ramp times will be set on an individual basis to avoid the stretch-reflex from becoming elicited, alternating cyclic time (wrist 5 seconds for flexors and 10 seconds for extensors), the intensity will be adjusted to the sensory threshold to acclimate the children to the stimulation and will then be increased until visible contraction will be achieved. 2) children will receive a physical rehabilitation program emphasizing functional strength training, hand weight-bearing exercises, stretching exercises, and bilateral-arm and inter-arm coordination exercises. The program will be administered in three 60-minute sessions/week over three consecutive months by three pediatric rehabilitation specialists. Intervention 3: Intervention group: 1) Will receive a single set of intramuscular injection of botulinum toxin-A (Botox®, Allergan PLC, Dublin, Ireland). To increase injection tolerance, children will be sedated using oral midazolam (0.5 mg/kg). The dosage will be 0.5-2 U kg-1/muscle group, with a total dosage of 12 U kg-1 (and will never exceed a maximum total dose of 400 U). An ultrasound-guided injection procedure will be used to determine the locations of injection. 2) Children will receive three 15-minute reciprocal electrical stimulation per week for three successive months. A computerized electrical stimulator (Vectra®2C; Chattanooga, TS, USA) with a dual-channel stimulating unit will be used, each channel has two small-size, rectangular carbon rubber electrodes (3x5 cm), which will be enclosed in two spongy covers. Channel 1 will be applied to wrist and finger flexors while channel 2 will be applied to wrist and finger extensors. Simulation parameters will be: symmetrical biphasic square waveform, frequency of 30 Hz, a pulse width of 300 μs, the up- and down-ramp times will be set on an individual basis to avoid the stretch-reflex from becoming elicited, alternating cyclic time (wrist 5 seconds for flexors and 10 seconds for extensors), the intensity will be adjusted to the sensory threshold to acclimate the children to the stimulation and will then be increased until visible contraction will be achieved. 3) children will receive a physical rehabilitation program emphasizing functional strength training, hand weight-bearing exercises, stretching exercises, and bilateral-arm and inter-arm coordination exercises. The program will be administered in three 60-minute sessions/week over three consecutive months by three pediatric rehabilitation specialists. Intervention 4: Intervention group: 1) children will receive a physical rehabilitation program emphasizing functional strength training, hand weight-bearing exercises, stretching exercises, and bilateral-arm and inter-arm coordination exercises. The program will be administered in three 60-minute sessions/week over three consecutive months by three pediatric rehabilitation specialists. 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 Data could be shared on a reasonable request
public Ragab Kamal Elnaggar
Sa'ad Ibn Mu'adh
Al-Kharj Saudi Arabia 16278 +966 11 588 6321 rke_pt2001@yahoo.com Prince Sattam bin Abdulaziz University scientific Ragab Kamal Elnaggar
Sa'ad Ibn Mu'adh
Al-Kharj Saudi Arabia 16278 +966 11 588 6321 rke_pt2001@yahoo.com Prince Sattam bin Abdulaziz University Saudi Arabia Diagnosis of spastic hemiplegic cerebral palsy age between 6 and 10 years Spasticity grade II or III according to Modified Ashworth Scale mental capacity enabling compliance with evaluation and treatment instructions Normal/corrected visual and auditory function 6 years 10 years Both Contractures limiting arm-hand function Botulinum toxin-A injection in the involved upper limb in the past six months If children will be advised against stopping spasticity-relieving medications during the study period by their neuro-pediatrician Orthopedic or neuromuscular surgery or casting of the paretic upper limb within 1 year before starting study Uncontrolled seizures G80 Cerebral palsy Rehabilitation Rehabilitation Rehabilitation Rehabilitation Intervention group: 1) Children will receive a single set of intramuscular injection of botulinum toxin-A (Botox®, Allergan PLC, Dublin, Ireland). To increase injection tolerance, children will be sedated using oral midazolam (0.5 mg/kg). The dosage will be 0.5-2 U kg-1/muscle group, with a total dosage of 12 U kg-1 (and will never exceed a maximum total dose of 400 U). An ultrasound-guided injection procedure will be used to determine the locations of injection. 2) Children will receive a physical rehabilitation program emphasizing functional strength training, hand weight-bearing exercises, stretching exercises, and bilateral-arm and inter-arm coordination exercises. The program will be administered in three 60-minute sessions/week over three consecutive months by three pediatric rehabilitation specialists. Intervention group: 1) Children will receive three 15-minute reciprocal electrical stimulation per week for three successive months. A computerized electrical stimulator (Vectra®2C; Chattanooga, TS, USA) with a dual-channel stimulating unit will be used, each channel has two small-size, rectangular carbon rubber electrodes (3x5 cm), which will be enclosed in two spongy covers. Channel 1 will be applied to wrist and finger flexors while channel 2 will be applied to wrist and finger extensors. Simulation parameters will be: symmetrical biphasic square waveform, frequency of 30 Hz, a pulse width of 300 μs, the up- and down-ramp times will be set on an individual basis to avoid the stretch-reflex from becoming elicited, alternating cyclic time (wrist 5 seconds for flexors and 10 seconds for extensors), the intensity will be adjusted to the sensory threshold to acclimate the children to the stimulation and will then be increased until visible contraction will be achieved. 2) children will receive a physical rehabilitation program emphasizing functional strength training, hand weight-bearing exercises, stretching exercises, and bilateral-arm and inter-arm coordination exercises. The program will be administered in three 60-minute sessions/week over three consecutive months by three pediatric rehabilitation specialists. Intervention group: 1) Will receive a single set of intramuscular injection of botulinum toxin-A (Botox®, Allergan PLC, Dublin, Ireland). To increase injection tolerance, children will be sedated using oral midazolam (0.5 mg/kg). The dosage will be 0.5-2 U kg-1/muscle group, with a total dosage of 12 U kg-1 (and will never exceed a maximum total dose of 400 U). An ultrasound-guided injection procedure will be used to determine the locations of injection. 2) Children will receive three 15-minute reciprocal electrical stimulation per week for three successive months. A computerized electrical stimulator (Vectra®2C; Chattanooga, TS, USA) with a dual-channel stimulating unit will be used, each channel has two small-size, rectangular carbon rubber electrodes (3x5 cm), which will be enclosed in two spongy covers. Channel 1 will be applied to wrist and finger flexors while channel 2 will be applied to wrist and finger extensors. Simulation parameters will be: symmetrical biphasic square waveform, frequency of 30 Hz, a pulse width of 300 μs, the up- and down-ramp times will be set on an individual basis to avoid the stretch-reflex from becoming elicited, alternating cyclic time (wrist 5 seconds for flexors and 10 seconds for extensors), the intensity will be adjusted to the sensory threshold to acclimate the children to the stimulation and will then be increased until visible contraction will be achieved. 3) children will receive a physical rehabilitation program emphasizing functional strength training, hand weight-bearing exercises, stretching exercises, and bilateral-arm and inter-arm coordination exercises. The program will be administered in three 60-minute sessions/week over three consecutive months by three pediatric rehabilitation specialists. Intervention group: 1) children will receive a physical rehabilitation program emphasizing functional strength training, hand weight-bearing exercises, stretching exercises, and bilateral-arm and inter-arm coordination exercises. The program will be administered in three 60-minute sessions/week over three consecutive months by three pediatric rehabilitation specialists Unilateral upper-limb function. Timepoint: Pre-treatment, post-treatment, and 6 months after treatment (all completed). Method of measurement: Melbourne Assessment. Bimanual hand function. Timepoint: Pre-treatment, post-treatment, and 6 months after treatment (all completed). Method of measurement: Assisting Hand Assessment. Arm-hand, real-time function. Timepoint: Pre-treatment, Post-treatment, and 6 months post-treatment (all completed). Method of measurement: Pediatric Motor Activity Log. Prince Sattam bin Abdulaziz University/Deanship of Scientific Research Approved 2018-05-23 Department of Physical Therapy Research Ethics Committee Sa'ad Ibn Mu'adh Al-Kharj Riyadh Saudi Arabia