Effect of Radial Shockwave on Calf Muscle Spasticity in Patients With Cerebral Palsy

Study Overview
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Brief Summary
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the aim of this study to assess different outcome measures after applying standard physical therapy plus radial shockwave and compare the results with another group who received standard treatment only. Design: double-blinded (assessor and data analyzer) Methods: This study will be conducted in 4 rehabilitation facilities, Times for 1 month of intervention Assessment timeline: 3 times (T0: at baseline, T1: at 4 weeks, T2: follow up at 3 months. Outcome measures: the Modified Ashworth scale (MAS), Ankle ROM, Plantar surface area, Gross motor function, and quality of life

Detailed Description
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the current study is a randomized controlled trial in which the researchers intended to examine the effect of adding radial shockwave therapy to standard physical therapy on the status of calf muscle spasticity and consequent effects on gross motor function, ankle joint ROM, plantar surface area, and quality of life. the experimental intervention will consist of 4 sessions of radial shockwave applied to the bulkiest area of the calf muscle in children having spastic cerebral palsy. participants will receive 1 session of radial shockwave per week and will continue their regular physical therapy as usual (3 sessions per week). outcome assessment will be conducted 3 times: at baseline, after the end of the treatment program, and at 3 months follow-up. the tools that will be used to collect data will be: Modified Ashworth scale for muscle tone. Goniometer for Ankle ROM. EMed force platform for plantar surface area Gross motor function scale for gross motor function Cerebral Palsy Quality of Life Questionnaire for quality of life assessment

Official Title
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Effect of Radial Shock Wave Therapy on Calf Muscle Tone, ROM, Gross Motor Scale, Plantar Surface and Quality of Life in Patients With Cerebral Palsy: Randomized Controlled Trial

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Other: Experimental Interventions
* Other: Standard physical therapy program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 8-14 diagnosed with spastic CP ability to walk alone or with assistance grades 1 -4 on Gross Motor Function Classification System at least score 1 on the Modified Ashworth Scale (MAS) ability to attend the treatment program and the outcome assessment sessions. Exclusion Criteria: patients who received a botulinum toxin injection in the calf muscle during the last six months structural contracture of the calf muscle surgery in the lower extremity during the previous year those experiencing pain in the lower limbs severe associated neurological diseases as epilepsy medications affecting peripheral muscle tone.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Standard physical therapy program<br>all participants will receive strengthing, stretching, facilitation and inhibitory techniques, splinting, developmental techniques, gait, and balance training. The duration of each session will be 1 hour, 3 times per week for 4 weeks. | Other: Standard physical therapy program<br>* Regular rehabilitation procedures consist of strengthing, stretching, facilitation and inhibitory techniques, splinting, developmental techniques, gait and balance training, and advice to parents. The duration of each session will be 1 hour, 3 times per week for 4 weeks<br>* Other names: Standard physical therapy intervention;|
| Active Comparator: Radial shockwave therapy (rSWT)<br>One session per week of rSWT will be applied using shockwave device. The following parameters will be used: Shocks number: 1500 per muscle, will be applied over the belly of the calf muscle using the 15 mm applicator head. The pressure will be 2 bar and the frequency will be 4 Hz. Patients will receive shock wave from prone position. | Other: Experimental Interventions<br>* One session per week of rSWT will be applied using the BMI-1120 SHOCK MED device (BIO-MED-INC- ITALY). The following parameters will be used: Shocks number: 1500 per muscle, will be applied over the belly of the calf muscle using the 15 mm applicator head. The pressure will be 2 bar and the frequency will be 4 Hz. Patients will receive shock wave from prone position.<br>* Other names: Radial shock wave therapy (rSWT);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| calf muscle tone | the Modified Ashworth scale (MAS) will be used to assess the tone of the affected calf muscle. the test will be done by moving the ankle joint passively and assess quality of movement and resistance provided by the tissues. scores ranged from 0 to 4 where 0 means normal and 4 means higher spasticity | at baseline | 
| calf muscle tone | the Modified Ashworth scale (MAS) will be used to assess the tone of the affected calf muscle. the test will be done by moving the ankle joint passively and assess quality of movement and resistance provided by the tissues. scores ranged from 0 to 4 where 0 means normal and 4 means higher spasticity | at 4 weeks | 
| calf muscle tone | the Modified Ashworth scale (MAS) will be used to assess the tone of the affected calf muscle. the test will be done by moving the ankle joint passively and assess quality of movement and resistance provided by the tissues. scores ranged from 0 to 4 where 0 means normal and 4 means higher spasticity | at follow up (3months after the end of the treatment) | 
| ankle joint ROM | traditional goniometer will be used to measure active ROM of the ankle joint. the patient will be in supine position during assessment | at baseline | 
| ankle joint ROM | traditional goniometer will be used to measure active ROM of the ankle joint. the patient will be in supine position during assessment | at 4 weeks | 
| ankle joint ROM | traditional goniometer will be used to measure active ROM of the ankle joint. the patient will be in supine position during assessment | at follow up (3months after the end of the treatment) | 
| plantar surface area | E Med force platform will be used to assess plantar surface area during normal relaxed standing. it will be expected that larger surface area indicate improvement in calf muscle spasticity | at baseline | 
| plantar surface area | E Med force platform will be used to assess plantar surface area during normal relaxed standing. it will be expected that larger surface area indicate improvement in calf muscle spasticity | at 4 weeks | 
| plantar surface area | E Med force platform will be used to assess plantar surface area during normal relaxed standing. it will be expected that larger surface area indicate improvement in calf muscle spasticity | at follow up (3months after the end of the treatment) | 
| gross-motor function | Gross Motor Function Measure scale will be used to assess changes in gross motor. function in cerebral palsy patients. the score will be determined according to the tasks the patient can do. where lower score (1) for nealy normal patients while score of (5) will indicate lowest gross motor abilities. | at baseline | 
| gross-motor function | Gross Motor Function Measure scale will be used to assess changes in gross motor. function in cerebral palsy patients. the score will be determined according to the tasks the patient can do. where lower score (1) for nealy normal patients while score of (5) will indicate lowest gross motor abilities. | at 4 weeks | 
| gross-motor function | Gross Motor Function Measure scale will be used to assess changes in gross motor. function in cerebral palsy patients. the score will be determined according to the tasks the patient can do. where lower score (1) for nealy normal patients while score of (5) will indicate lowest gross motor abilities. | at follow up (3months after the end of the treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cerebral palsy quality of life questionnaire | Parents will be asked to report their level of quality of life using the Cerebral Palsy Qualityof life questionnair. the higher the gained score the better the quality of life achieved. | at baseline | 
| cerebral palsy quality of life questionnaire | Parents will be asked to report their level of quality of life using the Cerebral Palsy Qualityof life questionnair. the higher the gained score the better the quality of life achieved. | at 4 weeks | 
| cerebral palsy quality of life questionnaire | Parents will be asked to report their level of quality of life using the Cerebral Palsy Qualityof life questionnair. the higher the gained score the better the quality of life achieved. | at follow up (3months after the end of the treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radial shockwave therapy, muscle tone, ROM, gross motor scale, quality of life