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
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: 1. Modified Ashworth scale for muscle tone. 2. Goniometer for Ankle ROM. 3. EMed force platform for plantar surface area 4. Gross motor function scale for gross motor function 5. Cerebral Palsy Quality of Life Questionnaire for quality of life assessment
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
70
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.
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
King Salman Hospital
Hail, Saudi Arabia
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at follow up (3months after the end of the treatment)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: at follow up (3months after the end of the treatment)
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.
Time frame: 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.
Time frame: 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.
Time frame: at follow up (3months after the end of the treatment)