This study aimed to check and compare the effects of botulinum toxin injection combined with shock wave therapy versus botulinum toxin injection only for lower extremity spasticity in children with cerebral palsy
20 pediatric patients diagnosed with cerebral palsy who received botulinum toxin type A injection for lower extremity spasticity were divided into two groups. The first group will receive only conventional treatment after the injection, while the second group will receive extracorporeal shockwave therapy for injected muscles. The shock wave therapy is planned as 3 sessions per week, starting one week after the injection. Patients will be compared in terms of MAS scores, MTS scores, passive joint range of motion, modified timed up and go test, pain scores, (faces pain scale-revised) and Goal Attainment Scaling scores. Patients will be evaluated 1 week, 1 month and 3 months after the injection with pre-injection data.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
1500 pulses, 4 hertz, 2 bar radial extracorporeal shockwave therapy targeted muscle belly for botulinum toxin injected lower extremity muscle groups. 3 sessions were planned once a week, starting from first week after injection.
Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, Kadikoy, Turkey (Türkiye)
RECRUITINGModified Aschworth Scale
Scoring system used to evaluate spasticity. Spasticity scored as 0, 1, 1+, 2, 3, 4.
Time frame: 3 months (before injection, first week, first month and third month after injection.)
Modified Tradiue Scale
Scoring system used to evaluate spasticity. Spasticity scored as 0,1,2,3,4.
Time frame: 3 months (before injection, first week, first month and third month after injection.)
Modified Timed Up and Go Test
The test for evaluate the functionality of pediatric patients with cerebral palsy. Only one chair and a surface for the patient to walk three meters are required. The time it takes for the patient to get up from the chair, walk the specified distance and sit back in the chair is recorded.
Time frame: 3 months (before injection, first week, first month and third month after injection.
Facies Pain Scale Revised
The scale for evaluate the pain level of pediatric patients. Chosen faces are scored 0, 2, 4, 6, 8, or 10, counting left to right, so "0" equals "No pain" and "10" equals "Very much pain."
Time frame: 3 months (before injection, first week, first month and third month after injection.)
Passive Range of Motion
Goniometric measurement of the range of motion of the joint of the injected muscle
Time frame: 3 months (before injection, first week, first month and third month after injection.)
Goal Attaintment Scale
The method of scoring the extent to which patient's individual goals are achieved in the course of intervention. GAS comprises of goals divided into a 5-point scale from -2 to +2. Achievement of goal = 0 Achieved somewhat more than expected outcome = +1 Achievement of much more than expected goal = +2 Achievement of somewhat less than expected goal = -1 Achievement of much less than expected goal = -2
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Time frame: 3 months (before injection, first week, first month and third month after injection.)