The Effects of Botulinum Toxin Type a Injection Combined with RESWT in Lower Extremity Spasticity in Children with Cerebral Palsy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebral Palsy, Spastic
- Sponsor
- Istanbul Medeniyet University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Modified Aschworth Scale
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Bilinç Doğruöz Karatekin
Bilinc Dugruoz Karatekin, M.D., Department of Physical Medicine and Rehabilitation
Istanbul Medeniyet University
Eligibility Criteria
Inclusion Criteria
- •Diagnosed with cerebral palsy.
- •Spasticity in at least one of the lower extremity muscle groups.
- •No contraindications to shockwave therapy.
- •Applied Botulinum Toxin Type A injection for at least one spastic muscle of lower extremity.
- •Agreed to participate to study (patient/primary caregiver)
Exclusion Criteria
- •Surgery history within the last year of the muscle to be injected and treated
- •Having uncontrolled epilepsy.
- •Having infection
- •Coagulopathy
Outcomes
Primary Outcomes
Modified Aschworth Scale
Time Frame: 3 months (before injection, first week, first month and third month after injection.)
Scoring system used to evaluate spasticity. Spasticity scored as 0, 1, 1+, 2, 3, 4.
Modified Tradiue Scale
Time Frame: 3 months (before injection, first week, first month and third month after injection.)
Scoring system used to evaluate spasticity. Spasticity scored as 0,1,2,3,4.
Modified Timed Up and Go Test
Time Frame: 3 months (before injection, first week, first month and third month after injection.
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.
Facies Pain Scale Revised
Time Frame: 3 months (before injection, first week, first month and third month after injection.)
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."
Passive Range of Motion
Time Frame: 3 months (before injection, first week, first month and third month after injection.)
Goniometric measurement of the range of motion of the joint of the injected muscle
Goal Attaintment Scale
Time Frame: 3 months (before injection, first week, first month and third month after injection.)
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