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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum Toxin Injection and Conventional Therapy | No Intervention | The group received conventional therapy (such as stretching exercises) after Botulinum Toxin Type A Injection for spastic lower extremity muscle groups. | |
| Botulinum Toxin Injection and Shockwave Therapy | Active Comparator | The group received extracorporeal shockwave therapy conventional therapy (such as stretching exercises). Shockwave therapy is planned 3 sessions, starting first week after injection. It is planned to apply 1500 pulses, 4 hertz, 2 bars radial eswt to the injected spastic muscle groups in each session. The patients in this group will continue to their conventional therapy like the first group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radial Extracorporeal Shockwave Therapy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Aschworth Scale | Scoring system used to evaluate spasticity. Spasticity scored as 0, 1, 1+, 2, 3, 4. | 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. | 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. | 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." | 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 | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ismail Hakan Akbulut, Resident | Contact | +905549151240 | hakan__akbulut@hotmail.com | |
| Belgin Erhan, Assoc. Prof. | Contact | +905322678024 | dr.belginerhan@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Belgin Erhan, Assoc. Prof. | Istanbul Medeniyet University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul Medeniyet University Goztepe Prof. Dr. Suleyman Yalcin City Hospital | Recruiting | Istanbul | Kadikoy | 34722 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Pediatric patients diagnosed with cerebral palsy who received botulinum toxin injection for lower extremity spasticity were randomized 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 and their routine conventional therapy. The shock wave therapy is planned as 3 sessions per week, starting one week after the injection.
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Outcomes Assessor were blinded to patients who received shockwave therapy and who did not received.
| 3 months (before injection, first week, first month and third month after injection.) |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |