drugset / Trial / NCT02400619

Shockwaves Therapy and Botulinum Toxin for the Treatment of Spasticity in Patients With Cerebral Palsy. A Cross Over RCT

NCT02400619

RandomizedCrossoverSingle-blindTreatment

Summary

Spasticity is a motor disorder that can affect the lower limbs in up to 75% patients with cerebral palsy, having a significantly effect on their mobility and quality of life. There is much controversy about what is the most appropriate treatment of spasticity The objective of the present study is to evaluate the effects of radial extracorporeal shock wave therapy (rESWT) compared to treatment with botulinum toxin to improve spasticity in patients with cerebral palsy The number needed of patients is 70 (35 per group). Leaving a period of washout between one therapy and the other

Timeline

Start
2014-09
Primary completion
2015-06
Completion
2016-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Botulinum toxin type A Protein / enzyme biologic 4 iu/kg
Comparator Botulinum toxin type A Protein / enzyme biologic 8 iu/kg
Comparator Botulinum toxin type A Protein / enzyme biologic 12 iu/kg

Indications