Cerebral Palsy Clinical Trial
Official title:
Efficacy of Radial Extracorporeal Shock Waves Compared to Botulinum Toxin Type A in the Treatment of Spasticity of the Lower Extremities in Patients With Cerebral Palsy: a Crossover Randomized Clinical Trial.
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
Outcome Measures:
The primary outcome will be to measure spasticity with passive range of motion of the foot
(pROM) by muscular extensibility and its traction reflex using goniometryIt will be assessed
at baseline before the treatment, as well as after 3 weeks, 2 months, 3 months, after the
washout period (3months), 3 months and 3 weeks, 5 months and 6 months, when the end the
intervention.
Secondary outcome includes: 1) Pain will be assessed with Visual Analog Scale (VAS) after
the first application of each therapy. 2) Ascertain if the type of Gross Motor Functional
Classification System (GMFCS) has an influence on the improvement of these two treatments;
3) Assess whether infiltration of Botulinum Toxin in other muscle groups have influence on
the results of study; and 4) Undergo a qualitative registration to know the perception and
experience that patient/family will have during this study, through a satisfaction
questionnaire.
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