Centro Piloto Arcangel Sant Gabriel. ASPACE
Barcelona, 08320, Spain
NCT Number: NCT02400619
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
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Notify Me5 year–55 year
All sexes
Interventional
Phase 1
Barcelona, 08320, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
or genetic bone disorders / disturbances soft parts. Position with anomalies or alterations in soft parts or bone alterations (mechanical).
Swiss dolorclast smart EMS Registration: EN-60601-1 Type BF IP40. 93/42 CEE
Botulinum toxin type A Botox
Other names: Type A
Time frame: up to three months
Time frame: after each therapy
It shall be assessed by visual analog scale
Time frame: at the end to study
Time frame: at the end to study
Xavi Vidal Novellas
Other
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.
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