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

NCT02400619 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-03-13

No results posted yet for this study

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

Conditions

  • Spasticity
  • Cerebral Palsy

Interventions

DEVICE

shock waves

Swiss dolorclast smart EMS Registration: EN-60601-1 Type BF IP40. 93/42 CEE

DRUG

Botulinum Toxin Type A

Botulinum toxin type A Botox

Sponsors & Collaborators

  • Cerebral Palsy Association

    collaborator OTHER

  • Xavi Vidal Novellas

    lead OTHER

Principal Investigators

  • Vidal Novellas · Aspace. Association of Cerebral Palsy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-06-30
Completion
2016-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02400619 on ClinicalTrials.gov