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Completed

NCT Number: NCT02400619

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

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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Key information

Age range

5 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Centro Piloto Arcangel Sant Gabriel. ASPACE

Barcelona, 08320, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 5 and 55 years
  • Any level of GMFCS (Gross Motor Function Classification System)
  • The patient consent to participate in the study
  • Diagnosis of spastic cerebral palsy
  • Triceps Surae spasticity in them.
  • The dynamic foot deformity.
  • Extensibility between 0 ° and 20 ° in dorsal flexion passive way.
  • Do not be diagnosed important cutaneous alterations.

Exclusion criteria

  • Associate neuromuscular disease.
  • Surgical Intervention to augment the balance articulate and / or reduce the spasticity in the last six months.
  • Fixed foot deformity.
  • Etiology of factors:

or genetic bone disorders / disturbances soft parts. Position with anomalies or alterations in soft parts or bone alterations (mechanical).

  • Unable to follow the treatment.
  • Allergy to botulinum toxin.

Treatment and study plan

Shock waves

Device

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

Botulinum Toxin Type A

Drug

Botulinum toxin type A Botox

Other names: Type A

Primary outcomes

  1. muscle elongation of spastic muscle will be evaluated using composite measure of muscular extensibility and their traction reflex with goniometry

    Time frame: up to three months

Secondary outcomes

  1. Evaluate the patients perceive pain

    Time frame: after each therapy

    It shall be assessed by visual analog scale

  2. Ascertain if the type of GMFCS has an influence on the improvement of these two treatments. Qualitative registation to achieve the percepcion and experience that have made the treatment received the patient/family.

    Time frame: at the end to study

  3. To undergo a qualitative registration to know the perception and experience that patient/family will have during this study

    Time frame: at the end to study

Sponsors and collaborators

Lead sponsor

Xavi Vidal Novellas

Other

Collaborators

  • Cerebral Palsy Association

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 27, 2015
Registry last updated
Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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