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

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400619
• Other study ID #: Neuroshockwaves
• Status: Completed
• Phase: Phase 1
• First received: March 6, 2015
• Last updated: March 9, 2017
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: University Ramon Llull
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Paralysis
• Spasticity

Intervention

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

Locations

Country	Name	City	State
Spain	Centro Piloto Arcangel Sant Gabriel. ASPACE	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Xavi Vidal Novellas	Cerebral Palsy Association

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	muscle elongation of spastic muscle will be evaluated using composite measure of muscular extensibility and their traction reflex with goniometry		up to three months
Secondary	Evaluate the patients perceive pain	It shall be assessed by visual analog scale	after each therapy
Secondary	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.		at the end to study
Secondary	To undergo a qualitative registration to know the perception and experience that patient/family will have during this study		at the end to study