Clinical trial NCT02400619: Shockwaves Therapy and Botulinum Toxin for the Treatment of Spasticity in Patients With Cerebral Palsy. A Cross Over RCT
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Spasticity
Cerebral Palsy
Keywords: shockwaves
Physiotherapy
Botulinum toxin
Lead sponsor: University Ramon Llull
Sponsor class: OTHER
Collaborators: name: Cerebral Palsy Association
First posted: 2015-03-27
Enrollment: 70
Sex: ALL
Minimum age (years): 5
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: muscle elongation of spastic muscle will be evaluated using composite measure of muscular extensibility and their traction reflex with goniometry
timeFrame: up to three months
Secondary outcomes:
measure: Evaluate the patients perceive pain
timeFrame: after each therapy
measure: 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.
timeFrame: at the end to study
measure: To undergo a qualitative registration to know the perception and experience that patient/family will have during this study
timeFrame: at the end to study
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Centro Piloto Arcangel Sant Gabriel. ASPACE
Study officials:
affiliation: Aspace. Association of Cerebral Palsy
name: Vidal Novellas
role: PRINCIPAL_INVESTIGATOR
References: