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

NCT ID: NCT02400619

Last Updated: 2017-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-12-31

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.

Conditions

Spasticity; Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

shock waves

A comparative study with patients with spasticity in gastrocnemius and soleus where a group start having shockwave treatment and receive three sessions at weekly intervals, gastrocnemius and soleus applied in 2000 impacts at a frequency of 8hz and energy intensity is proposed between 2.2-2.4 Bars (0,10-0,12mj ). Swiss dolor clast EMS. The other group will receive botulinum toxin Type A in the same muscles. The dose of toxin is in accordance with the weight of each patient, the dose normally used with each user and always with the same brand is always respected, Botox (4-8-12 U/Kg) Patients will be assessed before treatment, after three weeks, two months and three months after three months when the groups exchange the therapy.

Group Type: ACTIVE_COMPARATOR

shock waves

Intervention Type: DEVICE

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

botulinum toxin

A comparative study with patients with spasticity in gastrocnemius and soleus where a group start having shockwave treatment and receive three sessions at weekly intervals, gastrocnemius and soleus applied in 2000 impacts at a frequency of 8hz and energy intensity is proposed between 2.2-2.4 Bars (0,10-0,12mj ). Swiss dolor clast EMS.The other group will receive botulinum toxin type A in the same muscles. The dose of toxin is in accordance with the weight of each patient, the dose normally used with each user and always with the same brand is always respected. Botox (4-8-12 U/Kg)Patients will be assessed before treatment, after three weeks, two months and three months after three months when the groups exchange the therapy.

Group Type: ACTIVE_COMPARATOR

Botulinum Toxin Type A

Intervention Type: DRUG

Botulinum toxin type A Botox

Interventions

shock waves

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

Intervention Type: DEVICE

Botulinum Toxin Type A

Botulinum toxin type A Botox

Intervention Type: DRUG

Other Intervention Names

Type A

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cerebral Palsy Association

OTHER

Sponsor Role: collaborator

Xavi Vidal Novellas

OTHER

Sponsor Role: lead

Responsible Party

Xavi Vidal Novellas

Xavi Vidal Novellas Health Sciences Faculty Blanquerna and physical therapist in Aspace Association of Cerebral Palsy

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Vidal Novellas

Role: PRINCIPAL_INVESTIGATOR

Aspace. Association of Cerebral Palsy

Locations

Centro Piloto Arcangel Sant Gabriel. ASPACE

Barcelona, Barcelona, Spain

Countries

Spain

Other Identifiers

Neuroshockwaves

Identifier Type: -

Identifier Source: org_study_id