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

NCT02400619 | Completed Phase 1

• 1 other identifier: Neuroshockwaves
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Spasticity; Cerebral Palsy

Keywords

shockwaves; Physiotherapy; Botulinum toxin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluate the patients perceive pain

  after each therapy

• 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

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

  at the end to study

Study Arms (2)

shock waves

ACTIVE COMPARATOR

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.

Device: shock waves

botulinum toxin

ACTIVE COMPARATOR

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.

Drug: Botulinum Toxin Type A

Interventions

shock waves DEVICE

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

shock waves

Botulinum Toxin Type A DRUG

Botulinum toxin type A Botox

Also known as: Type A

botulinum toxin

Eligibility Criteria

• Age: 5 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xavi Vidal Novellas: lead
• Cerebral Palsy Association: collaborator

Study Sites (1)

Centro Piloto Arcangel Sant Gabriel. ASPACE

Barcelona, Barcelona, 08320, Spain

Location

MeSH Terms

Conditions

Muscle Spasticity; Cerebral Palsy

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Vidal Novellas

  Aspace. Association of Cerebral Palsy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Xavi Vidal Novellas Health Sciences Faculty Blanquerna and physical therapist in Aspace Association of Cerebral Palsy

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: March 27, 2015
• Study Start: September 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2016
• Last Updated: March 13, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)