Cerebral Palsy, Spasticity
Conditions
Keywords
shockwaves, Physiotherapy, Botulinum toxin
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.
Interventions
DEVICEshock waves
Swiss dolorclast smart EMS Registration: EN-60601-1 Type BF IP40. 93/42 CEE
DRUGBotulinum Toxin Type A
Botulinum toxin type A Botox
Sponsors
Cerebral Palsy Association
Xavi Vidal Novellas
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the patients perceive pain | after each therapy | It shall be assessed by visual analog scale |
| 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 | — |
Countries
Spain
Outcome results
None listed