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| Name | Class |
|---|---|
| Cerebral Palsy Association | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| shock waves | Device | Swiss dolorclast smart EMS Registration: EN-60601-1 Type BF IP40. 93/42 CEE |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the patients perceive pain | It shall be assessed by visual analog scale | 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. |
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Inclusion Criteria:
Exclusion Criteria:
or genetic bone disorders / disturbances soft parts. Position with anomalies or alterations in soft parts or bone alterations (mechanical).
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| Name | Affiliation | Role |
|---|---|---|
| Vidal Novellas | Aspace. Association of Cerebral Palsy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Piloto Arcangel Sant Gabriel. ASPACE | Barcelona | Barcelona | 08320 | Spain |
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| ID | Term |
|---|---|
| D009128 | Muscle Spasticity |
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Botulinum Toxin Type A | Drug | Botulinum toxin type A Botox |
|
|
| 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 |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |