The application of Botox is described in the technical sheet for spasticity and has already been applied to the foot. This is how we speak of a phase IV clinical trial, with a low level of intervention.
Conditions
Interventions
Trade Name: Botox 50
Product Name: BOTOX 50U ALLERGAN
Product Code: SUB13117MIG
Pharmaceutical Form: Powder for injection
INN or Proposed INN: Clostridium botulinum
Other descriptive name: BOTULINUM T
Sponsors
Clínica Integral del pie-Ana Sans
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Neurological patients aged 18 to 80 years Patients with stroke, parkinson's or multiple sclerosis, who present spasticity of the 1st toe. Spasticity of the 1st toe, pain and gait instability. Hyperextension of the 1st finger, causing inability to put on shoes, in neurological patients. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Skin ulcers In pregnancy and lactation the use is contraindicated. Minor patients and those patients who do not have the authorization of a family member or guardian. Individuals with known hypersensitivity to botulinum toxin type A or to any of the excipients of the formulation. In case of infection at the proposed injection site (s). Eaton Lambert Syndrome patients. Patients with severe dysphagia or respiratory compromise. Patients with myasthenia gravis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of botulinum toxin infiltration treatment for 1st toe spasticity in neurological patients.;Secondary Objective: Assess the improvement in functionality, gait stability and analgesic effect.;Primary end point(s): The main variable is that the study subjects will be randomized so that this provides statistical power. Two possible treatment concentrations 25U or 50U will be applied, assigned to each of the groups, in a single application. Never exceed with this dose, what is allowed according to the drug's technical data sheet.;Timepoint(s) of evaluation of this end point: A control visit will be made a month, and thus assess the therapeutic effects achieved. Returning to perform the tests and ranges of movement, to assess quantitatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PATIENT ASSESSMENT TEST, SPECIFIC OBJECTIVES OF THE INFILTRATION: 1-Improve activities of daily living mainly hygiene tasks yes / no 2-Improve functionality yes / no 3-Reduce pain yes / no 4-Adaptation of orthotic aids yes / no 5-Allow a better adaptation in the sitting position yes / no 6-Reduce the number of spasms yes / no 7-Improve joint range yes / no 8-Improve gait pattern yes / no 9-Prevent the appearance of contractures and muscle shortening yes / no 10-Prevent deformities or orthopedic alterations: scoliosis, subluxation or dislocation of the hip and clubfoot ankle dysplasia yes / no;Timepoint(s) of evaluation of this end point: Will be made Neurological test Romberg test Biomechanical study of gait Balance Claudication or limb paresis Tandem gait Toe or heel gait Astasia-Abasia Taboo march Observations Clinical report and consultation sheet, if applicable. | — |
Countries
Spain
Contacts
Public ContactAna Sans
Clínica integral del pie-Ana Sans
Outcome results
None listed