Botox injection in 1st toe to treat spasticity

Phase 1

Active, not recruiting

• Conditions: 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.; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2020-005653-24-ES
• Lead Sponsor: Clínica Integral del pie-Ana Sans

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-14
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>Returning to perform the tests and ranges of movement, to assess quantitatively.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): PATIENT ASSESSMENT TEST, SPECIFIC OBJECTIVES OF THE INFILTRATION:<br>1-Improve activities of daily living mainly hygiene tasks yes / no<br>2-Improve functionality yes / no<br>3-Reduce pain yes / no<br>4-Adaptation of orthotic aids yes / no<br>5-Allow a better adaptation in the sitting position yes / no<br>6-Reduce the number of spasms yes / no<br>7-Improve joint range yes / no<br>8-Improve gait pattern yes / no<br>9-Prevent the appearance of contractures and muscle shortening yes / no<br>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<br> Neurological test<br>Romberg test<br>Biomechanical study of gait<br><br>Balance<br>Claudication or limb paresis<br>Tandem gait<br>Toe or heel gait<br>Astasia-Abasia<br>Taboo march<br><br>Observations<br>Clinical report and consultation sheet, if applicable.