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The Effect and safety of Botox in the treatment of patients with Spinal injury associated with Human T-cell Lymphotrofic Virus type I

Efficacy and safety of Botulinum Toxin in the treatment of spasticity in patients with Tropical spastic paraparesis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-67ynvt
Enrollment
Unknown
Registered
2020-02-20
Start date
2018-06-14
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human T lymphotropic virus 1

Interventions

40 individuals will be recruited. All research participants will be treated with physiotherapy and will receive baclofen tablets (daily use of 3 10mg tablets for three months). They will be divided in
Drug
Biological/vaccine
Other

Sponsors

Hospital Universitário Professor Edgard Santos
Lead Sponsor
Hospital Universitário Professor Edgard Santos
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Individuals over 18 years old; both sexes; diagnosed with tropical spastic paraparesis, confirmed with Elisa and Western Blot tests; who have not used botulinum toxin to treat spasticity

Exclusion criteria

Exclusion criteria: individuals who are pregnant; bleeding disorders; with an infectious skin lesion at the injection site; other neurological diseases

Design outcomes

Primary

MeasureTime frame
Spasticity, assessed by the Modified Ashworth Scale before and after 12 weeks of intervention

Secondary

MeasureTime frame
Functionality, assessed by the Functional Independence Measure before and after 12 weeks of intervention;Quality of life, assessed by the Short Form Health Survey (SF-36) before and after 12 weeks of intervention;Gait speed, assessed using the 10-meter walk test before and after 12 weeks of intervention;Functional mobility, assessed using the Timed Up and Go Test (TUG) before and after 12 weeks of intervention;Muscle strength of lower limbs will be assessed by the five repetition sit / stand test before and after 12 weeks of intervention;Pain intensity and location, assessed by the Visual Analogue Scale and the Michigan Body Map, respectively, before and after 12 weeks of intervention;Activity and social participation, assessed by the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 before and after 12 weeks of intervention

Countries

Brazil

Contacts

Public ContactAilton Melo

Hospital Universitário Professor Edgard Santos

asm@ufba.br+55-71-9975-5275

Outcome results

None listed

Source: REBEC (via WHO ICTRP)