Status:
UNKNOWN
Botulinum Toxin Type A and Kinesitherapy of Post-stroke Patients
Lead Sponsor:
Federal University of Bahia
Conditions:
Stroke
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The objective of this study is to assess if the association of botulinum toxin type A and kinesitherapy is superior to kinesitherapy and 0,9% saline for the functional performance in post-stroke patie...
Detailed Description
The patients will be oriented regarding to the study steps and potential risks of the procedures. They will be assessed by a spasticity-experienced physical therapist. Demographical data will be colle...
Eligibility Criteria
Inclusion
- Clinical diagnosis of cerebrovascular accident and indication for the botulinum toxin injection (Hypertonia equal or superior to 2 according to the Ashworth scale).
- Patients followed by the physical therapy staff at the IBR and HAS, with 2 appointments per week.
- Patients from both sexes with ages superior to 18 years
- To have the minimum of one a maximum of five years post post-stroke.
Exclusion
- Patients with age superior to 70 years
- Cognitive impairment
- Poorly controlled arterial hypertension
- Presence of joint blockade
- Unable to walk independently
- Use of orthesis as a gait aid
- Use of botulinum toxin within the last six months
- Use of systemic drugs for reduction of tonus
- Blood, liver, or kidney disorders and pregnant or lactating women
- Cardiopathy
- Comprehension aphasia
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00999180
Start Date
June 1 2009
End Date
April 1 2012
Last Update
December 15 2011
Active Locations (1)
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1
Federal University of Bahia
Salvador, Estado de Bahia, Brazil