NCT00999180

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 patients. Hypothesis H(0): BT-A associated to kinesitherapy is not superior to kinesitherapy in the function of hemiparetic post-stroke patients. H(1): BT-A associated to kinesitherapy is superior to kinesitherapy in the function of hemiparetic post-stroke patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for phase_3 stroke

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

December 15, 2011

Status Verified

October 1, 2009

Enrollment Period

2.8 years

First QC Date

October 20, 2009

Last Update Submit

December 14, 2011

Conditions

Stroke

Keywords

Botulinum ToxinRehabilitationStroke

Outcome Measures

Primary Outcomes (1)

  • Functional performance assessed by TUG test and six minutes walking: an improvement of more than 50% of the expected for each test.

    one year

Secondary Outcomes (1)

  • Muscle tone: a reduction of at least 1 point in the Ashworth scale. Range of movement: an improvement of at least 10 degrees.

    one year

Study Arms (2)

Btx-A and Kinesiotherapy

ACTIVE COMPARATOR

The botulinum toxin group will have the syringe filled with botulinum toxin type A (Dysport). During this period the patients will be followed by the IBR facility where will undergo a protocol of physical therapy comprising muscle strengthen, flexibility, endurance, and functional training.

Procedure: Botulinum toxin type A and kinesiotherapy

Saline and Kinesiotherapy

PLACEBO COMPARATOR

The control group will have the syringe filled with saline.During this period the patients will be followed by the IBR facility where will undergo a protocol of physical therapy comprising muscle strengthen, flexibility, endurance, and functional training.

Procedure: Saline and Kinesiotherapy

Interventions

Botulinum toxin type A and kinesiotherapyPROCEDURE

Stroke, Botulinum Toxin

Also known as: Dysport
Btx-A and Kinesiotherapy
Saline and KinesiotherapyPROCEDURE

Saline and Kinesiotherapy

Saline and Kinesiotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Bahia

Salvador, Estado de Bahia, Brazil

Location

MeSH Terms

Conditions

Stroke

Interventions

Botulinum Toxins, Type AabobotulinumtoxinASodium Chloride

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Ailton Melo, PHD

    Federal University of Bahia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Botulinum Toxin Type A and Kinesitherapy Use in the Functional Performance of Post-stroke Patients

Study Record Dates

First Submitted

October 20, 2009

First Posted

October 21, 2009

Study Start

June 1, 2009

Primary Completion

March 1, 2012

Study Completion

April 1, 2012

Last Updated

December 15, 2011

Record last verified: 2009-10

Locations

BR(1)