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Botulinum Toxin Type A and Kinesitherapy of Post-stroke Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Ailton de Souza Melo, Federal University of Bahia.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00999180
First Posted: October 21, 2009
Last Update Posted: December 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ailton de Souza Melo, Federal University of Bahia
  Purpose

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.


Condition Intervention Phase
Stroke Procedure: Botulinum toxin type A and kinesiotherapy Procedure: Saline and Kinesiotherapy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Botulinum Toxin Type A and Kinesitherapy Use in the Functional Performance of Post-stroke Patients

Resource links provided by NLM:


Further study details as provided by Ailton de Souza Melo, Federal University of Bahia:

Primary Outcome Measures:
  • Functional performance assessed by TUG test and six minutes walking: an improvement of more than 50% of the expected for each test. [ Time Frame: one year ]

Secondary Outcome Measures:
  • Muscle tone: a reduction of at least 1 point in the Ashworth scale. Range of movement: an improvement of at least 10 degrees. [ Time Frame: one year ]

Estimated Enrollment: 40
Study Start Date: June 2009
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Btx-A and Kinesiotherapy
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
Stroke, Botulinum Toxin
Other Name: Dysport
Placebo Comparator: Saline and Kinesiotherapy
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
Saline and Kinesiotherapy

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 collected by a questionnaire, the range of movement will be measured with a goniometer, and the muscle tone will be determine by the modified Ashworth scale, with the patient in dorsal decubitus. The presence of hypertonia equal or superior to 2 will assign the respective muscle to injection. Then the patients will be conducted to another room, where another therapist will assess the functional performance by the "timed up and go" (TUG) test, a six-minutes duration walking, and the Fugl-Meyer scale for the upper limb, with the patient in the seated position. During the TUG test the patient is asked to stand up from a chair and walk 3 meters, turn around 180 degrees, and walk back to the chair, assuming 10 seconds as the normal. The 6 minutes walking test will measure the distance in meters in a previously demarcated place. A staff will constantly stimulate the patient verbally, to walk as fast as possible.

Posteriorly the patients will be set in another room, where a neurologist will inject one of the two possible substances, with a pre-determined dosage and dilution. The botulinum toxin group will have the syringe filled with botulinum toxin type A (Dysport) and the control group will have the syringe filled with saline. All the patients will be reassessed in three and six months for a new injection, and will undergo the last evaluation in nine months.

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 (appendix D). There will be appointments twice a week, one day apart. The duration of the session will be 30 minutes, being 1 minute the interval between the activities. The first 5 minutes will comprise the flexibility exercises, with sustained stretching (15 seconds) and joint mobilizations, followed by a muscle strength exercise involving concentric and eccentric movements, with a progressive charge depending on the patient performance within the following 10 minutes. The last 15 minutes will have a functional training involving gait and upper limb activity combined with endurance training. These activities will be divided into two days: the first day for the trunk and upper limb, and the second for the pelvic, gait, and lower limb exercises. This protocol will be carried out by two physical therapist blinded regarding to the drug injection.

  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00999180


Locations
Brazil
Federal University of Bahia
Salvador, Bahia, Brazil
Sponsors and Collaborators
Federal University of Bahia
Investigators
Principal Investigator: Ailton Melo, PHD Federal University of Bahia
  More Information

Responsible Party: Ailton de Souza Melo, Botulinum Toxin Type A and Kinesitherapy Use in the Functional Performance of Post-stroke Patients, Federal University of Bahia
ClinicalTrials.gov Identifier: NCT00999180     History of Changes
Other Study ID Numbers: UFBA-064
First Submitted: October 20, 2009
First Posted: October 21, 2009
Last Update Posted: December 15, 2011
Last Verified: October 2009

Keywords provided by Ailton de Souza Melo, Federal University of Bahia:
Botulinum Toxin
Rehabilitation
Stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
onabotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents