Botulinum Toxin Type A and Kinesitherapy of Post-stroke Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Federal University of Bahia.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Ailton de Souza Melo, Federal University of Bahia
ClinicalTrials.gov Identifier:
NCT00999180
First received: October 20, 2009
Last updated: December 14, 2011
Last verified: October 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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
Other Name: 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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 20, 2009
Last Updated: December 14, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Bahia:
Botulinum Toxin
Rehabilitation
Stroke

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014