Botulinum Toxin Type A and Kinesitherapy of Post-stroke Patients

Active, not recruiting

Phase 3 Results N/A

Trial Description

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.

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.

Conditions

Interventions

  • Botulinum toxin type A and kinesiotherapy Procedure
    Other Names: Dysport
    Intervention Desc: Stroke, Botulinum Toxin
    ARM 1: Kind: Experimental
    Label: Btx-A and Kinesiotherapy
    Description: 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.
  • Saline and Kinesiotherapy Procedure
    Other Names: Saline and Kinesiotherapy
    Intervention Desc: Saline and Kinesiotherapy
    ARM 1: Kind: Experimental
    Label: Saline and Kinesiotherapy
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Functional performance assessed by TUG test and six minutes walking: an improvement of more than 50% of the expected for each test. one year No
Secondary 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 No

Sponsors