StrokePhase 3NCT00999180
Botulinum Toxin Type A and Kinesitherapy of Post-stroke Patients
A Phase 3 study testing Botulinum toxin type A and kinesiotherapy and Saline and Kinesiotherapy in people with Stroke, run by Federal University of Bahia at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Botulinum toxin type A and kinesiotherapy and Saline and Kinesiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2009to Apr 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Botulinum Toxin Type A and Kinesitherapy Use in the Functional Performance of Post-stroke Patients
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.
Read the 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
- Stroke
- Being tested
- Botulinum toxin type A and kinesiotherapy, Saline and Kinesiotherapy
- Keywords
- Botulinum Toxin, Rehabilitation, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type A and kinesiotherapyProcedure or surgery
Also called Dysport
Stroke, Botulinum Toxin
Saline and KinesiotherapyProcedure or surgery
Saline and Kinesiotherapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Saline and Kinesiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional performance assessed by TUG test and six minutes walking: an improvement of more than 50% of the expected for each test.
Measured: 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2012 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ailton de Souza Melo, Federal University of Bahia
- Investigators
- Ailton Melo, PHD, Principal investigator, Federal University of Bahia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999180
- Sponsor's protocol ID
- UFBA-064
- Status last verified
- Oct 2009
- First submitted
- 20 Oct 2009
- Last updated
- 15 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin Type A and Kinesitherapy Use in the Functional Performance of Post-stroke Patients
- ClinicalTrials.gov ID
- NCT00999180
- Acronym / sponsor ID
- UFBA-064
- Conditions
- Stroke
- Keywords
- Botulinum Toxin, Rehabilitation, Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 21 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Btx-A and Kinesiotherapy | Active comparator | Procedure: Botulinum toxin type A and kinesiotherapyThe 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 | Placebo comparator | Procedure: Saline and KinesiotherapyThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- Patients with age superior to 70 years
- Cognitive impairment
- Poorly controlled arterial hypertension
- Presence of joint blockade
- Unable to walk independently
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type A and kinesiotherapyAlso: DysportStroke, Botulinum Toxin | Procedure or surgery | Btx-A and Kinesiotherapy |
| Saline and KinesiotherapySaline and Kinesiotherapy | Procedure or surgery | Saline and Kinesiotherapy |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ailton Melo, PHD principal investigator
Federal University of Bahia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum toxin type A and kinesiotherapy and Saline and Kinesiotherapy in people with Stroke, run by Federal University of Bahia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2011.