StrokeNCT01817816
Early Injection of Botulinum Toxin on Motor Function and Gait Pattern in Stroke Patients
A study testing Botox_A and Botox_B in people with Stroke and Spasticity, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
Spasticity, muscle weakness, abnormal gait pattern are co-morbidities commonly seen in stroke patients. They cause disabled condition of patients in activities of daily life and functional performance, and also accidental falls and subsequent fractures. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Stroke, Spasticity
- What is being tested?
- Botox_A and Botox_B
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2009to Jun 2015
- Phase
- Interventional
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- first-ever stroke, with spasticity within 3-months (MAS=2~3)
- independent walking 10 meters (with assistive devices)
Who cannot join
- recurrent stroke, cognition impaired
- lower limb fracture
- received anti-spasticity injection in the past
Trial locations and contacts
1 site in 1 country.
About this study
Spasticity, muscle weakness, abnormal gait pattern are co-morbidities commonly seen in stroke patients. They cause disabled condition of patients in activities of daily life and functional performance, and also accidental falls and subsequent fractures.
This study is to evaluate and compare the effects of different phase injection of Botulinum Toxin Type-A at affected limbs on muscle rheological changes, muscle activity, muscle tone, functional performance, gait pattern and energy consumption in stroke patients.
- Conditions
- Stroke, Spasticity
- Being tested
- Botox_A, Botox_B
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox_AProcedure or surgery
Botox_BProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Botox_A | Experimental | receiving Botulinum Toxin Type-A (Botox-A, Allergan) at both affected lower extremity (aLE) and upper extremity (aUE) Receives: Procedure: Botox_A |
| placebo_A | Placebo comparator | receiving placebo injection at both aLE \& aUE ; receiving Botox-A at both aLE \& aUE at 6-month. Receives: Procedure: Botox_A |
| Botox_B | Experimental | receiving Botox-A injection at aLE and placebo injection (sterile normal saline) at aUE. Receives: Procedure: Botox_B |
| placebo_B | Placebo comparator | receiving placebo injection at both aLE \& aUE ; receiving Botox-A only at aLE at 6-month. Receives: Procedure: Botox_B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the muscle tone in upper and lower extremity
use modified Ashworth Scale to access elbow, wrist, ankle joint muscle tone 0: normal
- slight hypertonus, at the end-range 1+: mild hypertonus, catch when limb is moved (<1/2)
- moderate hypertonus,, limbs moves easily (>1/2)
- passive movement difficult
- rigid
Measured: 4 weeks after injection
Secondary outcomes (1)
Change in the gait pattern as walking
Measured: 4 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study startJan 2009
- Primary completionApr 2015
- Study completionJun 2015
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ta-Sen Wei,MD, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817816
- Sponsor's protocol ID
- CCH-061203
- Status last verified
- Nov 2015
- First submitted
- 21 Mar 2013
- Last updated
- 5 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Injection of Botulinum Toxin on Motor Function and Gait Pattern in Stroke Patients
- ClinicalTrials.gov ID
- NCT01817816
- Acronym / sponsor ID
- CCH-061203
- Conditions
- Stroke, Spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 25 Mar 2013 (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.
Spasticity, muscle weakness, abnormal gait pattern are co-morbidities commonly seen in stroke patients. They cause disabled condition of patients in activities of daily life and functional performance, and also accidental falls and subsequent fractures.
This study is to evaluate and compare the effects of different phase injection of Botulinum Toxin Type-A at affected limbs on muscle rheological changes, muscle activity, muscle tone, functional performance, gait pattern and energy consumption in stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Botox_A | Experimental | Procedure: Botox_Areceiving Botulinum Toxin Type-A (Botox-A, Allergan) at both affected lower extremity (aLE) and upper extremity (aUE) |
| placebo_A | Placebo comparator | Procedure: Botox_Areceiving placebo injection at both aLE \& aUE ; receiving Botox-A at both aLE \& aUE at 6-month. |
| Botox_B | Experimental | Procedure: Botox_Breceiving Botox-A injection at aLE and placebo injection (sterile normal saline) at aUE. |
| placebo_B | Placebo comparator | Procedure: Botox_Breceiving placebo injection at both aLE \& aUE ; receiving Botox-A only at aLE at 6-month. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- first-ever stroke, with spasticity within 3-months (MAS=2~3)
- independent walking 10 meters (with assistive devices)
Key exclusion criteria (3 listed)
- recurrent stroke, cognition impaired
- lower limb fracture
- received anti-spasticity injection in the past
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 |
|---|---|---|
| Botox_A | Procedure or surgery | Botox_A, placebo_A |
| Botox_B | Procedure or surgery | Botox_B, placebo_B |
Primary outcome
Change in the muscle tone in upper and lower extremity
Time frame: 4 weeks after injection
use modified Ashworth Scale to access elbow, wrist, ankle joint muscle tone 0: normal 1. slight hypertonus, at the end-range 1+: mild hypertonus, catch when limb is moved (<1/2) 2. moderate hypertonus,, limbs moves easily (>1/2) 3. passive movement difficult 4. rigid
1 secondary outcome
Change in the gait pattern as walking
Time frame: 4 weeks after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botox_A and Botox_B in people with Stroke and Spasticity, run by Changhua Christian Hospital at 1 site in Taiwan.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 5 Nov 2015. 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 Taiwan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the muscle tone in upper and lower extremity (time frame: 4 weeks after injection). 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 5 Nov 2015.