StrokeNCT00723866
Botulinum Toxin Type A and Modified Constraint-Induced Movement Therapy for Poststroke Upper Extremity Spasticity
A study testing BtxA+mCIMT and BtxA+ conventional rehabilitation in people with Stroke, run by Kaohsiung Veterans General Hospital..
Trial summary
Botulinum toxin type A (BtxA) injection and modified constraint-induced movement therapy (mCIMT) are both promising approaches to enhance recovery after stroke. However, the combined application of the two modalities has rarely been studied. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- BtxA+mCIMT and BtxA+ conventional rehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Jun 2008
- 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
- age 18 to 80 years
- at least 1 year after a unilateral stroke
- modified ashworth scale (MAS) score > 3 in the elbow, wrist or finger flexors
- ability to actively extend > 10 degrees at metacarpophalangeal and interphalangeal joints and 20 degrees at wrist of the affected upper limb (minimal motor criteria).
Who cannot join
- presence of fixed joint contractures
- serious balance problems
- preexisting neurological deficits, neuromuscular diseases or uncontrolled medical conditions
- significant cognitive deficits (Mini-Mental Status Examination score < 24)
- excessive pain in the affected upper limb
- previous treatment with Botulinum toxin A, neurolytic agents or surgery for spasticity
- All patients were not currently participating in any experimental studies and did not receive concomitant oral anti-spastic medication during the study period
About this study
Official title: Combined Botulinum Toxin Type A With Modified Constraint-Induced Movement Therapy for Chronic Stroke Patients With Upper Extremity Spasticity
Botulinum toxin type A (BtxA) injection and modified constraint-induced movement therapy (mCIMT) are both promising approaches to enhance recovery after stroke. However, the combined application of the two modalities has rarely been studied. The aim was to investigate whether combined BtxA and mCIMT would produce greater improvements in spasticity and upper extremity function than BtxA plus conventional rehabilitation in chronic stroke patients with upper extremity spasticity.
Read the detailed description
Botulinum toxin type A (BtxA) injection and modified constraint-induced movement therapy (mCIMT)are both promising approaches to enhance recovery after stroke. However, the combined application of the two modalities has rarely been studied. To date, only a single case report addressed this issue. Theoretically, application of a mCIMT program with intensive functional tasks practice after spasticity reduction by BtxA may improve affected upper extremity function in patients with poststroke spasticity. The aim was to investigate whether combined BtxA and mCIMT would produce greater improvements in spasticity and upper extremity function than BtxA plus conventional rehabilitation in chronic stroke patients with upper extremity spasticity.
- Conditions
- Stroke
- Being tested
- BtxA+mCIMT, BtxA+ conventional rehabilitation
- Keywords
- Botulinum toxin, Spasticity, Stroke, Rehabilitation.
- 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.
BtxA+mCIMTOther
Also called the combination group
The combination group receive BtxA+mCIMT for 2 hours/day, 3 days/week for 3 months.
BtxA+ conventional rehabilitationOther
Also called the control group
The control group received for 2 hours/day, 3 days/week for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | BtxA+mCIMT (combination group) Receives: Other: BtxA+mCIMT |
| 2 | Placebo comparator | BtxA+ conventional rehabilitation (control group) Receives: Other: BtxA+ conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome assessed spasticity on the Modified Ashworth Scale.
Measured: MAS evaluated before BtxA injection, at 4 weeks, 3 months and 6 months postinjection.
Secondary outcomes (1)
Secondary outcomes assessed real-world arm function (Motor Activity Log), laboratory motor activity (Action Research Arm Test) and patients' global satisfaction.
Measured: evaluated before BtxA injection, at 4 weeks, 3 months and 6 months postinjection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startDec 2005
- Primary completionNov 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Investigators
- Shu-Fen Sun, MD, Principal investigator, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723866
- Sponsor's protocol ID
- VGHKS94-087
- Status last verified
- Jul 2008
- First submitted
- 25 Jul 2008
- Last updated
- 1 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sun SF, Hsu CW, Hwang CW, Hsu PT, Wang JL, Yang CL. Application of combined botulinum toxin type A and modified constraint-induced movement therapy for an individual with chronic upper-extremity spasticity after stroke. Phys Ther. 2006 Oct;86(10):1387-97. doi: 10.2522/ptj.20050262.
PubMed 17012643
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Botulinum Toxin Type A With Modified Constraint-Induced Movement Therapy for Chronic Stroke Patients With Upper Extremity Spasticity
- ClinicalTrials.gov ID
- NCT00723866
- Acronym / sponsor ID
- VGHKS94-087
- Conditions
- Stroke
- Keywords
- Botulinum toxin, Spasticity, Stroke, Rehabilitation.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- Dec 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 29 Jul 2008 (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.
Botulinum toxin type A (BtxA) injection and modified constraint-induced movement therapy (mCIMT) are both promising approaches to enhance recovery after stroke. However, the combined application of the two modalities has rarely been studied. The aim was to investigate whether combined BtxA and mCIMT would produce greater improvements in spasticity and upper extremity function than BtxA plus conventional rehabilitation in chronic stroke patients with upper extremity spasticity.
Detailed description
Botulinum toxin type A (BtxA) injection and modified constraint-induced movement therapy (mCIMT)are both promising approaches to enhance recovery after stroke. However, the combined application of the two modalities has rarely been studied. To date, only a single case report addressed this issue. Theoretically, application of a mCIMT program with intensive functional tasks practice after spasticity reduction by BtxA may improve affected upper extremity function in patients with poststroke spasticity. The aim was to investigate whether combined BtxA and mCIMT would produce greater improvements in spasticity and upper extremity function than BtxA plus conventional rehabilitation in chronic stroke patients with upper extremity spasticity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: BtxA+mCIMTBtxA+mCIMT (combination group) |
| 2 | Placebo comparator | Other: BtxA+ conventional rehabilitationBtxA+ conventional rehabilitation (control group) |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 to 80 years
- at least 1 year after a unilateral stroke
- modified ashworth scale (MAS) score > 3 in the elbow, wrist or finger flexors
- ability to actively extend > 10 degrees at metacarpophalangeal and interphalangeal joints and 20 degrees at wrist of the affected upper limb (minimal motor criteria).
Key exclusion criteria (7 listed)
- presence of fixed joint contractures
- serious balance problems
- preexisting neurological deficits, neuromuscular diseases or uncontrolled medical conditions
- significant cognitive deficits (Mini-Mental Status Examination score < 24)
- excessive pain in the affected upper limb
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 |
|---|---|---|
| BtxA+mCIMTAlso: the combination groupThe combination group receive BtxA+mCIMT for 2 hours/day, 3 days/week for 3 months. | Other | 1 |
| BtxA+ conventional rehabilitationAlso: the control groupThe control group received for 2 hours/day, 3 days/week for 3 months. | Other | 2 |
Primary outcome
The primary outcome assessed spasticity on the Modified Ashworth Scale.
Time frame: MAS evaluated before BtxA injection, at 4 weeks, 3 months and 6 months postinjection.
1 secondary outcome
Secondary outcomes assessed real-world arm function (Motor Activity Log), laboratory motor activity (Action Research Arm Test) and patients' global satisfaction.
Time frame: evaluated before BtxA injection, at 4 weeks, 3 months and 6 months postinjection.
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 1 Aug 2008.
- Background: PubMed 17012643Sun SF, Hsu CW, Hwang CW, Hsu PT, Wang JL, Yang CL. Application of combined botulinum toxin type A and modified constraint-induced movement therapy for an individual with chronic upper-extremity spasticity after stroke. Phys Ther. 2006 Oct;86(10):1387-97. doi: 10.2522/ptj.20050262.
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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.
Shu-Fen Sun, MD principal investigator
Department of Physical Medicine and Rehabilitation
Questions about this trial
What is this clinical trial studying?
A study testing BtxA+mCIMT and BtxA+ conventional rehabilitation in people with Stroke, run by Kaohsiung Veterans General Hospital..
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 7 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 1 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
The primary outcome assessed spasticity on the Modified Ashworth Scale. (time frame: MAS evaluated before BtxA injection, at 4 weeks, 3 months and 6 months postinjection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00723866, which also lists 1 linked publication.
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 1 Aug 2008.