StrokeEarly Phase 1Botox/RehabNCT00565201
Evaluation of BOTOX® With Rehabilitation Therapy for the Treatment of Wrist and Hand Spasticity in Post-Stroke Patients
A Early Phase 1 study testing Botox and rehab in people with Stroke, run by Emory University at 1 site in United States.
Trial summary
The present study is designed to determine the safety and effectiveness of injections of BOTOX® in spastic muscles of the arm and hand compared with injections of saline (which would do nothing) when combined with rehabilitation therapy for the improvement of active function tasks in post-stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Botox and rehab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Dec 2011
- Phase
- Early Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, 18 to 70 years of age
- Written informed consent
- Written Authorization for Use and Release of Health and Research Study Information has been obtained
- Medically stable condition in the investigator's opinion
- History of stroke (hemorrhagic or ischemic) that resulted in a unilateral, upper-limb focal spasticity pattern of the wrist and fingers
- EMG evidence of volitionary activiation of wrist and finger extensor and flexor muscles
Show all 10Show fewer
- Active range of motion (to be repeated 3 times by the patient): The ability to initiate wrist extension of at least 10 degrees from a fully flexed position with the forearm supported and stabilized in a pronated position. Active shoulder flexion and abduction to 45 degrees and no less than -30 degrees of elbow extension.
- Mini-Mental State Exam (MMSE) >24
- If on an anti-spasticity medication regiment at the time of qualification, the dose regimen must have been stable 1 month prior to study enrollment
- Ability to follow study instructions and likely to complete all required visits
Who cannot join
- Time since neurological event resulting in upper limb spasticity less than 3 months or greater than 24 months
- Previous therapy with BOTOX® or any other botulinum toxin serotype for any condition within the last 12 months
- Phenol or alcohol block in the study limb within 6 months of study enrollment visit
- History (within 3 months of qualification) of or planned (during study period) casting of the study limb
- Current treatment with an intrathecal baclofen pump
- In the opinion of the investigator, profound atrophy of the muscles in the study limb that are targeted for injection
Show all 19Show fewer
- Previous surgical intervention in the study limb, except for routine orthopedic repair for bone fractures, in the last 6 months
- Presence of fixed contracture of the study limb impairing functional activity
- Clinically significant inflammation or condition in the study limb that, in the investigator's opinion, could limit joint movement (other than stroke or spasticity)
- Clinically significant spasticity or contracture of the elbow (defined as an Ashworth score >3) or shoulder in the study limb, in the investigator's opinion would limit sue of the wrist and fingers
- Changes in oral spasticity medications within 30 days of enrollment (dose of anti-spasticity medications should remain the same during the study)
- Anticipated use of oral coagulants during the study
- Known allergy or sensitivity to the study medication or its components
- Infection or dermatological condition at anticipated injection sites
- Current participation in another clinical study or within 1 month of the enrollment visit
- Females who are pregnant, nursing, or planning a pregnancy during the study, or females of childbearing potential, not using a reliable means of contraception
- Anticipated use during the study of concurrent therapies for treatment of upper motor neuron syndrome (eg, acupuncture)
- Any medical condition that may put the patient at increased risk with exposure to BOTOX including diagnosed myasthenia gravis, Eaton-Lambert Syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function
- Patient has a condition or is in a situation which in investigator's opinion may put the patient significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of BOTOX® (Botulinum Toxin Type A) in Combination With Rehabilitation Therapy for the Treatment of Wrist and Hand Muscle Overactivity in Post-Stroke Patients
The present study is designed to determine the safety and effectiveness of injections of BOTOX® in spastic muscles of the arm and hand compared with injections of saline (which would do nothing) when combined with rehabilitation therapy for the improvement of active function tasks in post-stroke patients. Injections will be targeted to reduce common spasticity patterns of the arm and hand which include: bent elbow, palm down forearm, bent wrist, thumb-in-palm, clenched fist, and other hand deformities. This will be done only at Emory University. Neither the doctor injecting the drug nor the subject receiving the drug will know if they are getting BOTOX® or saline. Which type of injection the subject receives will be completely randomized (like flipping a coin). All subjects will have rehabilitation therapy after their injections. Subjects will be assessed at a total of 5 scheduled visits (qualification (Week 1), Injection (Week 2), Evaluations on Weeks 8, 10, and 14. All subjects will receive rehabilitation therapy immediately after their injections for 1 hour a day, 3-5 times a week, for 4 weeks. The results from this project will provide valuable data on the ability of BOTOX® and physical rehabilitation to provide effective treatment to spastic muscles of the arm and hand after stroke. This project has the potential to increase the availability of effective rehabilitation techniques to patients with stroke.
Read the detailed description
After a stroke, patients commonly experience tightness in their affected arm from wrist and hand muscle overactivity called spasticity. Spasticity is difficult to manage with only one type of treatment. Usual treatments of spasticity are not very effective and may produce unwanted side effects. Untreated spasticity may result in muscular problems and decrease a patient's general ability to function and thus affect his/her quality of life.
BOTOX®, a botulinum toxin type A produced from Clostridium botulinum, blocks certain chemicals that cause spasticity. With appropriate injections of BOTOX® in the correct muscle, it can change the tightness in the muscle temporarily. Published reports indicate that several hundred adult patients with arm and/or leg spasticity of various causes (e.g., poststroke, multiple sclerosis and traumatic brain injury) have benefited from injections of BOTOX® in the spastic muscle. The efficacy of BOTOX® in patients with post-stroke spasticity in their arms and hands has been demonstrated in seven phase 2 placebo-controlled studies and two phase 3 studies.
The present study is designed to determine the safety and effectiveness of injections of BOTOX® in spastic muscles of the arm and hand compared with injections of saline (which would do nothing) when combined with rehabilitation therapy for the improvement of active function tasks in post-stroke patients. Injections will be targeted to reduce common spasticity patterns of the arm and hand which include: bent elbow, palm down forearm, bent wrist, thumb-in-palm, clenched fist, and other hand deformities. This will be done only at Emory University. Neither the doctor injecting the drug nor the subject receiving the drug will know if they are getting BOTOX® or saline. Which type of injection the subject receives will be completely randomized (like flipping a coin). All subjects will have rehabilitation therapy after their injections. Subjects will be assessed at a total of 5 scheduled visits (qualification (Week 1), Injection (Week 2), Evaluations on Weeks 8, 10, and 14. All subjects will receive rehabilitation therapy immediately after their injections for 1 hour a day, 3-5 times a week, for 4 weeks. The results from this project will provide valuable data on the ability of BOTOX® and physical rehabilitation to provide effective treatment to spastic muscles of the arm and hand after stroke. This project has the potential to increase the availability of effective rehabilitation techniques to patients with stroke.
- Conditions
- Stroke
- Being tested
- Botox and rehab, Placebo and rehab
- Keywords
- Stroke, Cerebrovascular accident, Spasticity, Arm, Hand
- 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 and rehabDrug
Patients will BOTOX® (100 to 360 U) injected into any of the following muscles: 30-100U in the Flex. Dig. Sublimes (3 sites), 30-100U in the flex. Carpi Rad. (3 sites), 30- 100 U flex Carpi Ulnaris (3 sites), 30-100 U in the flex Dig Superficiali ( 3 sites), 25U Prontator Teres (1 site), 25 U Brachioradialis (1 site) followed by Physical Rehabilitation: One hour session divided into 3 categories of treatment - 1.) Pre-functional/modalities for a general guideline of treatment; 2.)Repetitive task practice and strengthening; 3.)Functional activities - ADL and IADLs.
Placebo and rehabDrug
Patients will receive placebo saline (100 to 360 U) injected into any of the following muscles: 30-100U in the Flex. Dig. Sublimes (3 sites), 30-100U in the flex. Carpi Rad. (3 sites), 30- 100 U flex Carpi Ulnaris (3 sites), 30-100 U in the flex Dig Superficiali ( 3 sites), 25U Prontator Teres (1 site), 25 U Brachioradialis (1 site) followed by Physical Rehabilitation: One hour session divided into 3 categories of treatment - 1.) Pre-functional/modalities for a general guideline of treatment; 2.)Repetitive task practice and strengthening; 3.)Functional activities - ADL and IADLs.
| Study group | Role | What they receive |
|---|---|---|
| Botox and Rehab | Experimental | Patients will receive BOTOX® (100 to 360 U) injected into the any of the following muscles: 30-100U in the Flex. Dig. Sublimes (3 sites), 30-100U in the flex. Carpi Rad. (3 sites), 30- 100 U flex Carpi Ulnaris (3 sites), 30-100 U in the flex Dig Superficiali ( 3 sites), 25U Prontator Teres (1 site), 25 U Brachioradialis (1 site).
Physical Rehabilitation: One hour session divided into 3 categories of treatment - 1.) Pre-functional/modalities for a general guideline of treatment; 2.)Repetitive task practice and strengthening; 3.)Functional activities - ADL and IADLs. Receives: Drug: Botox and rehab |
| Placebo and Rehab | Placebo comparator | Patients will placebo saline (100 to 360 U) injected into any of the following muscles: 30-100U in the Flex. Dig. Sublimes (3 sites), 30-100U in the flex. Carpi Rad. (3 sites), 30- 100 U flex Carpi Ulnaris (3 sites), 30-100 U in the flex Dig Superficiali ( 3 sites), 25U Prontator Teres (1 site), 25 U Brachioradialis (1 site) followed by Physical Rehabilitation: One hour session divided into 3 categories of treatment - 1.) Pre-functional/modalities for a general guideline of treatment; 2.)Repetitive task practice and strengthening; 3.)Functional activities - ADL and IADLs. Receives: Drug: Placebo and rehab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Function Test
Measured: Baseline, Pre-therapy, Post-therapy, and 1 month after therapy
Arm Motor Ability Test
Measured: Baseline, Pre-therapy, Post-therapy, and 1 month after therapy
Secondary outcomes (4)
Stroke Impact Scale
Measured: Baseline, Pre-therapy, Post-therapy, and 1 month after therapy
Modified Ashworth Scale
Measured: Baseline, Pre-therapy, Post-therapy, and 1 month after therapy
Upper Extremity range of motion measurements
Measured: Baseline, Pre-therapy, Post-therapy, and 1 month after therapy
Caregiver questionnaire
Measured: Baseline, Pre-therapy, Post-therapy, and 1 month after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionDec 2009
- Study completionDec 2011
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.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Steven L. Wolf, Emory University
- Investigators
- Steven L Wolf, PhD, PT, Principal investigator, Emory UniversityByron Milton, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00565201
- Sponsor's protocol ID
- IRB00002727
- Acronym
- Botox/Rehab
- Status last verified
- Aug 2013
- First submitted
- 20 Nov 2007
- Last updated
- 13 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of BOTOX® (Botulinum Toxin Type A) in Combination With Rehabilitation Therapy for the Treatment of Wrist and Hand Muscle Overactivity in Post-Stroke Patients
- ClinicalTrials.gov ID
- NCT00565201
- Acronym / sponsor ID
- Botox/Rehab / IRB00002727
- Conditions
- Stroke
- Keywords
- Stroke, Cerebrovascular accident, Spasticity, Arm, Hand
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Oct 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 29 Nov 2007 (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 present study is designed to determine the safety and effectiveness of injections of BOTOX® in spastic muscles of the arm and hand compared with injections of saline (which would do nothing) when combined with rehabilitation therapy for the improvement of active function tasks in post-stroke patients. Injections will be targeted to reduce common spasticity patterns of the arm and hand which include: bent elbow, palm down forearm, bent wrist, thumb-in-palm, clenched fist, and other hand deformities. This will be done only at Emory University. Neither the doctor injecting the drug nor the subject receiving the drug will know if they are getting BOTOX® or saline. Which type of injection the subject receives will be completely randomized (like flipping a coin). All subjects will have rehabilitation therapy after their injections. Subjects will be assessed at a total of 5 scheduled visits (qualification (Week 1), Injection (Week 2), Evaluations on Weeks 8, 10, and 14. All subjects will receive rehabilitation therapy immediately after their injections for 1 hour a day, 3-5 times a week, for 4 weeks. The results from this project will provide valuable data on the ability of BOTOX® and physical rehabilitation to provide effective treatment to spastic muscles of the arm and hand after stroke. This project has the potential to increase the availability of effective rehabilitation techniques to patients with stroke.
Detailed description
After a stroke, patients commonly experience tightness in their affected arm from wrist and hand muscle overactivity called spasticity. Spasticity is difficult to manage with only one type of treatment. Usual treatments of spasticity are not very effective and may produce unwanted side effects. Untreated spasticity may result in muscular problems and decrease a patient's general ability to function and thus affect his/her quality of life.
BOTOX®, a botulinum toxin type A produced from Clostridium botulinum, blocks certain chemicals that cause spasticity. With appropriate injections of BOTOX® in the correct muscle, it can change the tightness in the muscle temporarily. Published reports indicate that several hundred adult patients with arm and/or leg spasticity of various causes (e.g., poststroke, multiple sclerosis and traumatic brain injury) have benefited from injections of BOTOX® in the spastic muscle. The efficacy of BOTOX® in patients with post-stroke spasticity in their arms and hands has been demonstrated in seven phase 2 placebo-controlled studies and two phase 3 studies.
The present study is designed to determine the safety and effectiveness of injections of BOTOX® in spastic muscles of the arm and hand compared with injections of saline (which would do nothing) when combined with rehabilitation therapy for the improvement of active function tasks in post-stroke patients. Injections will be targeted to reduce common spasticity patterns of the arm and hand which include: bent elbow, palm down forearm, bent wrist, thumb-in-palm, clenched fist, and other hand deformities. This will be done only at Emory University. Neither the doctor injecting the drug nor the subject receiving the drug will know if they are getting BOTOX® or saline. Which type of injection the subject receives will be completely randomized (like flipping a coin). All subjects will have rehabilitation therapy after their injections. Subjects will be assessed at a total of 5 scheduled visits (qualification (Week 1), Injection (Week 2), Evaluations on Weeks 8, 10, and 14. All subjects will receive rehabilitation therapy immediately after their injections for 1 hour a day, 3-5 times a week, for 4 weeks. The results from this project will provide valuable data on the ability of BOTOX® and physical rehabilitation to provide effective treatment to spastic muscles of the arm and hand after stroke. This project has the potential to increase the availability of effective rehabilitation techniques to patients with stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox and Rehab | Experimental | Drug: Botox and rehabPatients will receive BOTOX® (100 to 360 U) injected into the any of the following muscles: 30-100U in the Flex. Dig. Sublimes (3 sites), 30-100U in the flex. Carpi Rad. (3 sites), 30- 100 U flex Carpi Ulnaris (3 sites), 30-100 U in the flex Dig Superficiali ( 3 sites), 25U Prontator Teres (1 site), 25 U Brachioradialis (1 site). Physical Rehabilitation: One hour session divided into 3 categories of treatment - 1.) Pre-functional/modalities for a general guideline of treatment; 2.)Repetitive task practice and strengthening; 3.)Functional activities - ADL and IADLs. |
| Placebo and Rehab | Placebo comparator | Drug: Placebo and rehabPatients will placebo saline (100 to 360 U) injected into any of the following muscles: 30-100U in the Flex. Dig. Sublimes (3 sites), 30-100U in the flex. Carpi Rad. (3 sites), 30- 100 U flex Carpi Ulnaris (3 sites), 30-100 U in the flex Dig Superficiali ( 3 sites), 25U Prontator Teres (1 site), 25 U Brachioradialis (1 site) followed by Physical Rehabilitation: One hour session divided into 3 categories of treatment - 1.) Pre-functional/modalities for a general guideline of treatment; 2.)Repetitive task practice and strengthening; 3.)Functional activities - ADL and IADLs. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, 18 to 70 years of age
- Written informed consent
- Written Authorization for Use and Release of Health and Research Study Information has been obtained
- Medically stable condition in the investigator's opinion
- History of stroke (hemorrhagic or ischemic) that resulted in a unilateral, upper-limb focal spasticity pattern of the wrist and fingers
Key exclusion criteria (19 listed)
- Time since neurological event resulting in upper limb spasticity less than 3 months or greater than 24 months
- Previous therapy with BOTOX® or any other botulinum toxin serotype for any condition within the last 12 months
- Phenol or alcohol block in the study limb within 6 months of study enrollment visit
- History (within 3 months of qualification) of or planned (during study period) casting of the study limb
- Current treatment with an intrathecal baclofen pump
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 and rehabPatients will BOTOX® (100 to 360 U) injected into any of the following muscles: 30-100U in the Flex. Dig. Sublimes (3 sites), 30-100U in the flex. Carpi Rad. (3 sites), 30- 100 U flex Carpi Ulnaris (3 sites), 30-100 U in the flex Dig Superficiali ( 3 sites), 25U Prontator Teres (1 site), 25 U Brachioradialis (1 site) followed by Physical Rehabilitation: One hour session divided into 3 categories of treatment - 1.) Pre-functional/modalities for a general guideline of treatment; 2.)Repetitive task practice and strengthening; 3.)Functional activities - ADL and IADLs. | Drug | Botox and Rehab |
| Placebo and rehabPatients will receive placebo saline (100 to 360 U) injected into any of the following muscles: 30-100U in the Flex. Dig. Sublimes (3 sites), 30-100U in the flex. Carpi Rad. (3 sites), 30- 100 U flex Carpi Ulnaris (3 sites), 30-100 U in the flex Dig Superficiali ( 3 sites), 25U Prontator Teres (1 site), 25 U Brachioradialis (1 site) followed by Physical Rehabilitation: One hour session divided into 3 categories of treatment - 1.) Pre-functional/modalities for a general guideline of treatment; 2.)Repetitive task practice and strengthening; 3.)Functional activities - ADL and IADLs. | Drug | Placebo and Rehab |
Primary outcome
Wolf Motor Function Test
Time frame: Baseline, Pre-therapy, Post-therapy, and 1 month after therapy
Arm Motor Ability Test
Time frame: Baseline, Pre-therapy, Post-therapy, and 1 month after therapy
4 secondary outcomes
Stroke Impact Scale
Time frame: Baseline, Pre-therapy, Post-therapy, and 1 month after therapy
Modified Ashworth Scale
Time frame: Baseline, Pre-therapy, Post-therapy, and 1 month after therapy
Upper Extremity range of motion measurements
Time frame: Baseline, Pre-therapy, Post-therapy, and 1 month after therapy
Caregiver questionnaire
Time frame: Baseline, Pre-therapy, Post-therapy, and 1 month after therapy
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 13 Aug 2013.
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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.
Steven L Wolf, PhD, PT principal investigator
Emory University
Byron Milton, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Botox and rehab in people with Stroke, run by Emory University at 1 site in United States.
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 10 inclusion and 19 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 13 Aug 2013. 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 United States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Wolf Motor Function Test (time frame: Baseline, Pre-therapy, Post-therapy, and 1 month after therapy). The study lists 2 primary outcomes in all. 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 13 Aug 2013.