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Evaluation of BOTOX® With Rehabilitation Therapy for the Treatment of Wrist and Hand Spasticity in Post-Stroke Patients (Botox/Rehab)

Primary Purpose

Stroke

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Botox and rehab
Placebo and rehab
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Cerebrovascular accident, Spasticity, Arm, Hand

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Emory University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Botox and Rehab

Placebo and Rehab

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Wolf Motor Function Test
Arm Motor Ability Test

Secondary Outcome Measures

Stroke Impact Scale
Modified Ashworth Scale
Upper Extremity range of motion measurements
Caregiver questionnaire

Full Information

First Posted
November 20, 2007
Last Updated
August 9, 2013
Sponsor
Emory University
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00565201
Brief Title
Evaluation of BOTOX® With Rehabilitation Therapy for the Treatment of Wrist and Hand Spasticity in Post-Stroke Patients
Acronym
Botox/Rehab
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Cerebrovascular accident, Spasticity, Arm, Hand

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Botox and Rehab
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo and Rehab
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Botox and rehab
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo and rehab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wolf Motor Function Test
Time Frame
Baseline, Pre-therapy, Post-therapy, and 1 month after therapy
Title
Arm Motor Ability Test
Time Frame
Baseline, Pre-therapy, Post-therapy, and 1 month after therapy
Secondary Outcome Measure Information:
Title
Stroke Impact Scale
Time Frame
Baseline, Pre-therapy, Post-therapy, and 1 month after therapy
Title
Modified Ashworth Scale
Time Frame
Baseline, Pre-therapy, Post-therapy, and 1 month after therapy
Title
Upper Extremity range of motion measurements
Time Frame
Baseline, Pre-therapy, Post-therapy, and 1 month after therapy
Title
Caregiver questionnaire
Time Frame
Baseline, Pre-therapy, Post-therapy, and 1 month after therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven L Wolf, PhD, PT
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Byron Milton, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

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Evaluation of BOTOX® With Rehabilitation Therapy for the Treatment of Wrist and Hand Spasticity in Post-Stroke Patients

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