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

NCT00565201 | Completed Early Phase 1

• 1 other identifier: IRB00002727
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke, Cerebrovascular accident, Spasticity, Arm, Hand

Outcome Measures

Primary Outcomes (2)

• Wolf Motor Function Test

  Baseline, Pre-therapy, Post-therapy, and 1 month after therapy

• Arm Motor Ability Test

  Baseline, Pre-therapy, Post-therapy, and 1 month after therapy

Secondary Outcomes (4)

• Stroke Impact Scale

  Baseline, Pre-therapy, Post-therapy, and 1 month after therapy

• Modified Ashworth Scale

  Baseline, Pre-therapy, Post-therapy, and 1 month after therapy

• Upper Extremity range of motion measurements

  Baseline, Pre-therapy, Post-therapy, and 1 month after therapy

• Caregiver questionnaire

  Baseline, Pre-therapy, Post-therapy, and 1 month after therapy

Study Arms (2)

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.

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.

Drug: Placebo and rehab

Interventions

Botox and rehab DRUG

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.

Botox and Rehab

Placebo and rehab DRUG

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.

Placebo and Rehab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead
• Allergan: collaborator

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

Botulinum Toxins, Type A; Rehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Steven L Wolf, PhD, PT

  Emory University

  PRINCIPAL INVESTIGATOR

• Byron Milton, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 20, 2007
• First Posted: November 29, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2011
• Last Updated: August 13, 2013

Record last verified: 2013-08

Locations

US (1)