Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
20 participants
INTERVENTIONAL
2021-10-19
2027-04-30
Brief Summary
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Detailed Description
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A one-group pretest-post-test experimental design will be used. Participants will be tested on the primary and secondary outcome measures before upper extremity injection with Xeomin® and 4 to 6 weeks thereafter. Additionally, participants will be contacted for an end of study visit via telephone approximately 12-weeks post Xeomin® injection to obtain information regarding any adverse events and gain insight into the therapeutic duration of the Xeomin®. The proposed duration of the study is 2 years to allow adequate time for screening, recruitment and follow-up.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Xeomin®
Participants will be injected via electromyographic guidance with a total of 200 units of Xeomin® into the pectoralis major, biceps brachii, brachioradialis, and latissimus dorsi muscles of the hemiparetic side using a standardized injection protocol (16). An additional 100 units of Xeomin® will be available at the discretion of the investigator for injection into additional affected upper extremity muscles
Xeomin®
To discover whether injection into the upper extremity with Xeomin® triggers improvements in gait-related mobility and quality of life in adults with hemiparesis secondary to stroke.
Interventions
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Xeomin®
To discover whether injection into the upper extremity with Xeomin® triggers improvements in gait-related mobility and quality of life in adults with hemiparesis secondary to stroke.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No prior surgery to the lower limb
* Able to walk at least 10 meters without physical assistance from another person and without an assistive device
* Toe- ground clearance during swing phase without assistive device or orthoses
* No treatment with botulinum toxin within the past 4 months
Exclusion Criteria
* Participants with uncorrected hearing impairment
* Weight bearing restrictions due to concurrent orthopedic injuries that would make ambulating with or without an assistive device unsafe
* Speech language expression deficit (e.g., aphasia)
* Absence of proprioception upon neurologic examination
* Presence of fixed contractures in the upper or lower extremities not correctable to neutral
* Other confounding neurological diagnoses or active acute illness (cancer, Parkinson's disease, multiple sclerosis)
18 Years
79 Years
ALL
No
Sponsors
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Merz Pharmaceuticals GmbH
INDUSTRY
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Mark A Hirsch, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Carolinas Rehabilitation
Charlotte, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BTX1.0
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00082738
Identifier Type: -
Identifier Source: org_study_id
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