Status:
RECRUITING
Xeomin® and Gait Related Mobility After Stroke
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Merz Pharmaceuticals GmbH
Conditions:
Stroke
Eligibility:
All Genders
18-79 years
Phase:
PHASE4
Brief Summary
The aim of the present pilot study is to evaluate the association between change in gait related mobility in ambulatory male and female adult hemiparetic patients before and 4-6-weeks after Xeomin® in...
Detailed Description
For this pilot study, the investigators hypothesize that there will be durational improvements in gait related mobility on the instrumented TUG and 10-meter walk tests 4-6-weeks post upper extremity X...
Eligibility Criteria
Inclusion
- Diagnosis of hemiparesis and spasticity secondary to stroke with upper and lower limb spasticity and unilateral motor and/or sensory deficit
- 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
- Passive range of motion at either the ankle, knee, or elbow joint less than 30 degrees
- 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)
Key Trial Info
Start Date :
October 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04908423
Start Date
October 19 2021
End Date
April 1 2027
Last Update
November 25 2025
Active Locations (1)
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1
Carolinas Rehabilitation
Charlotte, North Carolina, United States, 28203