Xeomin® and Gait Related Mobility After Stroke

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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® injection into the upper limb, using two standardized tests of physical function in outpatient rehabilitation that are widely used; the 10-meter walk test and the timed 'up and go' test (TUG).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Atrium Health
• Collaborator: Merz Pharmaceuticals GmbH
• Treatments: incobotulinumtoxinA

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)