RecruitingPhase 4NCT04908423

Xeomin® and Gait Related Mobility After Stroke

Upper Extremity Injection of Xeomin® and Changes in Gait Related Mobility in Adults After Stroke


Sponsor

Wake Forest University Health Sciences

Enrollment

20 participants

Start Date

Oct 19, 2021

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 79 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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)

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Interventions

DRUGXeomin®

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.


Locations(1)

Carolinas Rehabilitation

Charlotte, North Carolina, United States

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NCT04908423


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