Xeomin® and Gait Related Mobility After Stroke

  • STATUS
    Recruiting
  • End date
    May 11, 2023
  • participants needed
    20
  • sponsor
    Wake Forest University Health Sciences
Updated on 11 May 2022

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).

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 Xeomin® injection. Physical function will be quantified as time to complete the instrumented TUG.

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.

Details
Condition Stroke
Treatment Xeomin®
Clinical Study IdentifierNCT04908423
SponsorWake Forest University Health Sciences
Last Modified on11 May 2022

Eligibility

Yes No Not Sure

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)
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