Evaluating Xeomin® for improving mobility after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to assess the impact of Xeomin® injections on gait-related mobility in adult patients with hemiparesis following a stroke. Participants will undergo standardized physical function tests, including the 10-meter walk test and the timed 'up and go' test, before and 4-6 weeks after receiving the injection. The study will utilize a one-group pretest-post-test design to measure changes in mobility and will follow up with participants approximately 12 weeks post-injection to monitor any adverse events and therapeutic duration. The overall duration of the study is planned for 2 years to facilitate adequate screening, recruitment, and follow-up.

Why it matters

Who can join: the full rules

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)

Where it's running

• Carolinas Rehabilitation
  Charlotte, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Mark A Hirsch, PhD — Wake Forest University Health Sciences
• Study coordinator: Mark A Hirsch, PhD
• Email: Mark.Hirsch@atriumhealth.org
• Phone: 704-355-7673

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.