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Search / Trial NCT04908423

Xeomin® and Gait Related Mobility After Stroke

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · May 27, 2021

Trial Information

Current as of August 21, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how a treatment called Xeomin® can help improve walking and mobility in adults who have had a stroke. Specifically, it looks at how people's ability to walk changes before they receive an injection of Xeomin® in their arm and again 4 to 6 weeks after the injection. Researchers will use two common tests to measure this: the 10-meter walk test, which checks how fast someone can walk, and the timed 'up and go' test, which assesses how quickly a person can stand up from a chair, walk a short distance, and sit back down.

To participate in this trial, individuals need to be between 18 and 85 years old, have difficulty moving one side of their body due to a stroke, and be able to walk at least 10 meters without help or using devices like a walker. Participants will not have had any major surgeries on their legs or recent treatments with similar medications within the last four months. If someone joins the study, they can expect to receive an injection, undergo physical tests before and after the treatment, and contribute to important research that could help others in the future.

Gender

ALL

Eligibility 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)

About Wake Forest University Health Sciences

Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.

Locations

Charlotte, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Mark A Hirsch, PhD

Principal Investigator

Wake Forest University Health Sciences

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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