Evaluating Xeomin® for improving mobility after stroke
Upper Extremity Injection of Xeomin® and Changes in Gait Related Mobility in Adults After Stroke
This study is testing if Xeomin® injections can help improve walking and movement in adults who have weakness on one side after a stroke.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 79 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Charlotte, North Carolina) |
| Trial ID | NCT04908423 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are ambulatory adults with hemiparesis and spasticity due to stroke who can walk at least 10 meters independently.
Not a fit: Patients with significant joint restrictions, uncorrected hearing impairments, or other neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mobility and quality of life for stroke survivors experiencing hemiparesis.
How similar studies have performed: While similar approaches have been explored, this specific application of Xeomin® for gait improvement post-stroke is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Charlotte, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.