NCT04908423 Xeomin® and Gait Related Mobility After Stroke
| NCT ID | NCT04908423 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-10-19 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 20 participants in total. It began in 2021-10-19 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Contact & Investigator
Mark A Hirsch, PhD
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT04908423 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 79 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04908423 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04908423 currently recruiting?
Yes, NCT04908423 is actively recruiting participants. Contact the research team at Mark.Hirsch@atriumhealth.org for enrollment information.
Where is the NCT04908423 trial being conducted?
This trial is being conducted at Charlotte, United States.
Who is sponsoring the NCT04908423 clinical trial?
NCT04908423 is sponsored by Wake Forest University Health Sciences. The principal investigator is Mark A Hirsch, PhD at Wake Forest University Health Sciences. The trial plans to enroll 20 participants.
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