Recruiting

Xeomin & Gait

Sponsor:

Wake Forest University Health Sciences

Code:

NCT04908423

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Xeomin®

Study Details

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).

Conditions

Stroke

Study ID

NCT04908423

Start date

Oct 19, 2021

Status verified date

Nov, 2025

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Xeomin®

Participants will be injected via electromyographic guidance with a total of 200 units of Xeomin® into the pectoralis major, biceps brachii, brachioradialis, and latissimus dorsi muscles of the hemiparetic side using a standardized injection protocol (16). An additional 100 units of Xeomin® will be available at the discretion of the investigator for injection into additional affected upper extremity muscles

Interventions

Xeomin®

To discover whether injection into the upper extremity with Xeomin® triggers improvements in gait-related mobility and quality of life in adults with hemiparesis secondary to stroke.

Primary outcome measure

  • Change in Instrumented Timed Up and Go test time [ Time Frame: Baseline and 4-6 weeks after Xeomin injection ]

Central Contacts and Locations

Central contacts

Mark A Hirsch, PhD

704-355-7673Mark.Hirsch@atriumhealth.org

Kiandra Austrie, RN, BSN

704-355-1525Kiandra.austrie@Advocatehealth.org

Locations

Carolinas Rehabilitation

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

Mark A Hirsch, PhD

704-355-7673Mark.Hirsch@atriumhealth.org

Kiandra Austrie, RN, BSN

704-355-1525Kiandra.austrie@Advocatehealth.org

Principal Investigator:

Mark A Hirsch, PhD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Nov 25, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2025-11-25.