Xeomin® and Gait Related Mobility After Stroke

NCT04908423 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: IRB00082738BTX1.0
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Instrumented Timed Up and Go test time

  Subjects arise from a chair, walk at their normal speed, turn around right after passing the tape at the end of the pathway, return to the chair, turn around and sit down. Subjects will be fitted with a , single Attitude and heading reference system (AHRS) sensor fixed on the manubrium inferior to the interclavicular notch in a chest-mounted pack. The AHRS is a wireless-telemetry, 10-parameter unit which includes a tri-axial accelerometer, a tri-axial gyroscope, a tri-axial magnetometer and an onboard temperature sensor.

  Baseline and 4-6 weeks after Xeomin injection

Secondary Outcomes (9)

• Change in Ten-meter walk test time

  Baseline and 4-6 weeks after Xeomin injection

• Change in Mini-Mental State Examination score

  Baseline and 4-6 weeks after Xeomin injection

• Change in Quality of Life in Neurological Disorders (Neuro-QoL) Depression - Short Form score

  Baseline and 4-6 weeks after Xeomin injection

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) General Life Satisfaction - Short Form 5a score

  Baseline and 4-6 weeks after Xeomin injection

• Change in Brief Pain Inventory (BPI) - Short Form score

  Baseline and 4-6 weeks after Xeomin injection

Study Arms (1)

Xeomin®

EXPERIMENTAL

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

Drug: Xeomin®

Interventions

Xeomin® DRUG

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.

Also known as: IncobotulinumtoxinA

Xeomin®

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Merz Pharmaceuticals GmbH: collaborator

Study Sites (1)

Carolinas Rehabilitation

Charlotte, North Carolina, 28203, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

incobotulinumtoxinA

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Mark A Hirsch, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark A Hirsch, PhD

CONTACT

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

Kiandra Austrie, RN, BSN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: To assess if Xeomin® injection into the hemiparetic arm is associated with changes in hemiparetic elbow range of motion, a blinded investigator will visually observe the position of the injected arm during their 10-meter walk test, using video tape sequences of the pre- and post-test gait analysis sessions.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A one-group pretest-post-test experimental design will be used. Participants will be tested on the primary and secondary outcome measures before upper extremity injection with Xeomin® and 4 to 6 weeks thereafter.

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: June 1, 2021
• Study Start: October 19, 2021
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)