Xeomin® and Gait Related Mobility After Stroke

Wake Forest University (WFU)

Status and phase: Enrolling; Phase 4

Conditions: Stroke

Treatments: Drug: Xeomin®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04908423

BTX1.0

IRB00082738

Details and patient eligibility

About

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).

Full description

For this pilot study, the investigators hypothesize that there will be durational improvements in gait related mobility on the instrumented TUG and 10-meter walk tests 4-6-weeks post upper extremity Xeomin® injection. Physical function will be quantified as time to complete the instrumented TUG.

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. Additionally, participants will be contacted for an end of study visit via telephone approximately 12-weeks post Xeomin® injection to obtain information regarding any adverse events and gain insight into the therapeutic duration of the Xeomin®. The proposed duration of the study is 2 years to allow adequate time for screening, recruitment and follow-up.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Xeomin®

Experimental group

Description:

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

Treatment:

Drug: Xeomin®