Xeomin® and Gait Related Mobility After Stroke

Upper Extremity Injection of Xeomin® and Changes in Gait Related Mobility in Adults After Stroke

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).

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Drug: Xeomin®

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mark A Hirsch, PhD; Phone Number: 704-355-7673; Email: Mark.Hirsch@atriumhealth.org
• Study Contact Backup: Name: Christine Patino, RN, BSN; Phone Number: 704-355-9368; Email: Christine.Patino@atriumhealth.org

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Recruiting
      • Carolinas Rehabilitation
      • Contact: Mark A Hirsch, PhD; Phone Number: 704-355-7673; Email: Mark.Hirsch@atriumhealth.org
      • Principal Investigator: Mark A Hirsch, PhD
      • Sub-Investigator: Vu QC Nguyen, MD, MBA
      • Sub-Investigator: Nahir Habet, MS
      • Sub-Investigator: Mark A Newman, PhD
      • Contact: Christine Patino, RN, BSN; Phone Number: 704-355-9368; Email: Christine.Patino@atriumhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Drug: 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.; Other Names: IncobotulinumtoxinA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Ten-meter walk test time	Subjects walk 10-meters at self-selected pace	Baseline and 4-6 weeks after Xeomin injection
Change in Mini-Mental State Examination score	Quantitative assessment of cognitive impairment. Scores range from 0-30, higher scores represent less cognitive impairment.	Baseline and 4-6 weeks after Xeomin injection
Change in Quality of Life in Neurological Disorders (Neuro-QoL) Depression - Short Form score	Eight-item assessment of loss and feelings of hopelessness, negative mood, decrease in positive affect, information-processing deficits, negative views of the self, and negative social cognition in patients with neurological disorders. Scores range from 8-40, higher scores represent greater depressive symptoms.	Baseline and 4-6 weeks after Xeomin injection
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) General Life Satisfaction - Short Form 5a score	This form consists of 5-items and assesses the participant's cognitive evaluation of life experiences and whether that participant is content with their life. Scores range from 5-35, higher scores represent increased life satisfaction.	Baseline and 4-6 weeks after Xeomin injection
Change in Brief Pain Inventory (BPI) - Short Form score	The BPI is a self-report measure that assesses severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours. For the pain intensity portion of the assessment, scores range from 0-40, higher scores represent increased pain intensity. For the pain interference portion of the scale, scores range from 0-70, higher scores represent increased pain interference.	Baseline and 4-6 weeks after Xeomin injection
Change in Neuro-QoL Satisfaction with Social Roles and Activities - Short Form score	A reliable and valid 8-item measure of involvement in social roles, activities and responsibilities. Scores for the social roles portion of the assessment range from 4-20, higher scores represent increased satisfaction with social roles. Scores for the activities portion of the assessment range from 4-20, higher scores represent increased activity satisfaction.	Baseline and 4-6 weeks after Xeomin injection
Change in Modified Ashworth Scale (MAS) score	The MAS will be used as a measure of spasticity. Scores range from 0-4 for each muscle tested, higher scores represent increased spasticity.	Baseline and 4-6 weeks after Xeomin injection
Change in Berg Balance Scale (BBS) score	The BBS is a 14-item objective tool that assesses static balance and fall risk in adults' post-stroke. Scores range from 0-56, higher scores indicate increased functional balance.	Baseline and 4-6 weeks after Xeomin injection
Change in Activities-Specific Balance (ABC) Scale score	The ABC scale is a 16-item self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. Scores range from 0-100, higher scores indicate increased self-confidence with balance.	Baseline and 4-6 weeks after Xeomin injection

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Merz Pharmaceuticals GmbH
• Investigators: Principal Investigator: Mark A Hirsch, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2021
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; incobotulinumtoxinA
• Other Study ID Numbers: IRB00082738; BTX1.0 (Other Identifier: Atrium Health)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No