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NCT Number: NCT04908423

Xeomin® and Gait Related Mobility 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).

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Carolinas Rehabilitation

Charlotte, North Carolina, 28203, United States

Location status: Recruiting

Location contact

Kiandra Austrie, RN, BSN

CONTACT

[email protected]

704-355-1525

Leon Chandler, MD

SUB_INVESTIGATOR

Mark A Hirsch, PhD

CONTACT

[email protected]

704-355-7673

Mark A Hirsch, PhD

PRINCIPAL_INVESTIGATOR

Nathan Darji, BS, DO

SUB_INVESTIGATOR

Sima Desai, MS, BS, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: IncobotulinumtoxinA

Primary outcomes

  1. Change in Instrumented Timed Up and Go test time

    Time frame: Baseline and 4-6 weeks after Xeomin injection

    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.

Secondary outcomes

  1. Change in Ten-meter walk test time

    Time frame: Baseline and 4-6 weeks after Xeomin injection

    Subjects walk 10-meters at self-selected pace

  2. Change in Mini-Mental State Examination score

    Time frame: Baseline and 4-6 weeks after Xeomin injection

    Quantitative assessment of cognitive impairment. Scores range from 0-30, higher scores represent less cognitive impairment.

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

    Time frame: Baseline and 4-6 weeks after Xeomin injection

    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.

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

    Time frame: Baseline and 4-6 weeks after Xeomin injection

    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.

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

    Time frame: Baseline and 4-6 weeks after Xeomin injection

    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.

  6. Change in Neuro-QoL Satisfaction with Social Roles and Activities - Short Form score

    Time frame: Baseline and 4-6 weeks after Xeomin injection

    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.

  7. Change in Modified Ashworth Scale (MAS) score

    Time frame: Baseline and 4-6 weeks after Xeomin injection

    The MAS will be used as a measure of spasticity. Scores range from 0-4 for each muscle tested, higher scores represent increased spasticity.

  8. Change in Berg Balance Scale (BBS) score

    Time frame: Baseline and 4-6 weeks after Xeomin injection

    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.

  9. Change in Activities-Specific Balance (ABC) Scale score

    Time frame: Baseline and 4-6 weeks after Xeomin injection

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kiandra Austrie, RN, BSN

CONTACT

[email protected]

704-355-1525

Mark A Hirsch, PhD

CONTACT

[email protected]

704-355-7673

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Merz Pharmaceuticals GmbH

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2021
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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