StrokePhase 4NCT04908423
Xeomin® and Gait Related Mobility After Stroke
A Phase 4 study testing Xeomin® in people with Stroke, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Stroke
- What is being tested?
- Xeomin®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2021to Apr 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Carolinas Rehabilitation
Charlotte, North Carolina, 28203
Mark A Hirsch, PhD, 704-355-7673, Mark.Hirsch@atriumhealth.org
Tamala Bess, 704-355-9493, tamala.bess@advocatehealth.org
About this study
Official title: 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).
Read the 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.
- Conditions
- Stroke
- Being tested
- Xeomin®
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xeomin®Drug
Also called IncobotulinumtoxinA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Xeomin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4-6 weeks after Xeomin injection
Secondary outcomes (9)
Change in Ten-meter walk test time
Subjects walk 10-meters at self-selected pace
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 4-6 weeks after Xeomin injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start19 Oct 2021
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Merz Pharmaceuticals GmbH
- Responsible party
- Sponsor
- Investigators
- Mark A Hirsch, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908423
- Sponsor's protocol ID
- IRB00082738
- Other IDs
- BTX1.0
- Status last verified
- Oct 2026
- First submitted
- 25 May 2021
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Extremity Injection of Xeomin® and Changes in Gait Related Mobility in Adults After Stroke
- ClinicalTrials.gov ID
- NCT04908423
- Acronym / sponsor ID
- IRB00082738
- Conditions
- Stroke
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Merz Pharmaceuticals GmbH
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Xeomin® | Experimental | Drug: 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 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xeomin®Also: IncobotulinumtoxinATo 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. | Drug | Xeomin® |
Primary outcome
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.
9 secondary outcomes
Change in Ten-meter walk test time
Time frame: Baseline and 4-6 weeks after Xeomin injection
Change in Mini-Mental State Examination score
Time frame: Baseline and 4-6 weeks after Xeomin injection
Change in Quality of Life in Neurological Disorders (Neuro-QoL) Depression - Short Form score
Time frame: Baseline and 4-6 weeks after Xeomin injection
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
Change in Brief Pain Inventory (BPI) - Short Form score
Time frame: Baseline and 4-6 weeks after Xeomin injection
Change in Neuro-QoL Satisfaction with Social Roles and Activities - Short Form score
Time frame: Baseline and 4-6 weeks after Xeomin injection
Change in Modified Ashworth Scale (MAS) score
Time frame: Baseline and 4-6 weeks after Xeomin injection
Change in Berg Balance Scale (BBS) score
Time frame: Baseline and 4-6 weeks after Xeomin injection
Change in Activities-Specific Balance (ABC) Scale score
Time frame: Baseline and 4-6 weeks after Xeomin injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark A Hirsch, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xeomin® in people with Stroke, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark A Hirsch, PhD (704-355-7673, Mark.Hirsch@atriumhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Instrumented Timed Up and Go test time (time frame: Baseline and 4-6 weeks after Xeomin injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.