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Xeomin® and Gait Related Mobility After Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Xeomin®
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Carolinas RehabilitationRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Xeomin®

Arm 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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Ten-meter walk test time
Subjects walk 10-meters at self-selected pace
Change in Mini-Mental State Examination score
Quantitative assessment of cognitive impairment. Scores range from 0-30, higher scores represent less cognitive impairment.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 25, 2021
Last Updated
June 2, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
Merz Pharmaceuticals GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04908423
Brief Title
Xeomin® and Gait Related Mobility After Stroke
Official Title
Upper Extremity Injection of Xeomin® and Changes in Gait Related Mobility in Adults After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Merz Pharmaceuticals GmbH

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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)
Masking Description
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.
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xeomin®
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Xeomin®
Other Intervention Name(s)
IncobotulinumtoxinA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Instrumented Timed Up and Go test time
Description
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.
Time Frame
Baseline and 4-6 weeks after Xeomin injection
Secondary Outcome Measure Information:
Title
Change in Ten-meter walk test time
Description
Subjects walk 10-meters at self-selected pace
Time Frame
Baseline and 4-6 weeks after Xeomin injection
Title
Change in Mini-Mental State Examination score
Description
Quantitative assessment of cognitive impairment. Scores range from 0-30, higher scores represent less cognitive impairment.
Time Frame
Baseline and 4-6 weeks after Xeomin injection
Title
Change in Quality of Life in Neurological Disorders (Neuro-QoL) Depression - Short Form score
Description
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.
Time Frame
Baseline and 4-6 weeks after Xeomin injection
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) General Life Satisfaction - Short Form 5a score
Description
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.
Time Frame
Baseline and 4-6 weeks after Xeomin injection
Title
Change in Brief Pain Inventory (BPI) - Short Form score
Description
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.
Time Frame
Baseline and 4-6 weeks after Xeomin injection
Title
Change in Neuro-QoL Satisfaction with Social Roles and Activities - Short Form score
Description
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.
Time Frame
Baseline and 4-6 weeks after Xeomin injection
Title
Change in Modified Ashworth Scale (MAS) score
Description
The MAS will be used as a measure of spasticity. Scores range from 0-4 for each muscle tested, higher scores represent increased spasticity.
Time Frame
Baseline and 4-6 weeks after Xeomin injection
Title
Change in Berg Balance Scale (BBS) score
Description
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.
Time Frame
Baseline and 4-6 weeks after Xeomin injection
Title
Change in Activities-Specific Balance (ABC) Scale score
Description
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.
Time Frame
Baseline and 4-6 weeks after Xeomin injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark A Hirsch, PhD
Phone
704-355-7673
Email
Mark.Hirsch@atriumhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberley Thompson
Phone
704-355-1409
Email
Kimberley.Thompson@atriumhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark A Hirsch, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolinas Rehabilitation
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark A Hirsch, PhD
Phone
704-355-7673
Email
Mark.Hirsch@atriumhealth.org
First Name & Middle Initial & Last Name & Degree
Kimberley Thompson
Phone
704-355-1409
Email
Kimberley.Thompson@atriumhealth.org
First Name & Middle Initial & Last Name & Degree
Mark A Hirsch, PhD
First Name & Middle Initial & Last Name & Degree
Vu QC Nguyen, MD, MBA
First Name & Middle Initial & Last Name & Degree
Nahir Habet, MS
First Name & Middle Initial & Last Name & Degree
Mark A Newman, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Xeomin® and Gait Related Mobility After Stroke

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