Clinical trial NCT04908423: 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
Overall status: RECRUITING
Phase: PHASE4
Conditions: Stroke
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Merz Pharmaceuticals GmbH
First posted: 2021-06-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in Instrumented Timed Up and Go test time
timeFrame: Baseline and 4-6 weeks after Xeomin injection
Secondary outcomes:
measure: Change in Ten-meter walk test time
timeFrame: Baseline and 4-6 weeks after Xeomin injection
measure: Change in Mini-Mental State Examination score
timeFrame: Baseline and 4-6 weeks after Xeomin injection
measure: Change in Quality of Life in Neurological Disorders (Neuro-QoL) Depression - Short Form score
timeFrame: Baseline and 4-6 weeks after Xeomin injection
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) General Life Satisfaction - Short Form 5a score
timeFrame: Baseline and 4-6 weeks after Xeomin injection
measure: Change in Brief Pain Inventory (BPI) - Short Form score
timeFrame: Baseline and 4-6 weeks after Xeomin injection
measure: Change in Neuro-QoL Satisfaction with Social Roles and Activities - Short Form score
timeFrame: Baseline and 4-6 weeks after Xeomin injection
measure: Change in Modified Ashworth Scale (MAS) score
timeFrame: Baseline and 4-6 weeks after Xeomin injection
measure: Change in Berg Balance Scale (BBS) score
timeFrame: Baseline and 4-6 weeks after Xeomin injection
measure: Change in Activities-Specific Balance (ABC) Scale score
timeFrame: Baseline and 4-6 weeks after Xeomin injection
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Rehabilitation
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Mark A Hirsch, PhD
role: PRINCIPAL_INVESTIGATOR
References: