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Recruiting NCT04908423

Xeomin® and Gait Related Mobility After Stroke

Phase IV Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Xeomin®.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 18 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Change in Instrumented Timed Up and Go test time [Time frame: Baseline and 4-6 weeks after Xeomin injection]
Secondary outcome measures (9)
  • 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]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Carolinas Rehabilitation — Charlotte

Identifiers

NCT: NCT04908423 · IRB00082738 · BTX1.0

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗