Xeomin® and Gait Related Mobility After Stroke

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT04908423
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
Oct 19, 2021
Status verified
Nov 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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

Primary Outcome Measure

Change in Instrumented Timed Up and Go test time [ Time Frame: Baseline and 4-6 weeks after Xeomin injection ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Carolinas RehabilitationCharlotteNorth Carolina28203
Mark A Hirsch, PhD
[email protected]
704-355-7673
Kiandra Austrie, RN, BSN
[email protected]
704-355-1525
Mark A Hirsch, PhD (PRINCIPAL_INVESTIGATOR)
Nathan Darji, BS, DO (SUB_INVESTIGATOR)
Sima Desai, MS, BS, MD (SUB_INVESTIGATOR)
Leon Chandler, MD (SUB_INVESTIGATOR)

Find similar trials in Charlotte, NC

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Carolinas Rehabilitation· Charlotte, NC

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