Stroke
Conditions
Keywords
acute ischemic stroke, intracerebral hemorrhage
Brief summary
The purpose of this study is to evaluate the effectiveness of a spasticity screener and to determine if the spasticity screener results are useful to healthcare providers and impact clinical decision making
Interventions
OTHERScreener
Participants will be screened for spasticity using the 2 question version of the Post-stroke Spasticity Monitoring Questionnaire (PSMQ) at 2 days after discharge, 2 weeks post stroke, 1 month post stroke, 3 months post stroke and every 3 months after for a total of 12 screenings across 24 months
OTHERStandard of care
Observational data for the standard of care group will be obtained via phone every 3 months post stroke up to 24 months, utilizing the Standard of Care Group Questionnaire.
Sponsors
The University of Texas Health Science Center, Houston
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Currently admitted for an acute hemorrhagic or ischemic stroke; recurrent stroke allowed if no spasticity at baseline * NIHSS score of \> 0 on items 5 or 6 (required of at least 1 limb) * Willingness to participate in the study for 24 months * Able to sign consent form or availability of a legally authorized representative to sign * Able to read/write in English * Identified MD for follow up post hospitalization
Exclusion criteria
* Botulinum toxin use for any indication within the past 12 weeks * Acute life threatening illness * Prior limb injury or neurological diagnosis that limited movement in the now affected limb(s) * Any terminal illness that would limit participation in study follow ups * Known spasticity or other movement disorders that impact tone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to detect spasticity from incidence of stroke | From baseline to 24 months after stroke |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to referral for spasticity from incidence of stroke | From baseline to 24 months after stroke | Evaluate average time to referral to neurology or Physical Medicine \& Rehabilitation (PM\&R) |
| The time from incidence of stroke to Botulinum neurotoxin (BoNT) administration | From baseline to 24 months after stroke | — |
Countries
United States
Contacts
CONTACTSean I Savitz, MD
CONTACTHarriet Sales
PRINCIPAL_INVESTIGATORSean I Savitz, MD
The University of Texas Health Science Center at Houston PO Box 20036
Outcome results
None listed