Reduce Inefficiencies in Management of Spasticity
ReIMage
1 other identifier
interventional
80
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Jun 2026
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2026
CompletedFirst Posted
Study publicly available on registry
June 10, 2026
CompletedStudy Start
First participant enrolled
June 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2029
June 12, 2026
June 1, 2026
3.1 years
June 4, 2026
June 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to detect spasticity from incidence of stroke
From baseline to 24 months after stroke
Secondary Outcomes (2)
Time to referral for spasticity from incidence of stroke
From baseline to 24 months after stroke
The time from incidence of stroke to Botulinum neurotoxin (BoNT) administration
From baseline to 24 months after stroke
Study Arms (2)
Screener
EXPERIMENTALStandard of care
ACTIVE COMPARATORInterventions
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
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbViecollaborator
- The University of Texas Health Science Center, Houstonlead
Study Sites (1)
The University of Texas Health Science Center at Houston PO Box 20036
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sean I Savitz, MD
The University of Texas Health Science Center at Houston PO Box 20036
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 4, 2026
First Posted
June 10, 2026
Study Start
June 15, 2026
Primary Completion (Estimated)
August 1, 2029
Study Completion (Estimated)
November 30, 2029
Last Updated
June 12, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share