Reduce Inefficiencies in Management of Spasticity (ReIMage)

June 4, 2026 updated by: Sean Savitz, The University of Texas Health Science Center, Houston
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of care
Other: Standard 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.
Experimental: Screener
Other: Screener
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to detect spasticity from incidence of stroke
Time Frame: From baseline to 24 months after stroke
From baseline to 24 months after stroke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to referral for spasticity from incidence of stroke
Time Frame: From baseline to 24 months after stroke
Evaluate average time to referral to neurology or Physical Medicine & Rehabilitation (PM&R)
From baseline to 24 months after stroke
The time from incidence of stroke to Botulinum neurotoxin (BoNT) administration
Time Frame: From baseline to 24 months after stroke
From baseline to 24 months after stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

AbbVie

Investigators

  • Principal Investigator: Sean I Savitz, MD, The University of Texas Health Science Center at Houston PO Box 20036

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

November 30, 2029

Study Registration Dates

First Submitted

June 4, 2026

First Submitted That Met QC Criteria

June 4, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-26-0099

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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