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NCT Number: NCT07639632

Reduce Inefficiencies in Management of Spasticity

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Screener

Other

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

Standard of care

Other

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.

Primary outcomes

  1. Time to detect spasticity from incidence of stroke

    Time frame: From baseline to 24 months after stroke

Secondary outcomes

  1. 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)

  2. The time from incidence of stroke to Botulinum neurotoxin (BoNT) administration

    Time frame: From baseline to 24 months after stroke

Study contacts

Contact information is provided by the study sponsor or research team.

Harriet Sales

CONTACT

[email protected]

(713) 500-7037

Sean I Savitz, MD

CONTACT

[email protected]

(713) 500-7083

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • AbbVie

Registry information

Acronym: ReIMage

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jun 10, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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