Reduce Inefficiencies in Management of Spasticity | NCT07639632

Studies
Reduce Inefficiencies in Management of Spasticity

NCT07639632

Sponsor

The University of Texas Health Science Center, Houston

Status

Not yet recruiting

Last Update Posted

Jun 12, 2026Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Stroke

Interventions

Screener
Standard of care

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 15, 2026Estimated

Primary Completion Date

Aug 1, 2029Estimated

Completion Date

Nov 30, 2029Estimated

First Submitted Date

Jun 4, 2026

First Submission Date that Met QC Criteria

Jun 4, 2026

First Posted Date

Jun 10, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 10, 2026

Last Update Posted Date

Jun 12, 2026Actual

Name	Class
AbbVie	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Screener	Experimental		Other: Screener
Standard of care	Active Comparator		Other: Standard of care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Time to referral for spasticity from incidence of 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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sean I Savitz, MD	Contact	(713) 500-7083		Sean.I.Savitz@uth.tmc.edu
Harriet Sales	Contact	(713) 500-7037		harriet.mari.sales@uth.tmc.edu

Overall Officials

Name	Affiliation	Role
Sean I Savitz, MD	The University of Texas Health Science Center at Houston PO Box 20036	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of Texas Health Science Center at Houston PO Box 20036		Houston	Texas	77030	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke
D000083242	Ischemic Stroke
D002543	Cerebral Hemorrhage

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059039	Standard of Care

Ancestor Terms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation

Browse Leaves

Not provided

Browse Branches

Not provided