Not yet recruiting NCT07639632
Reduce Inefficiencies in Management of Spasticity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Screener, Standard of care.
- Who it may be relevant to
- Registry conditions: Stroke. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- 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 - 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.
Primary outcome measures
- Time to detect spasticity from incidence of stroke [Time frame: From baseline to 24 months after stroke]
Secondary outcome measures (2)
- Time to referral for spasticity from incidence of stroke [Time frame: 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- The University of Texas Health Science Center at Houston PO Box 20036 — Houston
Identifiers
NCT: NCT07639632 · HSC-MS-26-0099