Health TrialsbyHealthPanel

Reduce Inefficiencies in Management of Spasticity

ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe University of Texas Health Science Center, Houston

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Screener

    Other intervention

    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 intervention

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: ScreenerExperimental treatment 1 intervention
Group B: Standard of careActive comparator 1 intervention

Trial outcomes

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

Evaluate average time to referral to neurology or Physical Medicine \& Rehabilitation (PM\&R)

Time frame
From baseline to 24 months after stroke
2

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

Time frame
From baseline to 24 months after stroke

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

AbbVie

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: