Trial Search Results

Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)

This is a Phase III clinical trial to compare the efficacy of two dosages of a new infant rehabilitation protocol - I-ACQUIRE - to usual and customary forms of infant rehabilitation in infants who experienced Perinatal Arterial Stroke (PAS).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Virginia Polytechnic Institute and State University

Collaborator: Ohio State University

Stanford Investigator(s):

Intervention(s):

  • Behavioral: I-ACQUIRE - High Dosage
  • Behavioral: I-ACQUIRE - Moderate Dosage
  • Behavioral: Usual & Customary Treatment (U&CT)

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   - child will be 8 - 36 months old when study treatment will be delivered

   - child has a diagnosis of Perinatal Arterial Stroke (PAS)

   - parent permission to provide the child's clinical MRI to the study

   - child has hemiparesis

   - parent(s) willing to participate in the home therapy component

   - one parent English language proficient and will take the lead in interacting with
   study staff and completing self-administered forms and interviews in English

Exclusion Criteria:

   - child has medical or sensory condition(s) that prevent(s) full therapy participation
   (e.g., frequent uncontrolled seizures, fragile health)

   - child previously received Constraint-Induced Movement Therapy (CIMT) or modified CIMT
   with a dose of at least 2 hrs/day for ≥10 days

   - child received botulinum toxin in past 3 months

   - child is a ward of the state or other agency

Ages Eligible for Study

8 Months - 36 Months

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting