Trial Summary

Each year, an estimated 3400+ infants in the U.S. experience PAS and have a high likelihood of lifelong impairment in neuromotor and often cognitive functioning, resulting in a high cost burden for families, the healthcare system, and society.  If I-ACQUIRE proves efficacious, then the field will have the critically needed Phase III confirmatory evidence and the specific clinical protocol needed to transform rehabilitation and improve clinical outcomes and quality of life for infants with PAS. 

This is a multi-site trial comparing 2 dosages of a form of intensive pediatric rehabilitation known as Infant ACQUIRE (I-ACQUIRE) to Usual and Customary treatment (U&CT). I-ACQUIRE will be used to treat 8 – 36-month-old children with PAS in either 3 hours/day (Moderate Dose) or 6 hours/day (High Dose) for 5 days/week for 4 weeks. For each child, treatment goals are set with parents who also participate in daily home practice (about 45 minutes/day) with their child.  I-ACQUIRE includes all of the core features of pediatric Constraint-Induced Movement Therapy (CIMT). 

Who  is eligible for the I-ACQUIRE study?

 Your infant or toddler may be eligible if he or she:

• Had a stroke in the newborn period or was thought to have had a stroke even before birth.
• Shows motor weakness or poor control of movements on one side of the body (often diagnosed as hemiparesis)
• Will be between 8 and 36 months old when treatment is received
• Program staff can speak with you to review all eligibility requirements in detail.

What therapy is being offered?

I-ACQUIRE is a form of infant and toddler rehabilitation. Two dosages are being evaluated compared with the treatments that infants and toddlers with hemiparesis typically receive. Both dosages of I-ACQUIRE therapy involve 5 days a week for 4 weeks in a row, provided by a therapist trained in I-ACQUIRE. The general name for this form of therapy is constraint-induced movement therapy (CIMT).

Therapy Groups

Your child will be assigned by chance to 1 of 3 groups:

Group 1: I-ACQUIRE 6 hours daily, 5 days per week for 4 weeks.

Group 2: I-ACQUIRE 3 hours daily, 5 days per week for 4 weeks.

Group 3: Continue the current therapy your child normally receives. Six months later participants in this group can choose to be assigned by chance to the high or low dose of I-ACQUIRE therapy.

*Families will sign an agreement when they enroll to accept the therapy group assigned and attend all 3 required assessments.

I-ACQUIRE therapy involves:

• A cast for your child’s more frequently used arm and hand.
• Your child wearing the cast for 3 ½ weeks while receiving I-ACQUIRE therapy.
• For the last 3 days of therapy, the cast will be removed and the focus will be on bimanual therapy.
• Parents must participate in 1 therapy session each week, and in addition complete a daily home practice program for about 45 minutes each day.

The cast is judged to be clinically safe; it is removed once a week to check that everything is okay.

Where is therapy provided?

Therapy is provided at 12 different locations across the United States. Therapy is provided in your home, a homelike setting (for families who need to relocate for the month of therapy), or a homelike setting in a child-care center or early intervention program that your child attends.

Is there a cost for therapy?

Therapy is provided at no cost to all participating families. However, if a family has to travel to one of the 12 study sites for therapy, you will need to pay for travel and housing arrangements, and travel to all the 3 assessments. More information regarding housing options and scheduling assessments will be made available upon enrollment.

How can I find out more?

We hope you will consider participating in the study. The findings will be helpful to doctors, therapists, and families. The treatment may benefit your child, but it is possible some children will benefit more than others and some may not show benefits.

To learn more about the I-ACQUIRE study, please contact us. We would love to answer your questions!

National email: I-Acquire@vtc.vt.edu

Clinicaltrails.gov: https://clinicaltrials.gov/ct2/show/NCT03910075?term=I-ACQUIRE&draw=2&rank=1