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

Primary Purpose

Perinatal Stroke, Hemiparesis

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
I-ACQUIRE - High Dosage
I-ACQUIRE - Moderate Dosage
Usual & Customary Treatment (U&CT)
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perinatal Stroke focused on measuring P-CIMT, Pediatric Constraint-Induced Movement Therapy, Hemiparesis, Perinatal Stroke, Neonatal Stroke, Pediatric rehabilitation, Infant therapy, Cerebral Palsy, ACQUIRE, I-ACQUIRE

Eligibility Criteria

8 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USCD Health La JollaRecruiting
  • Yale New Haven Children's HospitalRecruiting
  • Ann & Robert H. Lurie Children's Hospital of ChicagoRecruiting
  • Kennedy Krieger Institute - Fairmount RehabilitationRecruiting
  • Boston Children's HospitalRecruiting
  • C.S. Mott Children's HospitalRecruiting
  • Washington University School of Medicine, St. Louis Children's HospitalRecruiting
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • Martha Morehouse Medical PlazaRecruiting
  • Children's Hospital of PhiladelphiaRecruiting
  • The Medical University of South Carolina (MUSC)Recruiting
  • Memorial Hermann Texas Medical CenterRecruiting
  • Fralin Biomedical Research Institute at Virginia TechRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

I-ACQUIRE High Dose

I-ACQUIRE Moderate Dose

Usual & Customary Treatment

Arm Description

High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks)

Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks)

Usual & Customary Treatment

Outcomes

Primary Outcome Measures

Changes in Emerging Behaviors Scale (EBS) Score
The primary efficacy is measured by the Emerging Behaviors Scale (EBS) that counts the number of upper extremity skills on the hemiparetic side that the child displays (from 0 to 30). The source for observation comes from a battery of standardized age-appropriate neuromotor assessment tools (Gross Motor Function Measure-66, The Bayley III Fine and Gross Motor scales, unilateral skills during the Mini AHA) and independent observational coding of the videotaped assessment session with supplemental parent ratings on the Infant Motor Activity Log and daily skills on the MacArthur-Bates Communicative Development Inventory. A favorable outcome is defined as a gain of ≥7 new EBS skills above the child's baseline (pre-treatment) score. The EBS requires evidence of each skill from at least two independent sources.

Secondary Outcome Measures

Changes in Bilateral Use of the Hemiparetic Upper Extermity based on the Mini-Assisting Hand Assessment (Mini-AHA) play assessment
The secondary efficacy outcome is measured by increases in the use of the hemiparetic upper extremity while engaged in bilateral activities during the interactive play session of the Mini-AHA. Each item is scored on a 4-pt scale where the points are behaviorally anchored and adjusted for the child's age range. Raw scores are converted into a summary Logit score (0 to 100) based on Item Response Theory analyses, indicating the relative difficulty and sequence in which certain levels of performance appear. For this metric, higher scores are considered better.

Full Information

First Posted
April 3, 2019
Last Updated
June 26, 2023
Sponsor
Virginia Polytechnic Institute and State University
Collaborators
Ohio State University, Nationwide Children's Hospital, Stanford University, University of Cincinnati, Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03910075
Brief Title
Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
Acronym
I-ACQUIRE
Official Title
Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Virginia Polytechnic Institute and State University
Collaborators
Ohio State University, Nationwide Children's Hospital, Stanford University, University of Cincinnati, Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
The proposed study is a Phase III trial powered to determine efficacy of two different doses of I-ACQUIRE for children 8 to 36 months old with PAS and hemiparesis. The design is a prospective Randomized Controlled Trial (RCT) in which 240 children will be randomly assigned to one of 3 treatment groups (N=80 per group): 1) Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks), 2) High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks), or 3) Usual and Customary Treatment (U&CT). I-ACQUIRE will be delivered by protocol-trained therapists and monitored weekly for dosage and treatment fidelity; U&CT will be provided by community therapists with dosage and approaches documented weekly. All primary and secondary efficacy outcomes rely on blinded assessments at baseline, end of treatment, and 6 mos post-treatment. Exploratory outcomes and supplemental clinical measures may provide valuable additional data about development and health in this sample of children with PAS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Stroke, Hemiparesis
Keywords
P-CIMT, Pediatric Constraint-Induced Movement Therapy, Hemiparesis, Perinatal Stroke, Neonatal Stroke, Pediatric rehabilitation, Infant therapy, Cerebral Palsy, ACQUIRE, I-ACQUIRE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I-ACQUIRE High Dose
Arm Type
Experimental
Arm Description
High Dose I-ACQUIRE (6hrs/day, 5 days/wk X 4 wks)
Arm Title
I-ACQUIRE Moderate Dose
Arm Type
Experimental
Arm Description
Moderate Dose I-ACQUIRE (3 hrs/day, 5 day/wk X 4 wks)
Arm Title
Usual & Customary Treatment
Arm Type
Active Comparator
Arm Description
Usual & Customary Treatment
Intervention Type
Behavioral
Intervention Name(s)
I-ACQUIRE - High Dosage
Other Intervention Name(s)
ACQUIRE, Pediatric Constraint-Induced Movement Therapy, P-CIMT
Intervention Description
Children in this group will receive 6 hours of I-ACQUIRE therapy daily, 5 days a week for 4 consecutive weeks. Treatment is delivered in the home or homelike setting by a study trained I-ACQUIRE pediatric therapist.
Intervention Type
Behavioral
Intervention Name(s)
I-ACQUIRE - Moderate Dosage
Other Intervention Name(s)
ACQUIRE, Pediatric Constraint-Induced Movement Therapy, P-CIMT
Intervention Description
Children in this group will receive 3 hours of I-ACQUIRE therapy daily, 5 days a week for 4 consecutive weeks. Treatment is delivered in the home or homelike setting by a study trained I-ACQUIRE pediatric therapist.
Intervention Type
Behavioral
Intervention Name(s)
Usual & Customary Treatment (U&CT)
Intervention Description
Children in this group will receive the same U&CT that they had been receiving prior to the baseline assessment. The type and dosage of treatment(s) will be documented weekly.
Primary Outcome Measure Information:
Title
Changes in Emerging Behaviors Scale (EBS) Score
Description
The primary efficacy is measured by the Emerging Behaviors Scale (EBS) that counts the number of upper extremity skills on the hemiparetic side that the child displays (from 0 to 30). The source for observation comes from a battery of standardized age-appropriate neuromotor assessment tools (Gross Motor Function Measure-66, The Bayley III Fine and Gross Motor scales, unilateral skills during the Mini AHA) and independent observational coding of the videotaped assessment session with supplemental parent ratings on the Infant Motor Activity Log and daily skills on the MacArthur-Bates Communicative Development Inventory. A favorable outcome is defined as a gain of ≥7 new EBS skills above the child's baseline (pre-treatment) score. The EBS requires evidence of each skill from at least two independent sources.
Time Frame
Both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment
Secondary Outcome Measure Information:
Title
Changes in Bilateral Use of the Hemiparetic Upper Extermity based on the Mini-Assisting Hand Assessment (Mini-AHA) play assessment
Description
The secondary efficacy outcome is measured by increases in the use of the hemiparetic upper extremity while engaged in bilateral activities during the interactive play session of the Mini-AHA. Each item is scored on a 4-pt scale where the points are behaviorally anchored and adjusted for the child's age range. Raw scores are converted into a summary Logit score (0 to 100) based on Item Response Theory analyses, indicating the relative difficulty and sequence in which certain levels of performance appear. For this metric, higher scores are considered better.
Time Frame
Both immediately after treatment (within 7 days) and 6 months (plus or minus 2 months) post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Bateman, B.S.
Phone
540-526-2033
Email
laurapb2@vt.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie DeLuca, Ph.D.
Phone
540-526-2098
Email
Stephdeluca@vt.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon L Ramey, Ph.D.
Organizational Affiliation
Virginia Polytechnic Institute and State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Warren Lo, M.D.
Organizational Affiliation
Children's National Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
USCD Health La Jolla
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doris Trauner, MD
Phone
858-966-5819
Email
dtrauner@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Kathleen Scarvie
Phone
858-224-3204
Email
kscarvie@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Doris Trauner, MD
First Name & Middle Initial & Last Name & Degree
Jeff Gold, MD, PhD
First Name & Middle Initial & Last Name & Degree
Dylan Chen, MD, PhD
Facility Name
Yale New Haven Children's Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Ment, MD
Phone
203-785-5708
Email
laura.ment@yale.edu
First Name & Middle Initial & Last Name & Degree
Michael Kampp
Phone
203-838-1835
Email
michael.kampp@yale.edu
First Name & Middle Initial & Last Name & Degree
Laura Ment, MD
First Name & Middle Initial & Last Name & Degree
Ana Albuja, MD
First Name & Middle Initial & Last Name & Degree
Betty Vohr, MD
First Name & Middle Initial & Last Name & Degree
Tina Burton, MD
First Name & Middle Initial & Last Name & Degree
Cristina Ionita, MD
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sadie Rose, MPH
Phone
312-227-4292
Email
sgrose@luriechildrens.org
First Name & Middle Initial & Last Name & Degree
Andra Pardo, MD
Facility Name
Kennedy Krieger Institute - Fairmount Rehabilitation
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan Carney, Ed.D
Phone
443-913-4554
Email
carney@kennedykrieger.org
First Name & Middle Initial & Last Name & Degree
Jana Becker
Phone
443-923-3837
Email
beckerja@kennedykrieger.org
First Name & Middle Initial & Last Name & Degree
Joan Carney, Ed.D
First Name & Middle Initial & Last Name & Degree
Ryan Felling, MD
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Lehman, MD
Phone
617-355-2758
Email
laura.lehman@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
Julie Meadows
Phone
617-919-1446
Email
julie.meadows@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
Laura Lehman, MD
First Name & Middle Initial & Last Name & Degree
Patricia Musolino, MD
First Name & Middle Initial & Last Name & Degree
Michael Rivkin, MD
Facility Name
C.S. Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Pruente, MD
Phone
734-936-7175
Email
jpruente@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Elise Kwasniewsk
Email
ekwasnie@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Jessica Pruente, MD
First Name & Middle Initial & Last Name & Degree
Edward Hurvitz, MD
Facility Name
Washington University School of Medicine, St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alyssa Smith, MD
Email
smithalyssa@wustl.edu
First Name & Middle Initial & Last Name & Degree
Jill Newgent
Phone
314-747-3795
Email
newgentj@wustl.edu
First Name & Middle Initial & Last Name & Degree
Alyssa Smith, MD
First Name & Middle Initial & Last Name & Degree
Catherine Hoyt, PhD
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Taylor, MD
Phone
513-636-4222
Email
JM.Taylor@cchmc.org
First Name & Middle Initial & Last Name & Degree
Jessica Getz
Phone
513-803-9036
Email
jessica.getz@cchmc.org
First Name & Middle Initial & Last Name & Degree
Michael Taylor, MD
First Name & Middle Initial & Last Name & Degree
Karen Harpster, PhD/OTR/L
Facility Name
Martha Morehouse Medical Plaza
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Darragh, PhD
Phone
614-293-3760
Email
amy.darragh@osumc.edu
First Name & Middle Initial & Last Name & Degree
Petra Sternberg
Phone
614-366-7648
Email
petra.sternberg@osumc.edu
First Name & Middle Initial & Last Name & Degree
Amy Darragh, PhD
First Name & Middle Initial & Last Name & Degree
Jill Heathcock, PhD
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Prosser, PT, PhD
Phone
215-301-4301
Email
prosserl@chop.edu
First Name & Middle Initial & Last Name & Degree
Noor Ruwaih
Phone
267-426-7032
Email
ruwaihn@chop.edu
First Name & Middle Initial & Last Name & Degree
Laura Prosser, PT, PhD
First Name & Middle Initial & Last Name & Degree
Rebecca Ichord, MD
Facility Name
The Medical University of South Carolina (MUSC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patty Coker-Bolt, PhD
Email
cokerpc@musc.edu
First Name & Middle Initial & Last Name & Degree
Valerie Salisbury
Phone
843-792-8533
Email
eichbr@musc.edu
First Name & Middle Initial & Last Name & Degree
Patty Coker-Bolt, PhD
First Name & Middle Initial & Last Name & Degree
Cynthia Dodds, PhD
Facility Name
Memorial Hermann Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stuart Fraser, MD
Phone
713-500-7164
Email
Stuart.M.Fraser@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Samantha Acosta
Phone
713-500-7105
Email
Samantha.D.Acosta@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Stuart Fraser, MD
Facility Name
Fralin Biomedical Research Institute at Virginia Tech
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie DeLuca, PhD
Phone
540-526-2098
Email
stephdeluca@vt.edu
First Name & Middle Initial & Last Name & Degree
Mary Lou Schwarzer, OTA
Phone
540-526-2202
Email
mary73@vt.edu
First Name & Middle Initial & Last Name & Degree
Stephanie DeLuca, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Public use dataset from the study data will be made available.
IPD Sharing Time Frame
Approximately 1 year after primary data analysis publications
IPD Sharing Access Criteria
standard NIH criteria
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://www.nihstrokenet.org/i-acquire/resources

Learn more about this trial

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

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