1. I-ACQUIRE Blinded Assessors Welcome & General Overview
Jill Heathcock PT, PhD – Associate Professor
Amy Darragh OTR/L, PhD – Associate Professor
Thais Cabral OT, PhD – Post Doctoral Fellow
The Ohio State University

2. Introductions
Sharon Ramey (lead PI, Virginia Tech); Warren Lo (MPI, Nationwide Children’s Hospital)
Laura Bateman (Project Coordinator, Virginia Tech)
Assessment Core
Jill Heathcock – motor outcomes, reliability, monitoring
Amy Darragh – parent council, surveys, parent reported measures
Thais Cabral – central scoring, training, etc
Petra Sternberg – Bayley Kits, Toys for mini-AHA

3. I-ACQUIRE and STROKE NET
The I-ACQUIRE study is funded by NIH and
Supported by StrokeNET
There are several StrokeNET “Cores”
Imaging Core – Stanford University
National Coordinating Center – The University of Cincinnati
Data Management Core – Medical University of South Carolina (MUSC)
WebDCU
I-ACQUIRE CORES
Assessment Core – OSU
Treatment Core – Stephanie DeLuca and Craig Ramey Virginia Tech

4. Treatment I-ACQUIRE is manualized form of CIMT for Pediatric Patients
Includes whole body and bilateral training
Natural environment
Shaping, feedback, and successive approximation
I-ACQUIRE is a phase III RCT
Multisite, large sample, literature of phase I and phase III
*randomization, blinding are required parts of methodology

5. Introduction of blinded assessors -
Ann Arbor, MI
Baltimore, MD
Boston, MA
Chicago, IL
Cincinnati, OH
Cleveland, OH
Columbus, OH
Houston, TX
New Haven, CT
Philadelphia, PA
Roanoke, VA
San Diego, CA
Introduce yourself (*remember to unmute*)!
Name
Profession
Current position
Experience with:
Bayley
GMFM
Mini-AHA
Emerging Behaviors Scale
MacArthur Bates (language survey)

6. Outcome Measures Emerging Behaviors Scale
Bayley Scales of Infant Development (Bayley-III)
Gross Motor Function Measure-66 (GMFM-66)
Mini Assisting Hand Assessment (mini-AHA)
Time points
Pre-treatment, Post-treatment 1 month, Post-treatment 6 months

7. Blinded Assessors Complete the outcome measures
All sessions are videotaped and transfer to the OSU
I-ACQUIRE computer, tripod
Gross Motor Function -88(GMFM-66) – full
Bayley Scales of Infant Development (Bayley-III) – full, with modifications for R + L on FM subscale
Emerging Behaviors Scale – partial, confirmed centrally
Mini Assisting Hand Assessment (mini-AHA) – administer the play session, scored centrally.
Standardized play session
Confirming GMFCS level and mini-MAC

8. Blinded Assessors
Attend training, achieve and maintain >85% reliability on tools
Web-based training with Assessment Core (July)
Self-study (July/August)
Score videos for reliability (July/August)
Open hours for questions
chose one – 11:30 AM or 9 AM or 12 PM or PM
Send back to assessment core a child/assessor interaction + score on 1 child
Administration and score (hemiparesis preferred)
8 – 30 mo of age; photo and video release specific to your institution
Study Certified – as soon as possible given this time frame
Yearly reliability checks to avoid and correct drift

9. Recommendations Family Friendly
Schedule for AM well before or right after nap time
Home environment or in a laboratory or clinical space
Schedule assessments in back to back sessions, two days of the week (MRI literature); if everything is complete cancel the 2nd one.
Integrity of blinding
Other
Bayley Kits
MiniAHA toys
We need a name and address: please and

10. Questions

11. Parent Outcome Measures
These measures are not administered by the Assessors: parents and neurologist complete them.
Parents will bring the forms they fill out with them to each assessment.
Assessors will deliver the forms to the Research Coordinator for data entry.
Assessors can answer questions from parents about how to complete the forms

12. Parent Measures Standardized Parent Measures
Infant Motor Activity Log (IMAL)
MacArthur Bates Communicative Development Inventories (CDI-III)
Perceived Stress Scale-14
Parent Experiences and Background
Demographics
Parent Report of Other Life and Treatment Stressors
Parent Report of Therapy
Information Exchange (Parent and Therapist)
Physician Administered
Neurological Exam: Medical History and PSOM

13. I-MAL
Evaluates the infant’s frequency and quality of affected UE movement in everyday tasks.
Collected at Pre, post-test 1, post-test 2 (6 month)
Parent rates how often (never-always) & how well (poor-normal) child uses affected-UE for 20 infant arm/hand tasks.
Sample items: Hold a bottle/cup, Eat finger foods, Pick up a cylindrical object (e.g., crayon, marker, bottle, cup, or rattle).

14. MacArthur Bates Communicative Development Inventories (CDI-III)
Assesses early language skills in infants & toddlers:
(Comprehension, Vocabulary, Grammatical Skills, Nonverbal Gestures and Actions )
Collected at Pre, Post-test 1, post-test 2 (6-month)
Available for Infants and Toddlers 8 – 30 months
Forms can be completed in 20 – 45 minutes
Parents can complete at home
Available for Infants and Toddlers 8 – 30 months
Infant Form: Words and Gestures (8- to 18- months): assesses Phrases Understood, Words Understood, Words Produced, Early Gestures, Later Gestures, and Total Gestures
Toddler Form: Words and Sentences (16 – 30 months): assesses Words Produced, Irregular Words, and Mean Length of 3 Longest Sentences
Words Produced will be used for data analyses (Infant and Toddler forms both include so we can over time)

15. Perceived Stress Scale-14
Assesses perceptions of stress; specifically, the extent to which situations are perceived as stressful
Parent’s self-reported perceptions of stress are assessed at Pre-test, post-test 1, and at post-test 2.
Includes Perceived Stress Scale and Self-reported perceptions of stress
Parents complete at home
Takes 5 minutes to complete

16. Parent Measures Parent Experiences and Background
Parent Report of Other Life and Treatment Stressors
Parent Report of Therapy
Information Exchange (Parent and Therapist)

17. Parent Report of Other Life and Treatment Stressors
Assesses various sources of stress:
General Life Stress
Working, finances, health matters, concerns with immediate family, concerns with extended family/relatives
Stress Related to Treatment the child has received
Therapy meeting goals, interactions with therapist, child doesn’t like treatment, not enough/too much
Convenience of treatment
Cost of treatment
Completed Pre-test, Post-Test 1 and Post-Test 2

18. Parent Report of Therapies
Information about the therapies that the children in the study have participated in (all groups)
Completed at Pre-treatment, Post-test 1 and Post-test 2
Takes approximately 10 minutes

19. Information Exchange: Parent AND Therapist
Assesses:
Process of goal setting
Preparation and training
Role of parent in therapy
Two different forms
Completed separately by both parent and therapist during post-1 ONLY

20. Medical History Exam & Pediatric Stroke Outcome Measure
Administered by physician pre-treatment
PSOM (2 versions)
Infant
Level of consciousness, Behavior & Mental Status, Language, Cranial Nerves, infant primitive reflexes, Developmental Gross Motor, Motor Testing (power, tone, involuntary movements), tendon reflexes, fine motor, Sensory, Gait
Child over 2
Level of Consciousness, Behavior & Mental Status, Language, Cranial Nerves, Motor Exam (power, tone, involuntary movements), Tendon Reflexes, Fine Motor, Sensory, and Gait
At the end, the physician will provide his/her impressions regarding deficits in each of the tested categories

21. Schedule of Measures