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

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

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

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

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)

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

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

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 – 7/31 @ 11:30 AM or 8/6 @ 9 AM or 8/7 @ 12 PM or 8/8 @3 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

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 email Petra.Sternberg@osumc.edu and Jill.Heathcock@osumc.edu

Questions

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

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

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).

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)

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

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

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

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

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

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

Schedule of Measures