Motorische training voor zuigelingen met hersenverlamming
Motorische trainingsinterventie voor baby's met een hoog risico op hersenverlamming: haalbaarheid en aanvaardbaarheid
The intervention in this study, Let's Move, is a motor intervention for infants at risk for cerebral palsy. We will test the feasibility and acceptability of the intervention as well as preliminary effectiveness.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The aims of this study are to test the feasibility, acceptability, and operationalize a novel motor intervention, called "Let's Move" delivered using a combined clinic and home (video telehealth) therapy model.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Karen Harpster, PhD, OTR/L
- Telefoonnummer: 513-803-3604
- E-mail: karen.harpster@cchmc.org
Studie Contact Back-up
- Naam: Nehal A Parikh, DO, MS
- Telefoonnummer: 513-517-1044
- E-mail: nehal.parikh@cchmc.org
Studie Locaties
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45229
- Werving
- Cincinnati Children's Hospital Medical Center
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Contact:
- Nehal A Parikh, DO, MS
- Telefoonnummer: 513 517-1044
- E-mail: nehal.parikh@cchmc.org
-
Contact:
- Karen L Harpster, PhD, OTR/L
- Telefoonnummer: 513-803-3604
- E-mail: karen.harpster@cchmc.org
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
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Age at enrollment: between 3-8 months corrected age
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Caregivers fluent in English
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Preterm infants with objectively defined severe diffuse white matter abnormality on MRI at term OR
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High-risk infants (e.g., preterm, neonatal hypoxic-ischemic encephalopathy, perinatal stroke) with moderate-severe injury on structural MRI or cranial ultrasound (e.g., basal ganglia/thalamic signal intensity, cystic periventricular leukomalacia, encephalomalacia, large stroke, and/or severe intraventricular/periventricular hemorrhage) at around term-equivalent age or before Neonatal Intensive Care Unit discharge AND either:
- "Absent" fidgety movements based on the Prechtl General Movement Assessment (GMA) between 3-4 months corrected age OR
- A score of 56 or below on the Hammersmith Infant Neuromotor Examination (HINE) between 3-6 months corrected age (31)
Exclusion Criteria:
- Medical conditions that restrict active participation such as oxygen dependence
- Infants with significant visual deficits defined by the inability to track an object horizontally
- Living in a remote location prohibiting drives to the hospital every other week.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Control group
Infants randomized to the usual care arm will receive usual care for 4 months. Therapy services provided to infants at this age vary in terms of frequency, location, and provider. Usual care is prescribed by the child's primary care provider (PCP), and in this population, usual care typically consists of one or both of the following: Early intervention therapy services provided by the state or Therapy in an outpatient clinic. Control group participants will be offered the Let's Move interventions after 16 weeks of control group. |
Let's Move intervention will be administered and videotaped with infant/caregiver dyads. Therapy will occur weekly (30-60 minutes per session) for 16 weeks, alternating between clinic and home (video telehealth) sessions. Each month, we will attempt to schedule two clinic-based sessions followed by 2 telehealth-based sessions |
|
Experimenteel: Intervention group: Let's Move
Infants randomized to the Let's Move intervention group will be scheduled for therapy one time per week for 16 sessions (approximately 30-60 minutes per session). The intervention setting will involve both in-person (CCHMC clinic or in-home) and telehealth (in-home, video-based) sessions. The therapist will provide the caregivers with home programs to complete between therapy sessions (5 days per week). The home program will be based on the infant's goals set collaboratively between the caregiver and the evaluating therapist at the baseline assessment using the Canadian Occupational Performance Measure (COPM). At least half of the intervention sessions will be video recorded to assess feasibility and monitor intervention fidelity. |
Let's Move intervention will be administered and videotaped with infant/caregiver dyads. Therapy will occur weekly (30-60 minutes per session) for 16 weeks, alternating between clinic and home (video telehealth) sessions. Each month, we will attempt to schedule two clinic-based sessions followed by 2 telehealth-based sessions |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change on Peabody Developmental Scales - Second Edition before and after intervention and follow-up
Tijdsspanne: Baseline,16 weeks, 28 weeks
|
Motor test |
Baseline,16 weeks, 28 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change on Pediatric Evaluation of Disability Inventory-Computer Adaptive Test before and after intervention and follow-up
Tijdsspanne: Baseline,16 weeks, 28 weeks
|
Parent reported test for functional performance |
Baseline,16 weeks, 28 weeks
|
|
Change on Canadian Occupational Performance Measure before and after intervention and follow-up
Tijdsspanne: Baseline,16 weeks, 28 weeks
|
Caregivers perception of child's performance on functional goals |
Baseline,16 weeks, 28 weeks
|
|
Change on Hammersmith Infant Neurological Exam before and after intervention and follow-up
Tijdsspanne: Baseline,16 weeks, 28 weeks
|
Neurological exam |
Baseline,16 weeks, 28 weeks
|
|
Preverbal visual assessment (PreViAs
Tijdsspanne: Enrollment, 4 months later, 8 months later
|
Screening tool for the development of visual maturation |
Enrollment, 4 months later, 8 months later
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Karen Harpster, PhD, OTR/L, Children's Hospital Medical Center, Cincinnati
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2021-0305
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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