Creating Mobility-supported Home Play Environments to Enhance Development in Infants With Down Syndrome (HOME)
Harnessing Opportunities for Mobility and Exploration (HOME): Creating Mobility-supported Home Play Environments to Enhance Development in Infants With Down Syndrome
Infants with Down syndrome (DS) exhibit early developmental delays in motor skills and multiple other domains. Once infants are upright and moving, they have new opportunities for exploring the environment and interacting with objects and people that are important for early learning and development. This project will allow the investigators to assess the feasibility of a home-based mobility and play intervention for infants with DS (using a body weight supported harness system- Portable Mobility Use Aid (PUMA) for Children and characterize its impact on promoting mobility, exploration, and play with objects and caregivers. PUMA is a specialized pediatric partial body-weight support system designed to give children with developmental delays or physical disabilities the upright support they need to move, explore, and play independently.
Studieoversikt
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Jana M Iverson, PhD
- Telefonnummer: 617.358.5480
- E-post: iversonj@bu.edu
Studer Kontakt Backup
- Navn: Audrey Lorence, BS
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forente stater, 02215
- Charles River Campus, Boston University
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Ta kontakt med:
- Jana M Iverson, PhD
- Telefonnummer: 617-358-5480
- E-post: iversonj@bu.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Infants/toddlers inclusion criteria
- confirmed diagnosis of Down syndrome;
- able to sit without support and not yet taking any independent steps
Primary caregiver inclusion criteria
- proficient in English
- has access to a computer, tablet or mobile phone with a camera and microphone
- has access to zoom
Infants/toddlers exclusion criteria:
- severe, uncontrolled medical problems (including heart disease with cardiovascular instability, uncontrolled epilepsy)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Portable Mobility Use Aid (PUMA) system for Children playtime
The investigators will deliver a Portable Mobility Use Aid (PUMA) system for Children playtime to the home and assist caregivers with setup. |
Families will be asked to use the PUMA system with their infant 5 days/week for a minimum of 30 min (longer is permitted) for one month. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Infant upright postures
Tidsramme: baseline, 2 weeks, 1 month, 6 months, 12 months
|
This outcome will be assessed by the proportion of time the infant spends in an upright posture |
baseline, 2 weeks, 1 month, 6 months, 12 months
|
|
Infant locomotion
Tidsramme: baseline, 2 weeks, 1 month, 6 months, 12 months
|
This outcome will be assessed by the proportion of time the infant spends in locomotion |
baseline, 2 weeks, 1 month, 6 months, 12 months
|
|
Infant initiated proximity changes
Tidsramme: baseline, 2 weeks, 1 month, 6 months, 12 months
|
This outcome will be assessed by the proportion of Infant initiated proximity changes |
baseline, 2 weeks, 1 month, 6 months, 12 months
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|
Joint object play bouts
Tidsramme: baseline, 2 weeks, 1 month, 6 months, 12 months
|
This outcome will be assessed by the proportion of joint object play bouts |
baseline, 2 weeks, 1 month, 6 months, 12 months
|
|
Infant-initiated proximity
Tidsramme: baseline, 2 weeks, 1 month, 6 months, 12 months
|
This outcome will be assessed by the proportion of infant-initiated proximity |
baseline, 2 weeks, 1 month, 6 months, 12 months
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jana M Iverson, PhD, Physical Therapy, Sargent College, Charles River Campus Boston University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 8756
- R01HD120575 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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