Implementation and acceptability of PUMA Playtime intervention for toddlers with Down syndrome: a feasibility study.

PURPOSE: Caregiver-delivered interventions that support mobility may provide an opportunity for high-dosage practice and promote overall development for infants and toddlers with Down syndrome (DS). This single-arm feasibility study examined the implementation and acceptability of a home-based open-area partial body-weight support system intervention with the Portable Mobility Aid (PUMA, Enliten LLC) for toddlers with DS and their caregivers. A secondary analysis explored motor skills practiced and play partners during PUMA Playtime. MATERIALS AND METHODS: Six toddlers with DS (3 M/3F, Age 16.44-24.92 months) who were not yet walking independently and their caregivers completed this home-based trial. Participants were instructed to use the PUMA system for 30 min per day, 5 days per week over 4 weeks and reported their usage through a daily survey. Successful implementation was measured as adherence rates >80%. Acceptability was measured using four 11-point Likert-type scales following the intervention. RESULTS: Four of six families completed at least 95% of prescribed days (45 - 115%), and all participants averaged at least 28 min per day of use (28 - 38 min). Caregivers reported the PUMA was easy to use on their own, and that PUMA Playtime impacted their toddler's motor skills and provided benefit to their toddler. During PUMA Playtime, toddlers consistently practiced novel skills and multiple family members joined playtime. CONCLUSION: This feasibility study suggests that a home-based open-area partial body-weight support system intervention can be successfully implemented and is acceptable for toddlers with DS and their caregivers. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT06219863.