NCT03034785

Flexible Electronics for Early Assessment

Young Hands at Work and Play: Flexible Electronics for Early Assessment of Force Modulation and Planning in Children Born Prematurely

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Wyss Institute at Harvard University · Academic / Other
• Sex: All
• Age: 13 Months – 60 Months
• Healthy volunteers: Accepted

Summary

The morbidities associated with very low birth weight (VLBW) infants constitute a major health problem and a significant emotional and financial burden for families and our nation. The key to reducing this burden is early diagnosis. This research will be the first step towards intervention for cerebral growth and long-term neurodevelopmental morbidities of VLBW infants. The proposed research is to design and fabricate a new technological innovation in wearable soft-sensors, called flexi-mitts, for measuring force modulation and joint angles of the hand (wrist and fingers) of toddlers. Building upon the investigators' ongoing work, they plan to engineer stretchable electronics for safe, toddler-scaled flexi-mitts to measure planning and force modulation. The investigators' new flexi-mitt technology has the potential to provide a new diagnostic technology and the development of clinical assessment norms. With additional trials of the technology in large numbers of young children, it may be possible for clinicians and day care providers to eventually make measurements of planning and force modulation in play settings.

Conditions

• Very Low Birth Weight Infant

Interventions

Type	Name	Description
DEVICE	FlexiMitt	The proposed research designs and fabricates a new technological innovation in wearable soft-sensors, called flexi-mitts, for measuring force modulation and joint angles of the hand (wrist and fingers) of toddlers.

Timeline

• Start date: 2017-08-02
• Primary completion: 2021-05-04
• Completion: 2021-05-04
• First posted: 2017-01-27
• Last updated: 2022-05-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study