CompletedNot Applicable

SmarToyGym: Smart Detection of Atypical Toy-oriented Actions in At-risk Infants

United States36 participantsStarted 2015-05

Plain-language summary

The study aims to develop a SmarToyGym where sensitized, wireless toys are strategically hung and placed within reach of infants to elicit toy-oriented body and arm/hand movements. Each toy will be equipped with sensors capable of measuring the infant's grasping actions such as squeezing, pinching, tilting, etc. A low-cost 3D motion capture system will be used to collect video data and the infants' reaching and body kinematics in response to the toys. A pressure mat will be used to measure postural changes to detect weight shifts, rolling, crawling and other movements away from the initial posture. By capitalizing on these wireless and low-cost technologies, it will permit the regular and non-invasive monitoring of infants, which can lead to detailed, non-obtrusive, quantitative evaluation of motor development. In this vein, the investigators also aim to conduct proof-of-concept testing of the SmarToyGym with atypical and typical developing infants. The investigators will include infants' ages 3 to 11 months who are categorized as high-risk or low-risk using the Bayley Infant Neurodevelopmental Screener.

Who can participate

Age range

3 Months – 11 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Infants exhibiting typical development between 3 months and 11 months of age who score in the low-risk category on the Bayley Infant Neurodevelopment Screener (BINS), score greater than 85 on all sub-scales of the Bayley Scale of Infant Development (BSID-II), have no history of significant cardiac, orthopedic or neurological condition and have a gestational age at least 37 weeks. * Infants exhibiting atypical development (at-risk for neuromotor delay) between 3 months and 11 months of age, score in the moderate or high risk categories on the BINS, and score an 85 or less on the motor sub-scales of the BSID-II. * Exclusion Criteria: * Infants outside age range of 3-11 months

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Center of Pressure, Path Length Per Second - No Toy (Birth Status)

Timeframe: 1 session, about 1 hour in length

Center of Pressure, Path Length Per Second - Elephant Toy (Birth Status)

Timeframe: 1 session, about 1 hour in length

Center of Pressure, Path Length Per Second - Orangutan Toy (Birth Status)

Timeframe: 1 session, about 1 hour in length

Center of Pressure, Path Length Per Second - Lion Toy (Birth Status)

Timeframe: 1 session, about 1 hour in length

Center of Pressure, Path Length Per Second - No Toy (Motor Control Outcome)

Timeframe: 1 session, about 1 hour in length

Center of Pressure, Path Length Per Second - Elephant Toy (Motor Control Outcome)

Timeframe: 1 session, about 1 hour in length

Center of Pressure, Path Length Per Second - Orangutan Toy (Motor Control Outcome)

Trial details

NCT IDNCT02813889

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08-30

Results submitted2023-02-22

View on ClinicalTrials.gov More Cerebral Palsy trials

Plain-language summary

Who can participate

Age range

3 Months – 11 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Center of Pressure, Path Length Per Second - No Toy (Birth Status)

Timeframe: 1 session, about 1 hour in length

Center of Pressure, Path Length Per Second - Elephant Toy (Birth Status)

Timeframe: 1 session, about 1 hour in length

Center of Pressure, Path Length Per Second - Orangutan Toy (Birth Status)

Timeframe: 1 session, about 1 hour in length

Center of Pressure, Path Length Per Second - Lion Toy (Birth Status)

Timeframe: 1 session, about 1 hour in length

Center of Pressure, Path Length Per Second - No Toy (Motor Control Outcome)

Timeframe: 1 session, about 1 hour in length

Center of Pressure, Path Length Per Second - Elephant Toy (Motor Control Outcome)

Timeframe: 1 session, about 1 hour in length

Center of Pressure, Path Length Per Second - Orangutan Toy (Motor Control Outcome)