Preterms at Risk for Developmental DisordersCareToyNCT01990183
CareToy - A Modular Smart System for Infants' Rehabilitation at Home Based on Mechatronic Toys
A study testing CareToy in people with Preterms at Risk for Developmental Disorders, run by IRCCS Fondazione Stella Maris at 2 sites in 2 countries.
Trial summary
Stroke and other neurological conditions affect the population of infants in percentages that cannot be considered marginal. Preterm infants are the highest infants at risk for neurological damage. Read more about this study
- Who is it for?
- Ages 3 to 9 monthsHealthy volunteers can take part
- Conditions the study is for
- Preterms at Risk for Developmental Disorders
- What is being tested?
- CareToy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jul 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 9 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- gestational age ≥ 28+0 weeks and 32+6 weeks
- corrected age at baseline: between 3 and 9 months;
- achievement of predefined cut off scores in gross motor ability derived from Ages \& Stages Questionnaire® Third Edition (ASQ-3), in relation to corrected age (Bricker and Squires, 1999)
- In detail:
- 4 months form (from 3 months to 4 months 30 days) score ≥ 10;
- 6 months form (from 5 months to 6 months 30 days) score ≥ 5 - < 50;
- 8 months form (from 7 months to 8 months 30 days) ≥ 10 - <30
Who cannot join
- infants with gestational age < 28 weeks or ≥ 33 weeks
- infants small for gestational age (i.e. weight below the 10th, ref)
- presence of brain damage (i.e. brain malformation, intra-ventricular haemorrhage [IVH] >1 ; any degree of periventricular leukomalacia (ref)
- known epilepsy or other form of seizure
- severe sensory deficits (blindness, deafness)
- other severe non neurological malformations
- participation in other experimental studies having rehabilitation aims
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Stroke and other neurological conditions affect the population of infants in percentages that cannot be considered marginal. Preterm infants are the highest infants at risk for neurological damage. Currently, infants have rehabilitation sessions few times a week in rehabilitation centres but according to basic neuroscience it would be necessary to provide them with an early, intensive and multiaxial intervention. One option to reduce the cost of the entire European Healthcare System while increasing the practice of rehabilitation is to devise therapies and technologies that can be administered at home by caregivers and telemonitored by rehabilitation staff. The aim of this proposal is to promote early intervention in the first year of life and to reinforce therapy by "CareToy": a portable low cost smart system telemonitored thus augmenting the clinical effectiveness of the therapy while reducing the cost. The smart system is based on a common baby gym, composed of different modules: a) an instrumented baby gym with mechatronic hanging toys, so that the infants' actions on the gym can be measured and stimulated, b) a vision module, for measuring and promoting infants' attention and gaze movements and c) a sensorized mat for measuring and promoting postural control. Each module will also incorporate built-in signal processor, memory and wireless communication. A fourth telerehabilitation module completes the system that allows the system to remotely communicate with the rehabilitation staff for monitoring and assessing the rehabilitation techniques. CareToy and the effectiveness of home rehabilitation based on this system will be validated by clinical trials on at least 50 preterm infants. The result of this project could have a large impact. CareToy may become a commercial product, manufactured on a large scale and distributed not only in rehabilitation centres but also at homes, sold or rented by the Health Care System to families as a therapeutic tool for care intensity.
Read the detailed description
Study population will be made up of premature infants recruited at the local Department of Neonatology. The eligibility of infants, i.e. children who meet the criteria for inclusion and exclusion, will be evaluated by the Neonatology team. Recruitment should take place after discharge from Neonatal Intensive Care Unit (NICU) until the age stated by inclusion criteria and will begin with the signing of the participation agreement by the parents. During the recruitment extensive perinatal data will be collected from medical records. Each clinical centre will maintain these data in an internal database storing. Every child will be evaluated on the basis of a standard neurological examination supplemented by movement analysis on video recording using Prechtl's Method Qualitative Assessment of General Movements.
The sample will be randomized in two groups in order to compare the effectiveness of the CareToy intervention program vs standard care on motor, cognitive and visual development. We designed the study as randomized clinical trial. The sample size was calculated on the basis of the primary outcome measure (Infant Motor Profile [IMP], see Outcome measures).
Before the starting of the RCT we have planned a short pilot phase where few infants in order to assess the feasibility of the CareToy training and to tune and set-up the CareToy system and the rehabilitation packages. These cases will follow the same steps planned for the RCT.
- Being tested
- CareToy, Standard Care
- Keywords
- preterm infants, early intervention, enrichment, cognitive, motor, visual development, tele-rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CareToyDevice
Infants randomized in the Intervention Group will begin the habilitation intervention immediately after evaluation at baseline. Rehabilitation staff, in accordance with each infant's needs and clinical characteristics, will set up the CareToy System to perform individualized intervention packages and its user's manual. So a personalized CareToy System will be delivered at infant's home. Moreover parents will attend a training course to use it. During each daily home - session (about 30 - 45 minutes overall) it will be proposed to the child various interactive activities in supine, prone and sitting position. The intervention phase lasts 4 weeks and each session will be remotely monitored by the rehabilitation staff.
Standard CareOther
Current care advices in the management of preterm infants in the first months of life
| Study group | Role | What they receive |
|---|---|---|
| CareToy | Experimental | CareToy intervention Receives: Device: CareToy |
| Standard Care | Other | Standard Care Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on Infant Motor Profile (IMP)
IMP is a reliable video-based assessment of motor behaviour in infancy from 3 to 18 months. It addresses to the child's motor abilities and evaluates motor behaviour in five domains: (1) variation, (2) variability (ability to select motor strategies), (3) movement fluency, (4) movement symmetry, and (5) motor performance. It has been validated in preterm and full term infants. This tool is intended to detect and quantify changes after intervention and it is reported as having a satisfactory intra and inter observer reliability and a very good concurrent validity with Alberta Infant Motor Scale and Touwen Infant Neurological Examination.
Measured: T0(baseline, 1week before beginning of Study period);T1 (within 1 week after the end of the first training/control period; before the cross-over); T2 (within 1 week after the end of the second training/control 2nd period, after cross-over), T3: 18 months
Secondary outcomes (4)
Changes on Alberta Infant Motor Scale (AIMS)
This scale examines delayed and abnormal motor development in infants overtime and is valid for assessment from term until 18 months of age. It has a good psychometric properties, it is quick to administer with limited handling and focuses on achievement of motor milestones, quality of posture and movement outcomes. Sensitivity of AIMS items has been demonstrated in differentiate preterm's infant motor development, that typically results in lower scores, and full term infants motor development.
Measured: T0 (baseline,1wk before beginning of Study period);T1(within 1 wk after end of 1st training/control period; before cross-over);T2 (within 1wk after end of 2nd training/control 2nd period, after cross-over) T3 (18 mths of corrected age)
CareToy for Clinics (CareToy C)
CareToy Evaluation Packages will be carried out using a highly equipped system, called Caretoy C in a subgroup of the enrolled infants. This evaluation is mainly composed by visual packages designed to evaluate some different infants visual abilities i.e. attention, audio-visual, fixation shift and novelty.
Measured: T0 (baseline, 1week before beginning of Study period);T1 (within 1 week after the end of the first training/control period; before the cross-over); T2 (within 1 week after the end of the second training/control 2nd period, after cross-over)
Changes on Teller Acuity Cards
Teller Acuity Cards II is a paediatric test used to evaluate visual acuity. It is based on behavioural response by judging infant's attention to a series of cards showing stripes of different widths. This tool allows rapid assessment of resolution (grating) visual acuity in infants, young children, and other populations where verbal response to recognition (letter) visual acuity charts is difficult or impossible. It evaluates infants' acuity development and it has been used in several studies for diagnostic purposes and to measure results of early intervention.
Measured: T0 (baseline,1wk before beginning of Study period);T1(within 1 wk after end of 1st training/control period; before cross-over);T2 (within 1wk after end of 2nd training/control 2nd period, after cross-over) T3 (18 mths of corrected age)
Changes on Bayley III - Cognitive subscale
his scale is sensitive in detecting differences between normative sample and children at risk for delayed development, such as premature infants. It has normative value referenced assessments, with means of 100 and Standard Deviation [SD] of 15 points. Children whose scores are 2 SDs below the normative value in a domain are considered as having a significant delay in that domain. Bayley---III is appropriate for administration to children between the ages of 1 month and 42 months (although norms extend downward to age 16 days). The Bayley III revision includes Cognitive, Language, Motor, Social-Emotional, and Adaptive Behaviour scales. Items on the cognitive subscale assess sensor-motor development, exploration, manipulation, object relatedness, concept formation, problem-solving and memory, all functions promoted during the CareToy sessions.
Measured: T0 (baseline, 1week before beginning of Study period);T3: 18 months of Corrected Age (CA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startJul 2013
- Primary completionApr 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Preterms at Risk for Developmental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Fondazione Stella Maris
- Sponsor type
- University, hospital or other
- Collaborators
- BioRobotics Institute, STMicroelectronics SRL, Italy, University of Ljubljana, University of Hamburg-Eppendorf, Fonden for Helen Elsass Center, Denmark, Marketing Research & Development SPA, Italy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990183
- Sponsor's protocol ID
- ICT-2011.5.1-287932
- Acronym
- CareToy
- Status last verified
- Feb 2016
- First submitted
- 7 Nov 2013
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rizzi R, Menici V, Cioni ML, Cecchi A, Barzacchi V, Beani E, Giampietri M, Cioni G, Sgandurra G; Clinical CareToy-R Consortium. Concurrent and predictive validity of the infant motor profile in infants at risk of neurodevelopmental disorders. BMC Pediatr. 2021 Feb 6;21(1):68. doi: 10.1186/s12887-021-02522-5.
PubMed 33549070Sgandurra G, Beani E, Inguaggiato E, Lorentzen J, Nielsen JB, Cioni G. Effects on Parental Stress of Early Home-Based CareToy Intervention in Low-Risk Preterm Infants. Neural Plast. 2019 Jan 22;2019:7517351. doi: 10.1155/2019/7517351. eCollection 2019.
PubMed 30804992Sgandurra G, Lorentzen J, Inguaggiato E, Bartalena L, Beani E, Cecchi F, Dario P, Giampietri M, Greisen G, Herskind A, Nielsen JB, Rossi G, Cioni G; CareToy Consortium. A randomized clinical trial in preterm infants on the effects of a home-based early intervention with the 'CareToy System'. PLoS One. 2017 Mar 22;12(3):e0173521. doi: 10.1371/journal.pone.0173521. eCollection 2017.
PubMed 28328946Sgandurra G, Bartalena L, Cioni G, Greisen G, Herskind A, Inguaggiato E, Lorentzen J, Nielsen JB, Sicola E; CareToy Consortium. Home-based, early intervention with mechatronic toys for preterm infants at risk of neurodevelopmental disorders (CARETOY): a RCT protocol. BMC Pediatr. 2014 Oct 15;14:268. doi: 10.1186/1471-2431-14-268.
PubMed 25319764
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CareToy - A Modular Smart System for Infants' Rehabilitation at Home Based on Mechatronic Toys
- ClinicalTrials.gov ID
- NCT01990183
- Acronym / sponsor ID
- CareToy / ICT-2011.5.1-287932
- Keywords
- preterm infants, early intervention, enrichment, cognitive, motor, visual development, tele-rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- IRCCS Fondazione Stella MarisUniversity, hospital or other
- Collaborators
- BioRobotics Institute, STMicroelectronics SRL, Italy, University of Ljubljana, University of Hamburg-Eppendorf, Fonden for Helen Elsass Center, Denmark, Marketing Research & Development SPA, Italy
- Study start
- Jul 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke and other neurological conditions affect the population of infants in percentages that cannot be considered marginal. Preterm infants are the highest infants at risk for neurological damage. Currently, infants have rehabilitation sessions few times a week in rehabilitation centres but according to basic neuroscience it would be necessary to provide them with an early, intensive and multiaxial intervention. One option to reduce the cost of the entire European Healthcare System while increasing the practice of rehabilitation is to devise therapies and technologies that can be administered at home by caregivers and telemonitored by rehabilitation staff. The aim of this proposal is to promote early intervention in the first year of life and to reinforce therapy by "CareToy": a portable low cost smart system telemonitored thus augmenting the clinical effectiveness of the therapy while reducing the cost. The smart system is based on a common baby gym, composed of different modules: a) an instrumented baby gym with mechatronic hanging toys, so that the infants' actions on the gym can be measured and stimulated, b) a vision module, for measuring and promoting infants' attention and gaze movements and c) a sensorized mat for measuring and promoting postural control. Each module will also incorporate built-in signal processor, memory and wireless communication. A fourth telerehabilitation module completes the system that allows the system to remotely communicate with the rehabilitation staff for monitoring and assessing the rehabilitation techniques. CareToy and the effectiveness of home rehabilitation based on this system will be validated by clinical trials on at least 50 preterm infants. The result of this project could have a large impact. CareToy may become a commercial product, manufactured on a large scale and distributed not only in rehabilitation centres but also at homes, sold or rented by the Health Care System to families as a therapeutic tool for care intensity.
Detailed description
Study population will be made up of premature infants recruited at the local Department of Neonatology. The eligibility of infants, i.e. children who meet the criteria for inclusion and exclusion, will be evaluated by the Neonatology team. Recruitment should take place after discharge from Neonatal Intensive Care Unit (NICU) until the age stated by inclusion criteria and will begin with the signing of the participation agreement by the parents. During the recruitment extensive perinatal data will be collected from medical records. Each clinical centre will maintain these data in an internal database storing. Every child will be evaluated on the basis of a standard neurological examination supplemented by movement analysis on video recording using Prechtl's Method Qualitative Assessment of General Movements.
The sample will be randomized in two groups in order to compare the effectiveness of the CareToy intervention program vs standard care on motor, cognitive and visual development. We designed the study as randomized clinical trial. The sample size was calculated on the basis of the primary outcome measure (Infant Motor Profile [IMP], see Outcome measures).
Before the starting of the RCT we have planned a short pilot phase where few infants in order to assess the feasibility of the CareToy training and to tune and set-up the CareToy system and the rehabilitation packages. These cases will follow the same steps planned for the RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CareToy | Experimental | Device: CareToyCareToy intervention |
| Standard Care | Other | Other: Standard CareStandard Care |
Who may qualify
- Ages
- 3 to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- gestational age ≥ 28+0 weeks and 32+6 weeks
- corrected age at baseline: between 3 and 9 months;
- achievement of predefined cut off scores in gross motor ability derived from Ages \& Stages Questionnaire® Third Edition (ASQ-3), in relation to corrected age (Bricker and Squires, 1999)
- 4 months form (from 3 months to 4 months 30 days) score ≥ 10;
- 6 months form (from 5 months to 6 months 30 days) score ≥ 5 - < 50;
Key exclusion criteria (7 listed)
- infants with gestational age < 28 weeks or ≥ 33 weeks
- infants small for gestational age (i.e. weight below the 10th, ref)
- presence of brain damage (i.e. brain malformation, intra-ventricular haemorrhage [IVH] >1 ; any degree of periventricular leukomalacia (ref)
- known epilepsy or other form of seizure
- severe sensory deficits (blindness, deafness)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CareToyInfants randomized in the Intervention Group will begin the habilitation intervention immediately after evaluation at baseline. Rehabilitation staff, in accordance with each infant's needs and clinical characteristics, will set up the CareToy System to perform individualized intervention packages and its user's manual. So a personalized CareToy System will be delivered at infant's home. Moreover parents will attend a training course to use it. During each daily home - session (about 30 - 45 minutes overall) it will be proposed to the child various interactive activities in supine, prone and sitting position. The intervention phase lasts 4 weeks and each session will be remotely monitored by the rehabilitation staff. | Device | CareToy |
| Standard CareCurrent care advices in the management of preterm infants in the first months of life | Other | Standard Care |
Primary outcome
Changes on Infant Motor Profile (IMP)
Time frame: T0(baseline, 1week before beginning of Study period);T1 (within 1 week after the end of the first training/control period; before the cross-over); T2 (within 1 week after the end of the second training/control 2nd period, after cross-over), T3: 18 months
IMP is a reliable video-based assessment of motor behaviour in infancy from 3 to 18 months. It addresses to the child's motor abilities and evaluates motor behaviour in five domains: (1) variation, (2) variability (ability to select motor strategies), (3) movement fluency, (4) movement symmetry, and (5) motor performance. It has been validated in preterm and full term infants. This tool is intended to detect and quantify changes after intervention and it is reported as having a satisfactory intra and inter observer reliability and a very good concurrent validity with Alberta Infant Motor Scale and Touwen Infant Neurological Examination.
4 secondary outcomes
Changes on Alberta Infant Motor Scale (AIMS)
Time frame: T0 (baseline,1wk before beginning of Study period);T1(within 1 wk after end of 1st training/control period; before cross-over);T2 (within 1wk after end of 2nd training/control 2nd period, after cross-over) T3 (18 mths of corrected age)
CareToy for Clinics (CareToy C)
Time frame: T0 (baseline, 1week before beginning of Study period);T1 (within 1 week after the end of the first training/control period; before the cross-over); T2 (within 1 week after the end of the second training/control 2nd period, after cross-over)
Changes on Teller Acuity Cards
Time frame: T0 (baseline,1wk before beginning of Study period);T1(within 1 wk after end of 1st training/control period; before cross-over);T2 (within 1wk after end of 2nd training/control 2nd period, after cross-over) T3 (18 mths of corrected age)
Changes on Bayley III - Cognitive subscale
Time frame: T0 (baseline, 1week before beginning of Study period);T3: 18 months of Corrected Age (CA)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
- Derived from this study: PubMed 33549070Rizzi R, Menici V, Cioni ML, Cecchi A, Barzacchi V, Beani E, Giampietri M, Cioni G, Sgandurra G; Clinical CareToy-R Consortium. Concurrent and predictive validity of the infant motor profile in infants at risk of neurodevelopmental disorders. BMC Pediatr. 2021 Feb 6;21(1):68. doi: 10.1186/s12887-021-02522-5.
- Derived from this study: PubMed 30804992Sgandurra G, Beani E, Inguaggiato E, Lorentzen J, Nielsen JB, Cioni G. Effects on Parental Stress of Early Home-Based CareToy Intervention in Low-Risk Preterm Infants. Neural Plast. 2019 Jan 22;2019:7517351. doi: 10.1155/2019/7517351. eCollection 2019.
- Derived from this study: PubMed 28328946Sgandurra G, Lorentzen J, Inguaggiato E, Bartalena L, Beani E, Cecchi F, Dario P, Giampietri M, Greisen G, Herskind A, Nielsen JB, Rossi G, Cioni G; CareToy Consortium. A randomized clinical trial in preterm infants on the effects of a home-based early intervention with the 'CareToy System'. PLoS One. 2017 Mar 22;12(3):e0173521. doi: 10.1371/journal.pone.0173521. eCollection 2017.
- Derived from this study: PubMed 25319764Sgandurra G, Bartalena L, Cioni G, Greisen G, Herskind A, Inguaggiato E, Lorentzen J, Nielsen JB, Sicola E; CareToy Consortium. Home-based, early intervention with mechatronic toys for preterm infants at risk of neurodevelopmental disorders (CARETOY): a RCT protocol. BMC Pediatr. 2014 Oct 15;14:268. doi: 10.1186/1471-2431-14-268.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CareToy in people with Preterms at Risk for Developmental Disorders, run by IRCCS Fondazione Stella Maris at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on Infant Motor Profile (IMP) (time frame: T0(baseline, 1week before beginning of Study period);T1 (within 1 week after the end of the first training/control period; before the cross-over); T2 (within 1 week after the end of the second training/control 2nd period, after cross-over), T3: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01990183, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2016.