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Effect of Task-Oriented Therapy, motor enrichment (Time-Baby) on motor development of infants at biological risk for neurodevelopmental delay: Randomized controlled clinical trial

Effect of Task-Oriented Therapy associated with environmental enrichment on the motor development of infants at biological risk for neurodevelopmental disorders: Randomized controlled clinical trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2nktkhd
Enrollment
Unknown
Registered
2024-08-26
Start date
2024-03-04
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Other preterm newborns. Birth asphyxia unspecified. Other low birth weight newborns

Interventions

This is a randomized controlled clinical trial, with infants aged between 3 and 6 months, and considered to be at biological risk by the Ministry of Health, that is, who meet one of the following crit

Sponsors

Centro de Ciências Biológicas e da Saude - CCBS
Lead Sponsor
Universidade Federal de São Carlos - UFSCAR
Collaborator

Eligibility

Age
3 Months to 6 Months

Inclusion criteria

Inclusion criteria: Infants of both sexes, aged between 3 and 6 months corrected age, who are considered to be at biological risk by the Ministry of Health, i.e., who present one of the following criteria, will be included in the study: 1) prematurity (<37 weeks of gestational age); 2) low birth weight (<2500 g); 3) Asphyxia (Apgar <7 at 5 min); and the acceptance of the parents and/or legal guardians will be required, by means of signing the Free and Informed Consent Form (TCLE)

Exclusion criteria

Exclusion criteria: Infants who do not present at least one of the criteria for biological risk factors; those who present decompensated respiratory and/or cardiac dysfunctions; parents who present any cognitive or motor impairment that prevents understanding and carrying out the intervention; and infants who do not attend the evaluations will not be included in the study

Design outcomes

Primary

MeasureTime frame
It is expected that the group that received the TIME-Baby intervention will have an improvement in motor development, that is, better scores in the motor performance domain of the Infant Motor Scale (IMP) and Alberta Infant Motor Scale (AIMS). Furthermore, it is expected that after treatment, parents and/or guardians in the experimental group will attribute better scores (inter and intragroups) on the performance and satisfaction items of the Canadian Occupational Performance Measure (COPM) scale.

Secondary

MeasureTime frame
No secondary outcomes are expected.

Countries

Brazil

Contacts

Public ContactVitoria Urruchia

Universidade Federal de São Carlos - UFSCAR

vitoriaurruchia@gmail.com+55 (17) 992232485

Outcome results

None listed

Source: REBEC (via WHO ICTRP)