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Effects of home guidance provided by parents on the functionality of infants at biological risk

Tele-care protocol performed by parents involving specific task- environment- participation (STEP protocol) for infants at risk for cerebral palsy- randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8xrzjs
Enrollment
Unknown
Registered
2020-09-01
Start date
2020-07-01
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

Infants with conditions originating in the perinatal period: - Other preterm infants - Extremely low birth weight - Birth asphyxia, unspecified

Interventions

The main intervention of the study will be carried out through guidelines of physical therapy activities, to be performed by parents in the home environment, focused on the task and the context. The g
2) functional tasks and 3) guidance to parents (participation, mother-child interaction and environmental enrichment). The selection of functional tasks will occur according to the objectives previous
E02.779
E02.760.190.203

Sponsors

Universidade Federal de São Carlos
Lead Sponsor
Universidade Federal de São Carlos
Collaborator

Eligibility

Age
3 Months to 12 Months

Inclusion criteria

Inclusion criteria: Infants aged 3 to 12 months of corrected age will be included; of both sexes; with moderate to high risk for developmental delay. Moderate to high risk infants will be considered to be those who meet at least one of the following criteria, being they born before 33 weeks of gestational age; weight below the 10th percentile according to gestational age and sex; Apgar score from 0 to 3 for more than 5 minutes; neurological manifestations in the neonate such as seizures, coma or hypotonia; need for cardiorespiratory resuscitation or use of oxygen therapy; prolonged hospital stay in the Intensive Care Unit; presence of abnormal General movements.

Exclusion criteria

Exclusion criteria: Infants over 12 months of age will not be included in the study; no risk of developmental delay; who have diagnosed primary diseases and congenital diseases; autism; Down's syndrome; muscular dystrophies; heart diseases; renal changes; bone deformities; confirmed blindness or deafness; infants with severe respiratory diseases; epilepsy or frequent seizures.

Design outcomes

Primary

MeasureTime frame
Expected primary outcome 1: improvement in motor skills, assessed by the Infant Motor Profile scale (total score), through an increase of at least 15% of the total value of the scale score. Data collected 1 week before the intervention and 10 weeks after the start of the intervention.;Expected primary outcome 2: improvement in motor skills, assessed by the Alberta Infant Motor Scale, through the addition of the infant's percentile. Data collected 1 week before the intervention and 10 weeks after the start of the intervention.

Secondary

MeasureTime frame
Expected secondary outcome 2: improvement in participation, assessed by the Young Children’s Participation and Environment Measure scale, by increasing the scale's total participation score by 15%. Data collected 1 week before the intervention and 10 weeks after the start of the intervention.;Expected secondary outcome 1: improvement in mother-child interaction, assessed using the Parent-Child Early Relational Assessment scale, by increasing the scale's total score by 10%. Data collected 1 week before the intervention and 10 weeks after the start of the intervention.;Expected secondary outcome 3: increase in opportunities available in the home environment, assessed by the Affordances in the Home Environment for Motor Development scale, by increasing the scale's total score by 10%. Data collected 1 week before the intervention and 10 weeks after the start of the intervention.

Countries

Brazil

Contacts

Public ContactCamila Lima

Universidade Federal de São Carlos

camillinha_gambaro@hotmail.com+55-11-957838540

Outcome results

None listed

Source: REBEC (via WHO ICTRP)