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Comparison of an Online and Face-to-face Motor Program for infants with Delayed Motor Development

Online and Face-to-Face Program to Improve Motor Development in infants with Delay in Motor Development due to Neurological Injury: a non-randomized controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3vhw2hx
Enrollment
Unknown
Registered
2023-03-07
Start date
2023-03-10
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

cerebral palsy

Interventions

The study will be controlled and randomized. After recruitment, researchers will contact those who agree to participate by telephone. Caregivers will receive explanations about study aims and methods
b) four sessions held by caregivers without therapist supervision, in their homes, 30 minutes per session. The expected total dosage will be 2160 minutes (60 minutes once a week of supervised sessions
for a total of 12 weeks). In
E02.779

Sponsors

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

Eligibility

Inclusion criteria

Inclusion criteria: Infants at risk for delayed neuromotor development; aged between three and 18 months of corrected age; infants with a risk factor for delayed neuromotor development; including deficits in neurological function according to standardized scales (the General Movements Assessment and a neurological assessment using some items of the Hammersmith Infant Neurological Examination); brain lesions determined by neuroimaging when possible; and delayed motor development (percentile below 25) assessed by the Alberta Infant Motor Scale (AIMS)

Exclusion criteria

Exclusion criteria: Severe genetic abnormalities; hospitalized infants; presence of blindness or deafness; changes in the skin; clinical diagnosis of respiratory diseases; presence of congenital diseases; such as heart disease, renal or ophthalmological alterations; physiologically unstable infants

Design outcomes

Primary

MeasureTime frame
It is expected to find that the telerehabilitation program will be similarly viable to the face-to-face program in terms of recruitment, assessed by retention rate, lost rate, final retention rate, and final lost rate. Data collected at the end of the intervention, from diaries filled in by caregivers and therapists;It is expected to find that the telerehabilitation program will be viable in a similar way to the face-to-face program in terms of evaluation, assessed through the description of the number of infants who completed the evaluation, the number of infants who felt some discomfort or adverse events and the type of adverse effects, for each assessment instrument. Data collected at the end of the intervention, from diaries filled in by therapists;It is expected to find that the telerehabilitation program will be viable in a similar way to the face-to-face program in terms of intervention, assessed through adherence to the intervention program determined by comparing the number of weeks of rehabilitation, number of days per week, duration of rehabilitation per week and the total number of days of intervention expected and applied; number of withdrawals with their reasons; number of days on which the rehabilitation was not applied with its reasons; number of infants who had adverse effects, dropouts due to adverse effects, and types of adverse effects. Data collected at the end of the intervention, from diaries filled in by caregivers;It is expected to find that the telerehabilitation program will have lower financial expenses than the face-to-face program, evaluated by family expenses with the provision of materials for the telerehabilitation program, family expenses with displacement and expenses with the therapist. Data collected at the end of the intervention, from diaries filled in by therapists

Secondary

MeasureTime frame
It is expected that the telerehabilitation group will have scores similar to the face-to-face group for gross motor function, assessed using the Gross Motor Function Measure. Data collected one week before the intervention and at the end of the intervention (12 weeks);It is expected that the telerehabilitation group will have scores similar to the face-to-face group for motor goals, assessed using the Goal Attainment Scale T-score. Data collected one week before the intervention and at the end of the intervention (12 weeks);It is expected that the telerehabilitation and face-to-face groups will similarly present low levels of stress, anxiety and depression, assessed using the Depression, Anxiety, Stress Scales-21. Data collected one week before the intervention and at the end of the intervention (12 weeks);It is expected that the telerehabilitation group will have similar scores to the face-to-face group for motor development, assessed using the Alberta Infant Motor Scale. Data collected one week before the intervention and at the end of the intervention (12 weeks)

Countries

Brazil

Contacts

Public ContactAdriana Neves dos Santos

Universidade Federal de Santa Catarina

adrianaft04@gmail.com+55(48)3721-6255

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Apr 11, 2026