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Functional training in natural environments for children and adolescents with cerebral palsy and Down syndrome

Functional mobility training in a naturalistic environment through the TREINI Program for children and adolescents with Cerebral Palsy and Down Syndrome: a randomized clinical trial protocol

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5m59v54
Enrollment
24
Registered
2026-05-20
Start date
2026-04-17
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Cerebral Palsy

Interventions

This is a two-arm, randomized controlled clinical trial with blinded assessors. Experimental group: 12 individuals with cerebral palsy or Down syndrome will receive occupational therapy intervention t
s inclusion in the study

Sponsors

Instituto de Neurodesenvolvimento, Cognição e Educação Inclusiva
Lead Sponsor
Faculdade de Ciências Médicas de Minas Gerais
Collaborator

Eligibility

Age
5 Years to 18 Years

Inclusion criteria

Inclusion criteria: Participants diagnosed with Cerebral Palsy (CP); aged between 5 and 18 years; both sexes; classified in levels I, II, III or IV of the Gross Motor Function Classification System or diagnosed with Down Syndrome (DS)

Exclusion criteria

Exclusion criteria: Participants who are unable to complete baseline assessments; who have undergone orthopedic or neurological surgery within 6 months prior to study recruitment; or who have cognitive, behavioral, or medical impairments that prevent them from safely following instructions and participating in activities proposed in the intervention, or who do not tolerate wearing the garment, are ineligible

Design outcomes

Primary

MeasureTime frame
An improvement is expected in functional performance as assessed by the mobility domain of the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT);The goal is to achieve the objectives set by the family, related to motor skills, as assessed by the Canadian Occupational Performance Measure;Improvements in functional mobility are expected, as assessed by the Timed Up and Go test

Secondary

MeasureTime frame
Improvement in gross motor function, as assessed by the Gross Motor Function Measure, is expected;An improvement is expected in the ability to transition from a seated to a standing position, as assessed by the five-repetition sit-to-stand test

Countries

BR

Contacts

Public ContactAmanda Nascimento

Instituto de Neurodesenvolvimento, Cognição e Educação Inclusiva

amanda.aacn@gmail.com+5531999147360

Outcome results

None listed

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