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Impacts of a Physical Therapy Protocol on Motor Function in Children With Congenital Zika Syndrome

Structured and Specialized Physical Therapy: Does it Make a Difference for Children With Congenital Zika Syndrome?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06900322
Enrollment
16
Registered
2025-03-28
Start date
2018-01-15
Completion date
2018-05-08
Last updated
2025-03-28

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

Conditions

Congenital Zika Syndrome

Brief summary

The study aims to evaluate the effects of a specialized physiotherapy protocol aimed at the motor function of children with Congenital Zika Virus Syndrome. First, participants' anthropometric parameters (weight and length) and motor functions were assessed. After that participant were splited in two groups: Experimental group that uunderwent a one-hour daily protocol (5 times a week) of stimuli and handling based on the neuroevolutionary concept, and motor physical therapy with therapeutic garments (PediaSuit). On the other hand, the control group (CG) kept the therapeutic routine (conventional physical therapy).

Interventions

OTHERExperimental Group (stimuli and handling; physical therapy [PediaSuit])

Participants underwent a one-hour daily protocol (5 times a week) of stimuli and handling based on the neuroevolutionary concept, and motor physical therapy with therapeutic garments (PediaSuit). During therapy based in PediaSuit protocol therapy suits were used to stimulate proprioception, muscle contraction, and postural stability.Traction bands were placed on the trunk to stimulate muscle control by stabilizing this area and the antigravity muscles.The ability exercise unit was also used to stimulate postural stability and muscle resistance, according to the functional ability of each child. Neuroevolutionary concept is a problem-solving approach focused on the treatment of functional impairments, postural alignment and movement. Therefore, Neuroevolutionary concept is an individualised approach aimed at improving functionality and, consequently, the quality of life of individuals with neurological deficits.

OTHERcontrol group (conventional physical therapy)

Participants kept the therapeutic routine (conventional physical therapy).

Sponsors

Gabriela Lopes Gama
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Children with confirmed CZS diagnosis by RT-PCR or presumed by imaging findings (CT or MRI \[or both\]), and according to the Center for Disease Control and Prevention criteria * Children accompanied by the support center where the study was conducted.

Exclusion criteria

* Children who did not undergo assessments after the intervention * Children those weighing \< 9,600 kg, with uncontrolled seizures, or orthopedic changes (e.g., hip subluxations or dysplasia, severe spasticity combined with joint contractures, and severe scoliosis \[Cobb angle \> 40°\]).

Design outcomes

Primary

MeasureTime frameDescription
Gross Motor Function Measure (GMFM-88)From enrollment to the end of treatment at 12 weeksThis scale is widely used in children with neurological impairments, comprising 88 tasks divided into five dimensions: A (lying and rolling); B (sitting); C (crawling and kneeling); D (standing); and E (walking, running, and jumping). Each task received a score ranging from 0 (inability to start the task) to 3 (completes the task). Thus, the total GMFM-88 score ranged from 0 to 264 points; higher scores indicated better motor function.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026