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CompletedNCT06900322Updated Mar 28, 2025

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

An interventional study of Experimental Group (stimuli and handling; physical therapy [PediaSuit]) and control group (conventional physical therapy) in Congenital Zika Syndrome, sponsored by Gabriela Lopes Gama. Completed at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2025-03-28.

Sponsored by Gabriela Lopes Gama · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 7 years 2 months after the study started (first participant enrolled Jan 2018, registered Mar 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Sex
All
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Study 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).

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Conditions studied

  • Congenital Zika Syndrome
03

In context

Zika Virus Infection

63 studies on the registry are indexed under Zika Virus Infection; 5 are open to participants now.

This study's enrollment of 16 is below the median of 85 across 34 interventional studies indexed under Zika Virus Infection.

Browse Zika Virus Infection studies →

Lead sponsor

This is the only study on the registry with Gabriela Lopes Gama as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts 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

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°]).
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Experimental group

    Other: Experimental Group (stimuli and handling; physical therapy [PediaSuit])

  • Active comparator
    Control group

    Other: control group (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).

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What researchers measure

Primary outcomes

  1. Gross Motor Function Measure (GMFM-88)

    This 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.

    Time frame: From enrollment to the end of treatment at 12 weeks

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Study locations

1 site
  • Instituto de Pesquisa Professor Joaquim Amorim Neto
    Campina Grande, Paraíba 58406-115, Brazil
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06900322
Lead sponsor
Gabriela Lopes Gama
Responsible party
Gabriela Lopes Gama (PhD, Instituto de Pesquisa Professor Joaquim Amorim Neto) — Sponsor-investigator
First posted
Mar 28, 2025
Start date
Jan 15, 2018
Primary completion
May 8, 2018
Completion
May 8, 2018
Last update
Mar 28, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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