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

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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Key information

Conditions

Congenital Zika Syndrome Arbovirus Infections Flaviviridae Infections Flavivirus Infections Infections Mosquito-Borne Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases Zika Virus Infection

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Pesquisa Professor Joaquim Amorim Neto

Campina Grande, Paraíba, 58406-115, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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°]).

Treatment and study plan

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

Other

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.

control group (conventional physical therapy)

Other

Participants kept the therapeutic routine (conventional physical therapy).

Primary outcomes

Gross Motor Function Measure (GMFM-88)

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

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.

Sponsors and collaborators

Lead sponsor

Gabriela Lopes Gama

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Mar 28, 2025
Registry last updated: Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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