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

NCT ID: NCT06900322

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-15
• Study Completion Date: 2018-05-08

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).

Conditions

Congenital Zika Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental group

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

control group (conventional physical therapy)

Intervention Type: OTHER

Participants kept the therapeutic routine (conventional physical therapy).

Interventions

Experimental 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.

Intervention Type: OTHER

control group (conventional physical therapy)

Participants kept the therapeutic routine (conventional physical therapy).

Intervention Type: OTHER

Eligibility Criteria

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°]).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gabriela Lopes Gama

OTHER

Sponsor Role: lead

Responsible Party

Gabriela Lopes Gama

PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Instituto de Pesquisa Professor Joaquim Amorim Neto

Campina Grande, Paraíba, Brazil

Countries

Brazil

Other Identifiers

2.839.838

Identifier Type: -

Identifier Source: org_study_id