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

NCT06900322 | Completed

• 1 other identifier: 2.839.838
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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.

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

ACTIVE COMPARATOR

Other: control group (conventional physical therapy)

Interventions

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.

Experimental group

control group (conventional physical therapy) OTHER

Participants kept the therapeutic routine (conventional physical therapy).

Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \[Cobb angle \> 40°\]).

Sponsors & Collaborators

• Gabriela Lopes Gama: lead

Study Sites (1)

Instituto de Pesquisa Professor Joaquim Amorim Neto

Campina Grande, Paraíba, 58406-115, Brazil

Location

MeSH Terms

Conditions

Zika Virus Infection

Interventions

Physical Therapy Modalities; Control Groups

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: March 28, 2025
• Study Start: January 15, 2018
• Primary Completion: May 8, 2018
• Study Completion: May 8, 2018
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

BR (1)