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?

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).

Study Overview

• Status: Completed
• Conditions: Congenital Zika Syndrome
• Intervention / Treatment: Other: Experimental Group (stimuli and handling; physical therapy [PediaSuit]); Other: control group (conventional physical therapy)

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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°]).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group	Other: control group (conventional physical therapy); Participants kept the therapeutic routine (conventional physical therapy).
Experimental: Experimental group	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Gabriela Lopes Gama

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): May 8, 2018
• Study Completion (Actual): May 8, 2018

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): March 28, 2025

Study Record Updates

• Last Update Posted (Actual): March 28, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vector Borne Diseases; Mosquito-Borne Diseases; Pathologic Processes; Infections; RNA Virus Infections; Virus Diseases; Disease; Arbovirus Infections; Flavivirus Infections; Flaviviridae Infections; Zika Virus Infection; Syndrome
• Other Study ID Numbers: 2.839.838

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No