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

G

Gabriela Lopes Gama

Status

Completed

Conditions

Congenital Zika Syndrome

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06900322
2.839.838

Details and patient eligibility

About

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).

Enrollment

16 patients

Sex

All

Volunteers

No Healthy Volunteers

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°]).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

16 participants in 2 patient groups

Experimental group
Experimental group
Treatment:
Other: Experimental Group (stimuli and handling; physical therapy [PediaSuit])
Control group
Active Comparator group
Treatment:
Other: control group (conventional physical therapy)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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