Efficacy of Aquatic Physiotherapy in Children With Microcephaly by Zika Virus Congenital Syndrome

NCT03330600 | Completed

• 1 other identifier: Projeto Milena LEPed
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Microcephaly associated with Congenital Syndrome of the Zika virus (SCVZ) was highlighted due to atypical structural and behavioral changes of the central nervous system. Such changes contribute to the appearance of functional impairments and difficulties of adaptation of the child to the necessary therapeutic follow-up. In this context, the search for adjuvant therapies that allow better management of these alterations has grown and, given its advantages, aquatic physiotherapy may be an auxiliary resource in the care of this population. The aquatic environment is capable of promoting a state of relaxation that, when associated with a kinesiotherapy protocol, is believed to have this potentiated effect. Thus, our objective will be to evaluate the efficacy of aquatic physiotherapy on the level of stress and muscle tone in children with microcephaly associated with SCVZ. A crossover, randomized, controlled and blind study will be carried out with children between 3 and 24 months of age, who will undergo two interventions: aquatic physiotherapy and water immersion. The evaluation of muscle tone will be performed through the Tardieu scale before and after the intervention; the physiological parameters (heart and respiratory rate, oxygen saturation and temperature) and the stress level will be evaluated before, immediately after and 30 minutes after the intervention. In addition, questionnaires will assess the child's behavioral state, level of irritation and sleep characteristics. For data normalization the Shapiro Wilk Test will be applied; the percentage values and relative frequency will be used for the descriptive analysis and for the numerical variables the values of mean and standard deviation or median and interquartile range. The paired T and ANOVA tests for repeated samples will be applied, which will analyze the intra-group time factor for the dependent variables of each individual. And for intergroup analysis, the variables may be submitted to the T-Test for independent or Mann-Whitney samples.

Conditions

Zika Virus Infection; Microcephaly

Outcome Measures

Primary Outcomes (1)

• change in Modified Tardieu Scale

  assessment muscle tone at 5 degrees (0 = no resistance, 1 = slight resistance, no specific angle, 2 = moderate resistance with specific reaction angle, 3 = light clone, for less than 10 seconds, 4 = clusions for more than 10 seconds, 5 = immobile articulation). In addition to measuring the increase or decrease in the range of motion of each joint.

  baseline and up 30 minutes

Secondary Outcomes (4)

• change in heart rate

  baseline and up 30 minutes

• change in respiratory frequency

  baseline and up 30 minutes

• change in oxygen saturation

  baseline and up 30 minutes

• change in body temperature

  baseline and up 30 minutes

Study Arms (2)

aquatic physicotherapy group

EXPERIMENTAL

For the experimental group, we will associate kinesiotherapy with immersion in water.

Behavioral: aquatic physicotherapy; Behavioral: immersion

immersion group

PLACEBO COMPARATOR

The control group will be submitted to immersion in the water, contained in flexion with the towel and maintaining the same care as the experimental one.

Behavioral: aquatic physicotherapy; Behavioral: immersion

Interventions

aquatic physicotherapy BEHAVIORAL

Aquatic physiotherapy will be performed in a bathtub with water heated to a temperature around 37º C and environment with adequate temperature and luminosity. Kinesiotherapy will begin with smooth sliding movements in the aquatic environment, still in flexor restraint, allowing the child to adapt to the temperature of the new environment; joint mobilizations will be initiated on the shoulders and hips followed by stretching of the accessory muscles of the breath, spine erector, flexor and extensors of shoulder, elbow, hip, knee and ankle. The sessions will last 10 minutes and may be interrupted if the child shows signs of discomfort such as cyanosis, increased respiratory rate, bronchoaspiration or does not adapt to the environment, ie, remain crying for more than 5 minutes.

Also known as: hydrotherapy

aquatic physicotherapy group; immersion group

immersion BEHAVIORAL

The immersion will be performed in a bathtub with water heated to a temperature around 37º C and environment with adequate temperature and luminosity. The therapy will begin with smooth sliding movements in the aquatic environment, still in flexor restraint, allowing the child to adapt to the temperature of the new environment. The sessions will last 10 minutes and may be interrupted if the child shows signs of discomfort such as cyanosis, increased respiratory rate, bronchoaspiration or does not adapt to the environment, ie, remain crying for more than 5 minutes.

Also known as: hydrotherapy

aquatic physicotherapy group; immersion group

Eligibility Criteria

• Age: 3 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants aged 3 to 24 months, diagnosed with microcephaly according to the recommendations of the Surveillance Protocol and response to the occurrence of microcephaly and / or CNS disorders, which considers head circumference less than or equal to 31.5 cm for term boys and 31.9 cm for full term girls. In cases of prematurity, the perimeter will be considered less than 2 or more standard deviations according to the Intergrowth table for gestational age and sex. Mothers should report presence of skin rash or confirmation of Zika virus infection during pregnancy.
• Only children who are accompanied by a neurologist and assisted by physical therapy at least once a week will be included.

You may not qualify if:

• Children who are not taking anticonvulsant and / or antireflux medication when in the presence of seizures and gastroesophageal reflux, respectively;
• Infants who have less than 3 months of botulinum toxin application;
• Infants with osteomioarticular disorders, such as arthrogryposis, or other situations that impede the performance of evaluations and intervention;
• Children who are already active in the aquatic environment (hot tub or hydrotherapy).

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Universidade Federal de Pernambuco

Recife, Pernambuco, 50.740-545, Brazil

Location

MeSH Terms

Conditions

Zika Virus Infection; Microcephaly

Interventions

Hydrotherapy; Immersion

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Officials

• Karla Mônica Ferraz Lambertz

  Universidade Federal de Pernambuco

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: November 6, 2017
• Study Start: June 1, 2017
• Primary Completion: February 18, 2018
• Study Completion: October 30, 2018
• Last Updated: May 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)