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

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ClinicalTrials.gov Identifier: NCT03330600
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Milena Guimarães Monteiro, Universidade Federal de Pernambuco

Tracking Information
First Submitted Date  ICMJE October 16, 2017
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date May 7, 2019
Actual Study Start Date  ICMJE June 1, 2017
Actual Primary Completion Date February 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
change in Modified Tardieu Scale [ Time Frame: baseline and up 30 minutes ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
  • change in heart rate [ Time Frame: baseline and up 30 minutes ]
    rate of the heart's beat, recorded as the number of beats per minute.
  • change in respiratory frequency [ Time Frame: baseline and up 30 minutes ]
    The number of breaths per minute.
  • change in oxygen saturation [ Time Frame: baseline and up 30 minutes ]
    the fraction of the hemoglobin molecules in a blood sample that are saturated with oxygen at a given partial pressure of oxygen. Normal saturation is 95% to 100%.
  • change in body temperature [ Time Frame: baseline and up 30 minutes ]
    the degree of sensible heat or cold, expressed in terms of Celsius
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Aquatic Physiotherapy in Children With Microcephaly by Zika Virus Congenital Syndrome
Official Title  ICMJE Efficacy of Aquatic Physiotherapy in Stress Level and Muscle Tone of Children Between 3 and 24 Months With Microcephaly by Zika Virus Congenital Syndrome
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.
Detailed Description

A randomized, controlled, blind crossover study will be conducted at the Laboratory of Pediatric Studies (LEPED) located in the Physiotherapy Department of the Federal University of Pernambuco (UFPE), from January 2017 to November 2017. The study will be composed infants diagnosed with microcephaly associated with Zika virus Syndrome of the state of Pernambuco (PE), recruited for convenience of both sexes, aged 3 to 24 months of life.

Initially randomization of these children will be performed through randomization.com. and allocation in two groups (experimental and control) for the first session. After a period of one week (washout period), the groups are reversed so that everyone receives both interventions. Children in the experimental group will be submitted to a session of aquatic physiotherapy and the group control the immersion in water, described later. The study will be composed of two main researchers, the researcher 1 responsible for the intervention and the researcher 2 responsible for the evaluations, who will be blind to the intervention.

The collection of the clinical and sociodemographic data of the responsible person and the child will be done through the evaluation form developed for the research. Before the intervention, the child and the caregiver will be accommodated in a room with temperature, luminosity and controlled noises so that they can rest and thus minimize the effects of the route to the place of data collection. The evaluation begins with the assessment of muscle tone of the upper limbs and lower limbs, physiological parameters, postaral evaluation and application of questionnaires about maternal perception about the behavior of the and the level of stress. Immediately after the intervention will be reassessed muscle tone, physiological parameters and applied a questionnaire of maternal satisfaction about the therapy applied and perception of stress level.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Zika Virus Infection
  • Microcephaly
Intervention  ICMJE
  • Behavioral: aquatic physicotherapy
    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.
    Other Name: hydrotherapy
  • Behavioral: immersion
    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.
    Other Name: hydrotherapy
Study Arms  ICMJE
  • Experimental: aquatic physicotherapy group
    For the experimental group, we will associate kinesiotherapy with immersion in water.
    Interventions:
    • Behavioral: aquatic physicotherapy
    • Behavioral: immersion
  • Placebo Comparator: immersion group
    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.
    Interventions:
    • Behavioral: aquatic physicotherapy
    • Behavioral: immersion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2019)
12
Original Estimated Enrollment  ICMJE
 (submitted: October 30, 2017)
20
Actual Study Completion Date  ICMJE October 30, 2018
Actual Primary Completion Date February 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Months to 24 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03330600
Other Study ID Numbers  ICMJE Projeto Milena LEPed
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Milena Guimarães Monteiro, Universidade Federal de Pernambuco
Study Sponsor  ICMJE Universidade Federal de Pernambuco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Karla Mônica Ferraz Lambertz Universidade Federal de Pernambuco
PRS Account Universidade Federal de Pernambuco
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP