Efficacy of Aquatic Physiotherapy in Children With Microcephaly by Zika Virus Congenital Syndrome
Primary Purpose
Zika Virus Infection, Microcephaly
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
aquatic physicotherapy
immersion
Sponsored by
About this trial
This is an interventional treatment trial for Zika Virus Infection
Eligibility Criteria
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).
Sites / Locations
- Universidade Federal de Pernambuco
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
aquatic physicotherapy group
immersion group
Arm Description
For the experimental group, we will associate kinesiotherapy with immersion in water.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
change in heart rate
rate of the heart's beat, recorded as the number of beats per minute.
change in respiratory frequency
The number of breaths per minute.
change in oxygen saturation
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
the degree of sensible heat or cold, expressed in terms of Celsius
Full Information
NCT ID
NCT03330600
First Posted
October 16, 2017
Last Updated
May 3, 2019
Sponsor
Universidade Federal de Pernambuco
1. Study Identification
Unique Protocol Identification Number
NCT03330600
Brief Title
Efficacy of Aquatic Physiotherapy in Children With Microcephaly by Zika Virus Congenital Syndrome
Official Title
Efficacy of Aquatic Physiotherapy in Stress Level and Muscle Tone of Children Between 3 and 24 Months With Microcephaly by Zika Virus Congenital Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
February 18, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zika Virus Infection, Microcephaly
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aquatic physicotherapy group
Arm Type
Experimental
Arm Description
For the experimental group, we will associate kinesiotherapy with immersion in water.
Arm Title
immersion group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
aquatic physicotherapy
Other Intervention Name(s)
hydrotherapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
immersion
Other Intervention Name(s)
hydrotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in Modified Tardieu Scale
Description
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.
Time Frame
baseline and up 30 minutes
Secondary Outcome Measure Information:
Title
change in heart rate
Description
rate of the heart's beat, recorded as the number of beats per minute.
Time Frame
baseline and up 30 minutes
Title
change in respiratory frequency
Description
The number of breaths per minute.
Time Frame
baseline and up 30 minutes
Title
change in oxygen saturation
Description
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%.
Time Frame
baseline and up 30 minutes
Title
change in body temperature
Description
the degree of sensible heat or cold, expressed in terms of Celsius
Time Frame
baseline and up 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karla Mônica Ferraz Lambertz
Organizational Affiliation
Universidade Federal de Pernambuco
Official's Role
Study Chair
Facility Information:
Facility Name
Universidade Federal de Pernambuco
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50.740-545
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of Aquatic Physiotherapy in Children With Microcephaly by Zika Virus Congenital Syndrome
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