- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03330600
Efficacy of Aquatic Physiotherapy in Children With Microcephaly by Zika Virus Congenital Syndrome
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 Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pernambuco
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Recife, Pernambuco, Brazil, 50.740-545
- Universidade Federal de Pernambuco
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: aquatic physicotherapy group
For the experimental group, we will associate kinesiotherapy with immersion in water.
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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 Names:
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 Names:
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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.
|
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 Names:
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in Modified Tardieu Scale
Time Frame: baseline and up 30 minutes
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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.
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baseline and up 30 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in heart rate
Time Frame: baseline and up 30 minutes
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rate of the heart's beat, recorded as the number of beats per minute.
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baseline and up 30 minutes
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change in respiratory frequency
Time Frame: baseline and up 30 minutes
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The number of breaths per minute.
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baseline and up 30 minutes
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change in oxygen saturation
Time Frame: baseline and up 30 minutes
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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%.
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baseline and up 30 minutes
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change in body temperature
Time Frame: baseline and up 30 minutes
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the degree of sensible heat or cold, expressed in terms of Celsius
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baseline and up 30 minutes
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Collaborators and Investigators
Investigators
- Study Chair: Karla Mônica Ferraz Lambertz, Universidade Federal de Pernambuco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Congenital Abnormalities
- Musculoskeletal Diseases
- Arbovirus Infections
- Vector Borne Diseases
- Flavivirus Infections
- Flaviviridae Infections
- Craniofacial Abnormalities
- Musculoskeletal Abnormalities
- Malformations of Cortical Development, Group I
- Malformations of Cortical Development
- Nervous System Malformations
- Microcephaly
- Zika Virus Infection
Other Study ID Numbers
- Projeto Milena LEPed
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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