Effects of the Additional Weight on the Reaching Behavior of Pre Term Infants With Low Birth Weight
Effects of the Additional Weight on the Reaching Behavior of Preterm Infants With Low Birth Weight: Randomized Controlled Trial
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Tipo de estudio
Tipo de estudio
Inscripción (Actual)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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DF
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Brasília, DF, Brasil, 72220-275
- Campus UnB Ceilandia
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adequate weight infants: healthy infants born with gestational age between 38-42 weeks and adequate birth weight (> 2500 grams);
- Low weight infants: healthy infants born with gestational age between 32-36 weeks and 6 days and with low birth weight (between 1500 and 2500 grams).
Exclusion Criteria:
- Anoxiated infants;
- Signs of neurological impairment (eg, hypoxic-ischemic encephalopathies grade I, II and III, intracranial hemorrhage and neonatal seizures);
- Congenital malformations (eg myelomeningocele and achondroplasias);
- Syndromes (e.g Down Syndrome);
- Sensorial alterations (visual and auditory);
- Cardiorespiratory difficulties;
- Orthopedic impairments (e.g, congenital clubfoot);
- Apgar below 8 and 10 in the first and fifth minutes, respectively.
- Infants who do not attend any of the evaluations, who do not complete at least 80% of the training or who cry uncontrollably, not allowing at least 10 reachings in the evaluations and training. Those that present intercurrences that may compromise normal neurosensorimotor development (for example, recurrent pneumonia, kidney and intestinal infection).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
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Experimental: Training with additional weight
The infants will be submitted to a reaching behavior training program of 4 weeks, two times per week (totaling 8 sessions).
During this training program, infants will use a bracelet with an additional weight characterized by 20% of the total mass of the upper limb placed on both wrists.
This training will be adopted for the adequate weight intervention group and low weight intervention group.
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The infants will be positioned in a reclined position.
A bracelet with an additional weight (20% of the total mass of the upper limb) will be placed on both wrists.
The training will happen 2x/week, during 4 weeks (8 sessions).
An object will be used to stimulate the reaching behavior, which will be displayed by the examiner (positioned in front of the infant), and presented in the midline at shoulder height, considering the distance from the arm's length of the infant to the height of the wrist.
The physiotherapist will draw the attention of the infant to the object, moving it momentarily so that the infant perceives it and reaches it.
After reaching, the object will be carefully removed and resubmitted in order to elicit a new movement.
The interval between each presentation will be of approximately 5 seconds.
At least 10 movements will be stimulated.
If the infant does not achieve the 10 reaches within the maximum interval of 15 minutes, the session will be terminated.
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Comparador de placebos: Training without additional weight
The infants will be submitted to a reaching behavior training program of 4 weeks, two times per week (totaling 8 sessions).
During this training program, infants will use a bracelet without additional weight, placed on both wrists.
This training will be adopted for the adequate weight placebo group and low weight placebo group.
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The infants will be positioned in a reclined position.
A bracelet without the additional weight will be placed on both wrists.
The training will happen 2x/week, during 4 weeks (8 sessions).
An object will be used to stimulate the reaching behavior, which will be displayed by the examiner (positioned in front of the infant), and presented in the midline at shoulder height, considering the distance from the arm's length of the infant to the height of the wrist.
The physiotherapist will draw the attention of the infant to the object, moving it momentarily so that the infant perceives it and reaches the object.
After reaching, the object will be carefully removed (or picked up) and resubmitted in order to elicit a new movement.
The interval between each presentation of the object will be of approximately 5 seconds.
At least 10 movements will be stimulated.
If the infant does not achieve the 10 reaches within the maximum interval of 15 minutes, the session will be terminated.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Movement unit
Periodo de tiempo: Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
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the number of maximum velocities between two minimum velocities, for which the difference was greater than 1 cm/s
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Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
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Electromyographic activity
Periodo de tiempo: Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
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Magnitude of the muscle recruitment during the reaching behavior, measured in microvolts (root mean square - RMS)
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Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mean Velocity
Periodo de tiempo: Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
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the ratio between the distance traveled during the reaching behavior and the duration of the movement
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Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
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Straightness Index
Periodo de tiempo: Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
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ratio between the minimal distance that could have been traveled in this trajectory (distance between the initial position of the hand and the object) and the distance traveled by the hand (total trajectory).
The closer is this index to 1, the straighter is the trajectory.
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Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
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Grasping
Periodo de tiempo: Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
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categorical variable classified into (a) successful: when the infant was able to grasp the object with one or both hands; and (b) unsuccessful: when the infant touched the object, but did not grasp it
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Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
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Muscle coactivation
Periodo de tiempo: Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
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Coactivation between the biceps and triceps muscle during the reaching behavior, measured in percentage (activation of the biceps/activation of the triceps)
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Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
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Transport Unit
Periodo de tiempo: Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
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The relative duration of the first movement unit in relation to total duration of reaching
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Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
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Deceleration time
Periodo de tiempo: Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
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The time necessary for the infant to decelerate the arm movement so that the hand touches an object.
This period of the duration is measured from the time of appearance of the peak of velocity to the end of the reach.
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Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)
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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Director de estudio: Rodrigo Carregaro, PhD, University of Brasilia
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Inicio del estudio
Finalización primaria (Actual)
Finalización primaria
Finalización del estudio (Actual)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- Additional Weight Trial
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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