Effects of the Additional Weight on the Reaching Behavior of Pre Term Infants With Low Birth Weight

NCT03405181 | Completed

• 1 other identifier: Additional Weight Trial
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The effects of additional weight on early motor skills of infants have been increasingly studied. During the reaching behavior, the additional weight has been shown benefits in certain kinematic variables in full term and preterm infants. There is a growing interest in the study of populations at risk for motor development, especially considering interventions based on functional activities with the purpose of improving the neuromotor control, functional capacity and muscle strength. The aim of the present study is to investigate the effect of a functional training with additional weight in the reaching behavior of preterm infants with low birth weight and to compare the effects with a full term population. A controlled and randomized trial will be carried out with full term infants of adequate birth weight and preterm infants with low birth weight at 6 months of chronological or corrected age. The participants will be recruited by convenience from the charts of a Public Hospital. Participants will be randomly allocated into four groups: 1) adequate weight placebo group (AWPG); 2) adequate weight intervention group (AWIG); 2) low weight placebo group (LWPG) and 4) low weight intervention group (LWIG). . The assessor will be blinded (no knowledge of groups allocation). All infants will undergo a training program of eight sessions (2x/week; 4 weeks). The AWIG and LWIG will receive the training with an additional weight (characterized by a bracelet with a weight of 20% of the mass of the upper limbs)and the AWPG and LWPG will receive the same training, however, without the additional weight (only the bracelets).. All infants will be assessed in three different moments: 1) Pre-intervention: baseline, before the start of the intervention program; 2) Post-intervention: evaluation performed after the end of the program; and 3) Follow-up: evaluation performed seven days after the post-intervention assessment. The following kinematic dependent variables will be calculated: straightness index, mean velocity and motion units and electromyographic variables: pattern of activation and recruitment of muscle fibers - Biceps brachialis, Triceps brachialis, Deltoid and Pectoralis Major muscles; co-activation between biceps and triceps. The Qualisys Track Manager (QTM) and a wireless surface electromyography with 8-channels will be used. If normality assumptions are met, a mixed 2X2 ANOVA with repeated measures will be applied, in order to verify differences between the intervention programs, considering the dependent variables. Otherwise, non-parametric procedures of the same nature will be adopted. The significance will be set at 5% (P\<0.05).

Conditions

Preterm Infant; Infant Development; Low Birth Weight

Outcome Measures

Primary Outcomes (2)

• Movement unit

  the number of maximum velocities between two minimum velocities, for which the difference was greater than 1 cm/s

  Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)

• Electromyographic activity

  Magnitude of the muscle recruitment during the reaching behavior, measured in microvolts (root mean square - RMS)

  Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)

Secondary Outcomes (6)

• Mean Velocity

  Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)

• Straightness Index

  Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)

• Grasping

  Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)

• Muscle coactivation

  Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)

• Transport Unit

  Change from Pre-Intervention (baseline) compared to Post-Intervention (4 weeks) and Follow-up (7 days)

Study Arms (2)

Training with additional weight

EXPERIMENTAL

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.

Other: Training with additional weight

Training without additional weight

PLACEBO COMPARATOR

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.

Other: Training without additional weight

Interventions

Training with additional weight OTHER

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.

Training with additional weight

Training without additional weight OTHER

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.

Training without additional weight

Eligibility Criteria

• Age: 6 Months - 7 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Brasilia: lead

Study Sites (1)

Campus UnB Ceilandia

Brasília, Federal District, 72220-275, Brazil

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Rodrigo Carregaro, PhD

  University of Brasilia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor won't have any knowledge about the study purposes and will be unaware of the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 19, 2018
• Study Start: January 12, 2018
• Primary Completion: September 15, 2018
• Study Completion: September 15, 2018
• Last Updated: February 25, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)