Clinical Trials Directory

Trials / Completed

CompletedNCT04356807

Physical Therapy to Prevent Osteopenia in Preterm Infants

Effect of Physiotherapy on the Promotion of Bone Mineralization in Preterm Infants

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
101 (actual)
Sponsor
Galaad Torró Ferrero · Academic / Other
Sex
All
Age
34 Weeks
Healthy volunteers
Not accepted

Summary

To determine whether reflex locomotion therapy is effective for the prevention of osteopenia in preterm infants and compare its effectiveness over other physiotherapeutic methods like passive joint mobilizations and massage

Detailed description

Premature infants have smaller and low bone mineralization compared with term infants bones, since 80% of calcium uptake occurs at the end of pregnancy. Passive Physiotherapy has been effective in the treatment of osteopenia. Active mobilizations implemented by the baby itself, may be more effective than passive, as they cause muscle contraction from the Central Nervous System (CNS). Reflex locomotion therapy (RLT), stimulates CNS causing muscle contraction so it may be effective in the treatment of osteopenia in premature. Objectives: To determine whether RLT is effective for the prevention of osteopenia in preterm infants and compare its effectiveness over other physiotherapeutic methods. Methodology: Our study is a multicentre randomized clinical trial, with 90 children less than 34 weeks of gestational age, divided into three treatment groups, one will receive RLT, another will be treated with passive joint mobilizations with articular pressure; and last one will be done massage techniques. The treatment will last for one month, for the three groups. We intend to measure changes in mineralization, bone formation, and bone resorption, and anthropometry.

Conditions

Interventions

TypeNameDescription
PROCEDUREReflex Locomotion TherapyThe exercises corresponding to the motor complexes of the 1st phase of the rolling reflex and the original creeping reflex were performed, dedicating one minute to each side and performing two repetitions in each session.
PROCEDUREPassive Joint MobilizationsPassive Joint Mobilizations with articular pressure described by Moyer-Mileur, et al. 1995 and modified by Vignochi, et al. 2008
PROCEDUREMassageSoft massage with soft pressures in limbs, tactile stimulation and no motion.

Timeline

Start date
2016-02-01
Primary completion
2020-07-01
Completion
2020-07-01
First posted
2020-04-22
Last updated
2025-04-25

Locations

3 sites across 1 country: Spain

Source: ClinicalTrials.gov record NCT04356807. Inclusion in this directory is not an endorsement.