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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
101
The 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.
Passive Joint Mobilizations with articular pressure described by Moyer-Mileur, et al. 1995 and modified by Vignochi, et al. 2008
Soft massage with soft pressures in limbs, tactile stimulation and no motion.
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital Torrecárdenas de Almería
Almería, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain
Change in Tibial Speed of Sound
In order to measure bone mineralization, we used the tibial sound velocity test, using for that purpose a quantitative ultrasound device. It was measured on the left tibia in its lower third, while keeping the knee flexed at a 90 degree angle. The measurement point was made perpendicular to the direction of the bone. Three to five consecutive measurements were made, after which the average of these measurements was calculated to have one unique measure in m/s.
Time frame: Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)
Change in Serum biomarkers of Bone-specific phosphatase markers
N-telopeptides from collagen bonds from serum
Time frame: Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)
Change in Serum biomarkers of osteocalcin markers
osteocalcin markers
Time frame: Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)
Change in Serum biomarkers of Beta-cross Laps.
Beta-cross Laps.
Time frame: Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)
Change in Urine biomarkers of N-telopeptides from collagen bonds
N-telopeptides from collagen bonds
Time frame: Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)
Change in Height
For anthropometry, height in cm were collected
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Time frame: Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)
Change in Weight
measurements of weight in grams were collected
Time frame: Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)
Change in Head circumference
For anthropometry, measurements of head circumference in cm were collected
Time frame: Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)