Metabolic Bone Disease
Conditions
Keywords
Premature Infant, Physical Therapy Modalities
Brief 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.
Interventions
PROCEDUREReflex Locomotion Therapy
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.
PROCEDUREPassive Joint Mobilizations
Passive Joint Mobilizations with articular pressure described by Moyer-Mileur, et al. 1995 and modified by Vignochi, et al. 2008
PROCEDUREMassage
Soft massage with soft pressures in limbs, tactile stimulation and no motion.
Sponsors
Galaad Torró Ferrero
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Care Provider and Outcomes Assessor are masked to the objectives of the study
Eligibility
Sex/Gender
ALL
Age
No minimum to 34 Weeks
Healthy volunteers
No
Inclusion criteria
* Preterm infants * 26 to 34 weeks of gestational age * Admitted in neonates * Hemodynamically stable * Complete enteral nutrition * Parents or guardians signed an informed consent authorizing the participation of the baby in this study.
Exclusion criteria
* Neurological disorders * Mechanical ventilation * Bronchopulmonary dysplasia * Congenital malformations * Metabolic diseases * Genetic diseases * Intraventricular hemorrhage III-IV, * Diuretic medication or corticosteroids * Bone fractures at the time of inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Urine biomarkers of N-telopeptides from collagen bonds | Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment) | N-telopeptides from collagen bonds |
| Change in Serum biomarkers of Bone-specific phosphatase markers | Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment) | N-telopeptides from collagen bonds from serum |
| Change in Serum biomarkers of osteocalcin markers | Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment) | osteocalcin markers |
| Change in Serum biomarkers of Beta-cross Laps. | Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment) | Beta-cross Laps. |
| Change in Tibial Speed of Sound | Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Weight | Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment) | measurements of weight in grams were collected |
| Change in Head circumference | Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment) | For anthropometry, measurements of head circumference in cm were collected |
| Change in Height | Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment) | For anthropometry, height in cm were collected |
Countries
Spain
Outcome results
None listed