Physical Therapy to Prevent Osteopenia in Preterm Infants

Not Applicable

Completed

• Conditions: Metabolic Bone Disease
• Interventions: Procedure: Reflex Locomotion Therapy; Procedure: Passive Joint Mobilizations; Procedure: Massage

• Registration Number: NCT04356807
• Lead Sponsor: Galaad Torró Ferrero

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-04-19
• Study First Posted: 2020-04-22
• Primary Completion: 2020-07
• Study Completion: 2020-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reflex Locomotion Therapy	Reflex Locomotion Therapy	during 15 minutes once a day five days a week
Passive Joint Mobilizations	Passive Joint Mobilizations	during 15 minutes once a day five days a week
Massage	Massage	during 15 minutes once a day five days a week

Primary Outcome Measures

Name	Time	Method
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.
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 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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (3)

Hospital Clínico Universitario Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Hospital Torrecárdenas de Almería; 🇪🇸 Almería, Spain

Hospital General Universitario de Elche; 🇪🇸 Elche, Alicante, Spain