Physical Therapy to Prevent Osteopenia in Preterm Infants

November 27, 2020 updated by: Galaad Torró Ferrero

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almería, Spain, 04009
        • Hospital Torrecárdenas de Almería
      • Murcia, Spain, 30120
        • Hospital Clínico Universitario Virgen de la Arrixaca
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reflex Locomotion Therapy
during 15 minutes once a day five days a week
Procedure: Reflex 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.
Experimental: Passive Joint Mobilizations
during 15 minutes once a day five days a week
Procedure: Passive Joint Mobilizations
Passive Joint Mobilizations with articular pressure described by Moyer-Mileur, et al. 1995 and modified by Vignochi, et al. 2008
Placebo Comparator: Massage
during 15 minutes once a day five days a week
Procedure: Massage
Soft massage with soft pressures in limbs, tactile stimulation and no motion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Tibial Speed of Sound
Time Frame: 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 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
Time Frame: Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)
N-telopeptides from collagen bonds from serum
Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)
Change in Serum biomarkers of osteocalcin markers
Time Frame: Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)
osteocalcin markers
Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)
Change in Serum biomarkers of Beta-cross Laps.
Time Frame: Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)
Beta-cross Laps.
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
Time Frame: 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 measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Height
Time Frame: 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 measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)
Change in Weight
Time Frame: 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 measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)
Change in Head circumference
Time Frame: 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 measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galaad Torró Ferrero

Investigators

  • Principal Investigator: Galaad Torró-Ferrero, MSc, Universidad de Murcia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2016

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

March 17, 2020

First Submitted That Met QC Criteria

April 19, 2020

First Posted (Actual)

April 22, 2020

Study Record Updates

Last Update Posted (Actual)

December 1, 2020

Last Update Submitted That Met QC Criteria

November 27, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fisio-Osteopenia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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