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Metabolic Bone DiseaseNCT04356807

Physical Therapy to Prevent Osteopenia in Preterm Infants

A study testing Reflex Locomotion Therapy, Passive Joint Mobilizations and Massage in people with Metabolic Bone Disease, run by Galaad Torró Ferrero at 3 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages Up to 34 weeks
Conditions the study is for
Metabolic Bone Disease
What is being tested?
Reflex Locomotion Therapy, Passive Joint Mobilizations and Massage
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
101 participants
Where
3 sitesSpain
Study dates
Feb 2016to Jul 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 34 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • Neurological disorders
  • Mechanical ventilation
  • Bronchopulmonary dysplasia
  • Congenital malformations
  • Metabolic diseases
  • Genetic diseases
Show all 9Show fewer
  • Intraventricular hemorrhage III-IV,
  • Diuretic medication or corticosteroids
  • Bone fractures at the time of inclusion.

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

  • Hospital Torrecárdenas de Almería

    Almería, 04009

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, 30120

Other trials in Spain

About this study

Official title: 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

Read the 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.

Being tested
Reflex Locomotion Therapy, Passive Joint Mobilizations, Massage
Keywords
Premature Infant, Physical Therapy Modalities
Medical subject headings
Bone Diseases, Metabolic, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reflex Locomotion TherapyProcedure or surgery

    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 MobilizationsProcedure or surgery

    Passive Joint Mobilizations with articular pressure described by Moyer-Mileur, et al. 1995 and modified by Vignochi, et al. 2008

  • MassageProcedure or surgery

    Soft massage with soft pressures in limbs, tactile stimulation and no motion.

Study groups in NCT04356807
Study groupRoleWhat they receive
Reflex Locomotion TherapyExperimentalduring 15 minutes once a day five days a week
Receives: Procedure: Reflex Locomotion Therapy
Passive Joint MobilizationsExperimentalduring 15 minutes once a day five days a week
Receives: Procedure: Passive Joint Mobilizations
MassagePlacebo comparatorduring 15 minutes once a day five days a week
Receives: Procedure: Massage

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)

  2. Change in Serum biomarkers of Bone-specific phosphatase markers

    N-telopeptides from collagen bonds from serum

    Measured: Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)

  3. Change in Serum biomarkers of osteocalcin markers

    osteocalcin markers

    Measured: Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)

  4. Change in Serum biomarkers of Beta-cross Laps.

    Beta-cross Laps.

    Measured: Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment)

  5. Change in Urine biomarkers of N-telopeptides from collagen bonds

    N-telopeptides from collagen bonds

    Measured: Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)

Secondary outcomes (3)

  1. Change in Height

    For anthropometry, height in cm were collected

    Measured: Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)

  2. Change in Weight

    measurements of weight in grams were collected

    Measured: Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)

  3. Change in Head circumference

    For anthropometry, measurements of head circumference in cm were collected

    Measured: Change measurement: Pre treatment (baseline), at two weeks of treatment and after four weeks of treatment (end of the treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2020
  2. Study startFeb 2016
  3. Primary completionJul 2020
  4. Study completionJul 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04356807
Sponsor's protocol ID
Fisio-Osteopenia
Status last verified
Apr 2025
First submitted
17 Mar 2020
Last updated
25 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared after contacting the authors

Publications

  • Vignochi CM, Miura E, Canani LH. Effects of motor physical therapy on bone mineralization in premature infants: a randomized controlled study. J Perinatol. 2008 Sep;28(9):624-31. doi: 10.1038/jp.2008.60. Epub 2008 Jul 17.

    PubMed 18633420

  • Vignochi CM, Silveira RC, Miura E, Canani LH, Procianoy RS. Physical therapy reduces bone resorption and increases bone formation in preterm infants. Am J Perinatol. 2012 Sep;29(8):573-8. doi: 10.1055/s-0032-1310520. Epub 2012 Jul 6.

    PubMed 22773291

  • Moyer-Mileur L, Luetkemeier M, Boomer L, Chan GM. Effect of physical activity on bone mineralization in premature infants. J Pediatr. 1995 Oct;127(4):620-5. doi: 10.1016/s0022-3476(95)70127-3.

    PubMed 7562289

  • Shaw SC, Sankar MJ, Thukral A, Natarajan CK, Deorari AK, Paul VK, Agarwal R. Assisted Physical Exercise for Improving Bone Strength in Preterm Infants Less than 35 Weeks Gestation: A Randomized Controlled Trial. Indian Pediatr. 2018 Feb 15;55(2):115-120. Epub 2017 Dec 14.

    PubMed 29242413

  • Giannantonio C, Papacci P, Ciarniello R, Tesfagabir MG, Purcaro V, Cota F, Semeraro CM, Romagnoli C. Chest physiotherapy in preterm infants with lung diseases. Ital J Pediatr. 2010 Sep 26;36:65. doi: 10.1186/1824-7288-36-65.

    PubMed 20868518

  • El-shaarawy MK, Rahman SAA, Fakher M, El A, Salah WM. Effect of rolling on oxygen saturation and incubation period in preterm neonates with respiratory distress syndrome. Int J Dev Res. 2017;07(01):11319-11323.

  • Sanz-Esteban I, Calvo-Lobo C, Rios-Lago M, Alvarez-Linera J, Munoz-Garcia D, Rodriguez-Sanz D. Mapping the human brain during a specific Vojta's tactile input: the ipsilateral putamen's role. Medicine (Baltimore). 2018 Mar;97(13):e0253. doi: 10.1097/MD.0000000000010253.

    PubMed 29595683

  • Torro-Ferrero G, Fernandez-Rego FJ, Aguera-Arenas JJ, Gomez-Conesa A. Effect of physiotherapy on the promotion of bone mineralization in preterm infants: a randomized controlled trial. Sci Rep. 2022 Jul 8;12(1):11680. doi: 10.1038/s41598-022-15810-6.

    PubMed 35804078

  • Torro-Ferrero G, Fernandez-Rego FJ, Jimenez-Liria MR, Aguera-Arenas JJ, Pinero-Penalver J, Sanchez-Joya MDM, Fernandez-Berenguer MJ, Rodriguez-Perez M, Gomez-Conesa A. Effect of physical therapy on bone remodelling in preterm infants: a multicenter randomized controlled clinical trial. BMC Pediatr. 2022 Jun 24;22(1):362. doi: 10.1186/s12887-022-03402-2.

    PubMed 35739544

Questions about this trial

What is this clinical trial studying?

A study testing Reflex Locomotion Therapy, Passive Joint Mobilizations and Massage in people with Metabolic Bone Disease, run by Galaad Torró Ferrero at 3 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04356807, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.

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