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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reflex Locomotion Therapy | Experimental | during 15 minutes once a day five days a week |
|
| Passive Joint Mobilizations | Experimental | during 15 minutes once a day five days a week |
|
| Massage | Placebo Comparator | during 15 minutes once a day five days a week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reflex Locomotion Therapy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | Change measurement: Pre treatment (baseline), and after four weeks of treatment (end of the treatment) |
| Change in Serum biomarkers of osteocalcin markers | 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. | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Height | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Neurological disorders
Mechanical ventilation
Congenital malformations
Metabolic diseases
Genetic diseases
Intraventricular hemorrhage III-IV,
Diuretic medication or corticosteroids
Bone fractures at the time of inclusion.
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| Name | Affiliation | Role |
|---|---|---|
| Galaad Torró-Ferrero, MSc | Universidad de Murcia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario de Elche | Elche | Alicante | 03203 | Spain | ||
| Hospital Torrecárdenas de Almería |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18633420 | Background | 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. | |
| 22773291 | Background | 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. |
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Data will be shared after contacting the authors
indefinitive
Data will be shared after contacting the authors under reasonable request
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2015 | Jul 2, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008405 | Massage |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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Care Provider and Outcomes Assessor are masked to the objectives of the study
| Passive Joint Mobilizations | Procedure | Passive Joint Mobilizations with articular pressure described by Moyer-Mileur, et al. 1995 and modified by Vignochi, et al. 2008 |
|
| Massage | Procedure | Soft massage with soft pressures in limbs, tactile stimulation and no motion. |
|
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 | 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) |
| Almería |
| 04009 |
| Spain |
| Hospital Clínico Universitario Virgen de la Arrixaca | Murcia | 30120 | Spain |
| 7562289 | Background | 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. |
| 29242413 | Background | 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. |
| 20868518 | Background | 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. |
| Background | 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. |
| 29595683 | Background | 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. |
| 35804078 | Derived | 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. |
| 35739544 | Derived | 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. |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |