Effectiveness of Vojta Therapy in Motor Development of Preterm Children

NCT01838278 | Unknown Phase 3 DMC

• 2 other identifiers: Vojta-201303032/PHCS/05
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

\- Justification: Prematurely born children have an increased prevalence of neurodevelopment problems in the first two years. Knowledge regarding the effects of early intervention programs is essential to the follow up of these children and the families.

• Hypothesis: The Vojta Therapy Model showed beneficial effects on motor development outcomes reported by Bayley Sales of Infant Development-Second Edition, in the first 18 months of life on European sample.

Conditions

Movement Disorders

Keywords

Vojta therapy; Exercise Movement Technique; Early intervention

Outcome Measures

Primary Outcomes (1)

• Performance in Psychomotor Subscale - Bayley Scales of Infant and Toddler Development (BSID-II)

  Bayley-II scales, in particular with the Psychomotor Scale. The Bayley Scales of Infant and Toddler Development (BSID-II) are a set of standardized rating scales, which enable us to assess the mental, psychomotor and behavioural development of children between 1 and 42 months

  30 days

Secondary Outcomes (1)

• Performance Cognitive in Subscale of Bayley-II Scales

  30 days

Study Arms (1)

Vojta physiotherapy Method

EXPERIMENTAL

Children in the experimental group or Vojta group, received two weekly sessions of sensory-motor stimulation and two weekly sessions of Vojta physiotherapy. Sensory motor stimulation and Vojta physiotherapy sessions lasted 50 minutes each. A guidance programme was also given to parents to carry out at home to promote the overall development of the child and teach the necessary Vojta method exercises, these were to be performed four times a day for 20 minutes.

Behavioral: Vojta Physiotherapy Method

Interventions

Vojta Physiotherapy Method BEHAVIORAL

Children in the experimental group or Vojta Group, received two weekly sessions of sensory-motor stimulation and two weekly sessions of Vojta Physiotherapy. Sensory motor stimulation and Vojta physiotherapy sessions lasted 50 minutes each. A guidance programme was also given to parents to carry out at home to promote the overall development of the child and teach the necessary Vojta method exercises, these were to be performed four times a day for 20 minutes.

Vojta physiotherapy Method

Eligibility Criteria

• Age: 1 Month - 18 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Experimental Group: First measurement had to be performed during the first trimester of life, from zero to three months corrected age or chronologically depending on the condition of the preterm or full-term infant. Not Diagnosed with any neurological damage and were receiving VT as a method of physiotherapy treatment.
• The A control group: Consisted of premature children with similar base characteristics to the experimental group ones who did not receive VT but another method of physiotherapy treatment within a global programme of early intervention that included sensory-motor stimulation
• The B control group: The control group B was formed by full term infants, without illnesses or risks. Seventy two boys and girls figured in this group. All children were treated and monitored by the Prevention, Promotion of Early Childhood Development and Early Intervention Service at the University of Murcia (Spain).

You may not qualify if:

• Experimental, A and B Groups:Parents don't signed a consent form authorizing the participation of their children in this project

Sponsors & Collaborators

• Universidad de Murcia: lead
• Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia: collaborator

Related Publications (10)

• Spittle AJ, Anderson PJ, Lee KJ, Ferretti C, Eeles A, Orton J, Boyd RN, Inder T, Doyle LW. Preventive care at home for very preterm infants improves infant and caregiver outcomes at 2 years. Pediatrics. 2010 Jul;126(1):e171-8. doi: 10.1542/peds.2009-3137. Epub 2010 Jun 14.

  PMID: 20547650 BACKGROUND

• Kodric J, Sustersic B, Paro-Panjan D. Assessment of general movements and 2.5 year developmental outcomes: pilot results in a diverse preterm group. Eur J Paediatr Neurol. 2010 Mar;14(2):131-7. doi: 10.1016/j.ejpn.2009.04.012. Epub 2009 Jun 21.

  PMID: 19540782 BACKGROUND

• Brandt S, Lonstrup HV, Marner T, Rump KJ, Selmar P, Schack LK, d'Avignon M, Noren L, Arman T. Prevention of cerebral palsy in motor risk infants by treatment ad modum Vojta. A controlled study. Acta Paediatr Scand. 1980 May;69(3):283-6. doi: 10.1111/j.1651-2227.1980.tb07079.x.

  PMID: 7376854 BACKGROUND

• Yigit S, Kerem M, Livanelioglu A, Oran O, Erdem G, Mutlu A, Turanli G, Tekinalp G, Yurdakok M. Early physiotherapy intervention in premature infants. Turk J Pediatr. 2002 Jul-Sep;44(3):224-9.

  PMID: 12405434 BACKGROUND

• Heathcock JC, Lobo M, Galloway JC. Movement training advances the emergence of reaching in infants born at less than 33 weeks of gestational age: a randomized clinical trial. Phys Ther. 2008 Mar;88(3):310-22. doi: 10.2522/ptj.20070145. Epub 2007 Dec 20.

  PMID: 18096650 BACKGROUND

• Cameron EC, Maehle V, Reid J. The effects of an early physical therapy intervention for very preterm, very low birth weight infants: a randomized controlled clinical trial. Pediatr Phys Ther. 2005 Summer;17(2):107-19. doi: 10.1097/01.pep.0000163073.50852.58.

  PMID: 16357661 BACKGROUND

• McGowan JE, Alderdice FA, Holmes VA, Johnston L. Early childhood development of late-preterm infants: a systematic review. Pediatrics. 2011 Jun;127(6):1111-24. doi: 10.1542/peds.2010-2257. Epub 2011 May 29.

  PMID: 21624885 BACKGROUND

• Arnaud C, Daubisse-Marliac L, White-Koning M, Pierrat V, Larroque B, Grandjean H, Alberge C, Marret S, Burguet A, Ancel PY, Supernant K, Kaminski M. Prevalence and associated factors of minor neuromotor dysfunctions at age 5 years in prematurely born children: the EPIPAGE Study. Arch Pediatr Adolesc Med. 2007 Nov;161(11):1053-61. doi: 10.1001/archpedi.161.11.1053.

  PMID: 17984407 RESULT

• Evensen KA, Skranes J, Brubakk AM, Vik T. Predictive value of early motor evaluation in preterm very low birth weight and term small for gestational age children. Early Hum Dev. 2009 Aug;85(8):511-8. doi: 10.1016/j.earlhumdev.2009.04.007. Epub 2009 May 17.

  PMID: 19450939 RESULT

• Petrini JR, Dias T, McCormick MC, Massolo ML, Green NS, Escobar GJ. Increased risk of adverse neurological development for late preterm infants. J Pediatr. 2009 Feb;154(2):169-76. doi: 10.1016/j.jpeds.2008.08.020. Epub 2008 Dec 10.

  PMID: 19081113 RESULT

MeSH Terms

Conditions

Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Julio PL Perez-Lopez, Phd

  Universidad de Murcia

  STUDY DIRECTOR

• Francisco FR J. Fernández-Rego, MD

  Universidad de Murcia

  PRINCIPAL INVESTIGATOR

• María Isabel CG Casbas-Gómez, MD

  Early Intervention Centre "Fina Navarro López" of Lorca City Council. Murcia. Spain

  STUDY CHAIR

• María Teresa MF Martínez-Fuentes, Phd

  Universidad de Murcia

  STUDY CHAIR

• Angela DH Díaz-Herrero, PHd

  Universidad de Murcia

  STUDY CHAIR

• Alfredo BN G. Brito de la Nuez, Phd

  Universidad de Murcia

  STUDY CHAIR

• Tatiana Izabele SR Jaworski de Sa Riechi, PHd

  Federal University of Parana - Brazil

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: profesor catedratico, phd

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: April 24, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: December 1, 2014
• Last Updated: May 7, 2013

Record last verified: 2013-05