search
Back to results

Effectiveness of Vojta Therapy in Motor Development of Preterm Children

Primary Purpose

Movement Disorders

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Vojta Physiotherapy Method
Sponsored by
Universidad de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Movement Disorders focused on measuring Vojta therapy, Exercise Movement Technique, Early intervention

Eligibility Criteria

1 Month - 18 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Vojta physiotherapy Method

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Performance Cognitive in Subscale of Bayley-II Scales
    Bayley-II scales, in particular with the Cognition 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

    Full Information

    First Posted
    April 18, 2013
    Last Updated
    May 6, 2013
    Sponsor
    Universidad de Murcia
    Collaborators
    Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01838278
    Brief Title
    Effectiveness of Vojta Therapy in Motor Development of Preterm Children
    Official Title
    Effectiveness of Vojta Therapy in Motor Development of Preterm Children
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    March 2013 (Actual)
    Study Completion Date
    December 2014 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad de Murcia
    Collaborators
    Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Premature children constitute a heterogeneous group regarding gestational age, determinants and causes of their premature birth, illnesses that occur during the neonatal period and the socio-economic status of the family. These constraints could cause an increase in the risk of development in this group of children, as well as motor abnormalities, when compared to the population of infants born at full term. Cerebral Palsy (CP), for example, is the most common neurological disorder in this group of children. So many studies showed the association between CP and prematurity. They have pointed out that the probability of premature infants having CP is eight times higher compared to full-term infants. Apart from CP other minor motor abnormalities are also present in the range of consequences for the preterm children. Therefore, if the increase is considered in children born prematurely who survive, on account of developments in neonatal care, and that the frequency of appearance of motor sequel described in them remains constant, it is of crucial importance from social, economic and health aspects to implement strategies to improve outcomes for these children. In this regard, the development of physiotherapy treatments aimed at preterm infants is essential from a prevention and intervention point of view. At the Region of Murcia/Spain, when one child is born preterm is directed from the Neonatal Intensive Care Unit (NICU), where there has already been established a protocol for immediate referral among hospitals to early intervention services, where an interdisciplinary team develops an individualized and comprehensive intervention plan according to the characteristics and conditions of each child and, from the motor point of view, the physiotherapist team will be the one who determines the most appropriate action to be taken. According Vojta, the basic motor function of human has developed in the course of the first year of life, in a process named Postural and Motor Ontogenesis. The practice of Vojta Therapy (VT) had proved to be effective at the treatment of neuromuscular disturbs. Finally, another researches emphasize the importance of follow up of premature children, due to some problems capable of causing motor disability that might not be detectable in the first moments of life, therefore a longitudinal follow-up is recommended. Regarding this matter, the general aim of this study is to compare the efficiency of the VT on children motor development opposed to other physiotherapy intervention methods used with premature infants without neurological damage, throughout the first 18 months of life, and taking a group of full term infants as a reference. In order to do so, using a longitudinal research design, referring to four different age-groups where children were followed from the first trimester of life until 18 months, corrected age for premature infants and chronologically for full term infants. - METHODS: This is a longitudinal research design with four assessment follow up during the first trimester (1), at 6, 12 and 18 months. The children are divided into three groups. An experimental group with premature children treated with Vojta Therapy a control group with premature children treated with other traditional physiotherapy methods and another control group (Group 3) with full term infants presenting no risk or pathology. Instrument: In order to measure motor development, all children in the experimental group and control groups A and B are evaluated with the 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 behavioral development of children between 1 and 42 months Samples: The experimental group is composed by preterm children (<37 weeks gestational age), that presented psychomotor delay, but who were not diagnosed with any neurological damage and were receiving VT as a method of physiotherapy treatment, as well as a programme of early intervention including sensory-motor stimulation. This group consists the boys and girls treated at the Early Intervention Centre of Lorca and Aguilas/ Murcia, Spain. The control group A consists 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. These children are treated and monitored by the Early Intervention Service from the Board of Education of the Region of Murcia (Spain). The control group B is 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). All parents must sign a consent form authorizing the participation of their children in this project. - Interventions: Children in the experimental group or Vojta group, receive two weekly sessions of sensory-motor stimulation and two weekly sessions of Vojta Physiotherapy. Sensory motor stimulation and Vojta physiotherapy sessions last 50 minutes each. A guidance programme is 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 are to be performed four times a day for 20 minutes. Children in control group A or Non-Vojta group, receive two weekly sessions of sensory-motor stimulation and two weekly sessions of physiotherapy with a different methodology to Vojta. Duration of sessions is the same as in the experimental group, of 50 minutes. A guidance programme is also given to parents to carry out at home to promote the overall development of the child and recommendations are provided regarding postural and motor skills that every child needed to ensure proper handling at home. Children in control group B or the full term infant group receive no intervention of any type but parents are given pointers to promote development at home. Interventions regarding sensory-motor stimulation in the Early Intervention Centre and guidelines for full term children are carried out by psychologists and specialists in Early Intervention. Vojta Physiotherapy interventions are performed by expert physiotherapists trained in the method by Vojta Association International. ANALYSIS OF THE RESULTS All data are analyzed using the computerized statistical package SPSS 15.0 for Windows. In order to verify our objective, the efficiency of the Vojta Method in motor development of preterm children in the first 18 months of life compared to other physiotherapy methods and using a full term infant group as a reference, mixed 2-factor ANOVA (3x4) with an inter-subject factor (type of sample) with three levels (Vojta, Non-Vojta and Full Term) and one intra-subject factor of repeated assessment (motor development) with 4 measurement times (first trimester, 6, 12 and 18 months) will be used.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Movement Disorders
    Keywords
    Vojta therapy, Exercise Movement Technique, Early intervention

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    120 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Vojta physiotherapy Method
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Vojta Physiotherapy Method
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Performance in Psychomotor Subscale - Bayley Scales of Infant and Toddler Development (BSID-II)
    Description
    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
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    Performance Cognitive in Subscale of Bayley-II Scales
    Description
    Bayley-II scales, in particular with the Cognition 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
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Month
    Maximum Age & Unit of Time
    18 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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). Exclusion Criteria: Experimental, A and B Groups:Parents don't signed a consent form authorizing the participation of their children in this project
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Julio PL Perez-Lopez, Phd
    Organizational Affiliation
    Universidad de Murcia
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Francisco FR J. Fernández-Rego, MD
    Organizational Affiliation
    Universidad de Murcia
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    María Isabel CG Casbas-Gómez, MD
    Organizational Affiliation
    Early Intervention Centre "Fina Navarro López" of Lorca City Council. Murcia. Spain
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    María Teresa MF Martínez-Fuentes, Phd
    Organizational Affiliation
    Universidad de Murcia
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Angela DH Díaz-Herrero, PHd
    Organizational Affiliation
    Universidad de Murcia
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Alfredo BN G. Brito de la Nuez, Phd
    Organizational Affiliation
    Universidad de Murcia
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Tatiana Izabele SR Jaworski de Sa Riechi, PHd
    Organizational Affiliation
    Federal University of Parana - Brazil
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20547650
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    19540782
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    7376854
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    12405434
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    18096650
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16357661
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21624885
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    17984407
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    19450939
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    19081113
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

    Effectiveness of Vojta Therapy in Motor Development of Preterm Children

    We'll reach out to this number within 24 hrs