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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: German Clinical Trials Register
Last refreshed on: 5 December 2018
Main ID:  DRKS00014775
Date of registration: 25/05/2018
Prospective Registration: No
Primary sponsor: Faculty of Medicine, University of Murcia, Spain. V. de la Arrixaca University Hospital, Department of Traumatology, Murcia, Spain.
Public title: Effect of Vojta or Reflex locomotion therapy on the gross motor function of children with cerebral palsy
Scientific title: Effect of Vojta or Reflex locomotion therapy on the gross motor function of children with cerebral palsy - VTCP
Date of first enrolment: 04/05/2018
Target sample size: 30
Recruitment status: Recruiting
URL:  http://www.drks.de/DRKS00014775
Study type:  interventional
Study design:  Allocation: Single arm study;. Masking: Open (masking not used). Control: Uncontrolled/Single arm. Assignment: Single (group). Study design purpose: Treatment;  
Phase:  N/A
Countries of recruitment
Germany Spain United Kingdom
Contacts
Name: Jose Manuel    Sanz-Mengibar
Address:  7 Newberry Mews SW4 7EL London United Kingdom
Telephone: +447726764081
Email: jmsmengibar@hotmail.com
Affiliation:  University of Murcia
Name: Jose Manuel    Sanz-Mengibar
Address:  7 Newberry Mews SW4 7EL London United Kingdom
Telephone: +447726764081
Email: josemanuel.sanz@um.es
Affiliation:  University of Murcia
Key inclusion & exclusion criteria
Inclusion criteria: Male and female between zero and 18 months of age with neurological findings consistent with neuromotor disorders were recruited when the family inquired Reflex Locomotion therapy in different physiotherapy clinics in Spain, Germany and London (United Kingdom). The diagnosis of cerebral palsy can not be always confirmed within such an early stage, and neuromuscular disorders or other conditions that could affect motor performance need to be ruled out; therefore, the data of the children were included retrospectively on a later stage when the diagnosis was confirmed. In addition, participants’ parents or guardians gave informed consent. The previous therapeutic trajectory was not considered within the exclusion criteria for two reasons: their effect would be already included within the speed of motor development before RL, and also because all the children were controlled with themselves.
Exclusion criteria: Data of the children are excluded if they introduced another therapy input or they dropped any of the previous ones during the two months of RL intervention (pharmacological, surgical or rehabilitative). For ethical reasons, this was not specified to the families who agreed to join the trial, in order not to influence their future therapeutic decisions.

Age minimum: 1 Months
Age maximum: 18 Months
Gender: Both, male and female
Health Condition(s) or Problem(s) studied
G80 - Cerebral palsy
Intervention(s)
Intervention 1: RL therapy will be carried out once a week for 2 months, by a trained physiotherapist. This therapist will also train the parents in the exercises to establish a daily home program (between one and four times per day). Therapist administer pressure to defined zones on the body in a patient who is in a prone, supine or side lying position. Two movement complexes will be used: “reflex creeping” and “reflex rolling”.
Primary Outcome(s)
Outcome Name: Gross motor function
Method of measuremente: Gross Motor Funcion Measure (GMFM).
Timepoint: after 2 months of treatment
Secondary Outcome(s)
Outcome Name: Therapy Dossagement
Method of measuremente: Times/day
Timepoint: after 2 months of treatment
Secondary ID(s)
ID: 1823/2018
Source(s) of Monetary Support
University of Murcia
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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