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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06092619
Other study ID # VojtaTherapy
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date June 30, 2025

Study information

Verified date October 2023
Source University of Salamanca
Contact Juan Luis Sánchez González
Phone 660738949
Email juanluissanchez@usal.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Functionality and motor skills during activities of daily living have progressively gained importance as tools for classification, assessment and research of neuromotor disorders and the treatment methodology according to Dr. Vojta or Reflex Locomotion follows this criterion in the clinical field. Vojta therapy is a commonly extended tool in the field of pediatric rehabilitation. This methodology acts on the ontogenic postural function and automatic postural control, on which different environmental aspects will later act. It is not a functional training, to avoid the voluntary movement available according to the pathology by means of compensations. Vojta therapy would be the key to unlock the development of gross motor function, later used in the movement of daily life activities, including other therapies such as conventional physiotherapy, sensory stimulation, occupational therapy, etc. This study aims to demonstrate that there are changes in the motor development of children with cerebral palsy with the application of Vojta Therapy.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date June 30, 2025
Est. primary completion date December 30, 2024
Accepts healthy volunteers No
Gender All
Age group 0 Months to 36 Months
Eligibility Inclusion Criteria: - Male and female children - Diagnosis of cerebral palsy or neuromotor disease Exclusion Criteria: - healthy subjects - Patients receiving other therapy during the procedure

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Vojta Therapy
The therapist applied pressure to defined zones on the body whilst positioned in prone, supine and side lying, where the stimulus leads to automatically and involuntarily complex movement.The parents were also instructed on at least one of the exercises from the first session, after the initial assessment. The home program was progressively increased and supervised until the three therapy positions were mastered, during weekly or fortnightly follow ups. The recommended dose was four times per day at home, in session no longer than 15-20 minutes; however, the daily frequency of each family due to different availability was also taken in account. The frequency of the dose was divided into 3 groups: families who could carry on therapy a) three times per day, b) four times per day, c) one or two times per day, d) less than seven times per week or therapy at the clinic
Conventional physiotherapy:
Conventional physiotherapy intervention included goal-directed functional training based on tasks. These motor skills will be performed in enhanced and adapted settings, but as similar as possible to the usual activities of daily living. Family and children participated in the goal setting, and the approach will focus on overcoming the limitations of the activities to reach these, instead of the modification of the movement patterns. This intervention is founded in motor learning and behavioral neuroscience, focusing on participation and activity acquisition.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Salamanca

Outcome

Type Measure Description Time frame Safety issue
Primary Gross Motor Function Measure (GMFM). Gross motor function and mobility have important roles for classification, assessment and research involving children with neuromotor disorders. Gross Motor Function Measure could be currently considered as gold standard for the quantification of gross motor function in the pediatric rehabilitation. Maximum and minimum scores on the GMFM may vary depending on age and the specific dimension being assessed (0-88). In general, a score of 100% on a dimension would indicate that the child has a motor skill level equivalent to that of a nondisabled child of the same age on that dimension. Baseline and immediately after the intervention
Primary Infant Motor Profile (IMP) scale The Infant Motor Profile scale is another evidence-based method of assessing infant motor behavior. It not only quantifies motor milestones, but also movement quality by analysing five factors: variability, adaptation, symmetry, fluency, and capacity. The advantage of this scale is that the assessment is performed through video recording, allowing to have a dedicated clinical evaluator blinded to the type of intervention. There is no specific maximum or minimum IMP score value, as the scores are interpreted in relation to typical motor development skills for the child's age. In general, a higher PMI score indicates better motor development, while a lower score may suggest delays in motor development. Baseline and immediately after the intervention
Secondary Date of birth It will be registered at the beginning of the study in order to calculate the age of the participant. Baseline
Secondary Diagnosis It will be registered at the beginning of the study in order to calculate the diagnosis of the participant. Baseline
Secondary Number of previous physiotherapeutic treatments Data will be collected on participants' previous treatments: Occupational Therapy; Hydrotherapy; Surgery and Botulinum toxin Baseline
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