search
Back to results

Effects of Vojta Therapy on the Motor Function of Children With Neuromotor Disorders

Primary Purpose

Motor Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vojta Therapy
Conventional physiotherapy:
Sponsored by
University of Salamanca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Motor Disorders focused on measuring Vojta Therapy, Neuromotor disorders, Motor function, Children

Eligibility Criteria

0 Months - 36 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male and female children Diagnosis of cerebral palsy or neuromotor disease Exclusion Criteria: healthy subjects Patients receiving other therapy during the procedure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Intervention Group

    Control Group

    Arm Description

    Patients under Vojta Therapy intervention

    Patients under regular physiotherapy intervention

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Date of birth
    It will be registered at the beginning of the study in order to calculate the age of the participant.
    Diagnosis
    It will be registered at the beginning of the study in order to calculate the diagnosis of the participant.
    Number of previous physiotherapeutic treatments
    Data will be collected on participants' previous treatments: Occupational Therapy; Hydrotherapy; Surgery and Botulinum toxin

    Full Information

    First Posted
    October 9, 2023
    Last Updated
    October 14, 2023
    Sponsor
    University of Salamanca
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06092619
    Brief Title
    Effects of Vojta Therapy on the Motor Function of Children With Neuromotor Disorders
    Official Title
    Effects of Vojta Therapy on the Motor Function of Children With Neuromotor Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    December 30, 2024 (Anticipated)
    Study Completion Date
    June 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Salamanca

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Motor Disorders
    Keywords
    Vojta Therapy, Neuromotor disorders, Motor function, Children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A randomized clinical trial has been designed that will assess gross motor function from the start of the rehabilitation intervention (with Vojta therapy or other methodologies).
    Masking
    Outcomes Assessor
    Masking Description
    Neither the therapists nor the evaluators of the GMFM may be blinded to the type of treatment administered due to the organization of the Rehabilitation service where the study is carried out, as well as the "face-to-face" requirements for carrying out the Vojta therapy and the evaluation. of that scale. However, the assessment of the Infant Motor Profile (IMP) is performed by observing a protocolized video recording. This would allow the quantification of this escape by an evaluator external to the service (in this case the external Principal Investigator). This would allow not only to blind the evaluator regarding the type of intervention that the child receives, but also if the video belongs to pre or post intervention. To do this, the videos will be sent encrypted and randomized for quantification
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    Patients under Vojta Therapy intervention
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    Patients under regular physiotherapy intervention
    Intervention Type
    Other
    Intervention Name(s)
    Vojta Therapy
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Conventional physiotherapy:
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Gross Motor Function Measure (GMFM).
    Description
    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.
    Time Frame
    Baseline and immediately after the intervention
    Title
    Infant Motor Profile (IMP) scale
    Description
    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.
    Time Frame
    Baseline and immediately after the intervention
    Secondary Outcome Measure Information:
    Title
    Date of birth
    Description
    It will be registered at the beginning of the study in order to calculate the age of the participant.
    Time Frame
    Baseline
    Title
    Diagnosis
    Description
    It will be registered at the beginning of the study in order to calculate the diagnosis of the participant.
    Time Frame
    Baseline
    Title
    Number of previous physiotherapeutic treatments
    Description
    Data will be collected on participants' previous treatments: Occupational Therapy; Hydrotherapy; Surgery and Botulinum toxin
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Months
    Maximum Age & Unit of Time
    36 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male and female children Diagnosis of cerebral palsy or neuromotor disease Exclusion Criteria: healthy subjects Patients receiving other therapy during the procedure
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Juan Luis Sánchez González
    Phone
    660738949
    Email
    juanluissanchez@usal.es

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Effects of Vojta Therapy on the Motor Function of Children With Neuromotor Disorders

    We'll reach out to this number within 24 hrs