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
About this trial
This is an interventional treatment trial for Motor Disorders focused on measuring Vojta Therapy, Neuromotor disorders, Motor function, Children
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
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
NCT ID
NCT06092619
First Posted
October 9, 2023
Last Updated
October 14, 2023
Sponsor
University of Salamanca
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
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Effects of Vojta Therapy on the Motor Function of Children With Neuromotor Disorders
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