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

NCT06092619 | Unknown

• 1 other identifier: VojtaTherapy
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Motor Disorders

Keywords

Vojta Therapy; Neuromotor disorders; Motor function; Children

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Date of birth

  Baseline

• Diagnosis

  Baseline

• Number of previous physiotherapeutic treatments

  Baseline

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients under Vojta Therapy intervention

Other: Vojta Therapy

Control Group

ACTIVE COMPARATOR

Patients under regular physiotherapy intervention

Other: Conventional physiotherapy:

Interventions

Vojta Therapy OTHER

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 Group

Conventional physiotherapy: OTHER

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.

Control Group

Eligibility Criteria

• Age: 0 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female children
• Diagnosis of cerebral palsy or neuromotor disease

You may not qualify if:

• healthy subjects
• Patients receiving other therapy during the procedure

Sponsors & Collaborators

• University of Salamanca: lead

Related Publications (1)

• Menendez-Pardinas M, Alonso-Bidegain M, Santonja-Medina F, Sanchez-Gonzalez JL, Sanz-Mengibar JM. Effects of Vojta Therapy on the Motor Function of Children with Neuromotor Disorders: Study Protocol for a Randomized Controlled Trial. J Clin Med. 2023 Nov 28;12(23):7373. doi: 10.3390/jcm12237373.

  PMID: 38068424 DERIVED

MeSH Terms

Conditions

Motor Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Juan Luis Sánchez González

CONTACT

660738949; juanluissanchez@usal.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator: Juan Luis Sánchez González

Model Details: 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).

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 23, 2023
• Study Start: January 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share