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

NCT ID: NCT06092619

Last Updated: 2023-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Motor Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Group

Patients under Vojta Therapy intervention

Group Type EXPERIMENTAL

Vojta Therapy

Intervention Type 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

Control Group

Patients under regular physiotherapy intervention

Group Type ACTIVE_COMPARATOR

Conventional physiotherapy:

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* healthy subjects
* Patients receiving other therapy during the procedure
Minimum Eligible Age

0 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Salamanca

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Juan Luis Sanchez Gonzalez

Principal Investigator: Juan Luis Sánchez González

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Juan Luis Sánchez González

Role: CONTACT

660738949

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38068424 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VojtaTherapy

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.