Motor DisordersNCT06092619
Effects of Vojta Therapy on the Motor Function of Children With Neuromotor Disorders
A study testing Vojta Therapy and Conventional physiotherapy: in people with Motor Disorders, run by University of Salamanca.
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. Read more about this study
- Who is it for?
- Ages 0 to 36 months
- Conditions the study is for
- Motor Disorders
- What is being tested?
- Vojta Therapy and Conventional physiotherapy:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female children
- Diagnosis of cerebral palsy or neuromotor disease
Who cannot join
- healthy subjects
- Patients receiving other therapy during the procedure
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- Vojta Therapy, Conventional physiotherapy:
- Keywords
- Vojta Therapy, Neuromotor disorders, Motor function, Children
- Medical subject headings
- Motor Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vojta TherapyOther
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: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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patients under Vojta Therapy intervention Receives: Other: Vojta Therapy |
| Control Group | Active comparator | Patients under regular physiotherapy intervention Receives: Other: Conventional physiotherapy: |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and immediately after the intervention
Secondary outcomes (3)
Date of birth
It will be registered at the beginning of the study in order to calculate the age of the participant.
Measured: Baseline
Diagnosis
It will be registered at the beginning of the study in order to calculate the diagnosis of the participant.
Measured: Baseline
Number of previous physiotherapeutic treatments
Data will be collected on participants' previous treatments: Occupational Therapy; Hydrotherapy; Surgery and Botulinum toxin
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Jan 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Luis Sanchez Gonzalez, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092619
- Sponsor's protocol ID
- VojtaTherapy
- Status last verified
- Oct 2023
- First submitted
- 9 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38068424
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vojta Therapy on the Motor Function of Children With Neuromotor Disorders
- ClinicalTrials.gov ID
- NCT06092619
- Acronym / sponsor ID
- VojtaTherapy
- Conditions
- Motor Disorders
- Keywords
- Vojta Therapy, Neuromotor disorders, Motor function, Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Vojta TherapyPatients under Vojta Therapy intervention |
| Control Group | Active comparator | Other: Conventional physiotherapy:Patients under regular physiotherapy intervention |
Who may qualify
- Ages
- 0 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male and female children
- Diagnosis of cerebral palsy or neuromotor disease
Key exclusion criteria (2 listed)
- healthy subjects
- Patients receiving other therapy during the procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vojta TherapyThe 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 | Other | Intervention Group |
| 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. | Other | Control Group |
Primary outcome
Gross Motor Function Measure (GMFM).
Time frame: Baseline and immediately after the intervention
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
Time frame: Baseline and immediately after the intervention
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.
3 secondary outcomes
Date of birth
Time frame: Baseline
Diagnosis
Time frame: Baseline
Number of previous physiotherapeutic treatments
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Derived from this study: PubMed 38068424Menendez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Vojta Therapy and Conventional physiotherapy: in people with Motor Disorders, run by University of Salamanca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Luis Sánchez González (660738949, juanluissanchez@usal.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Measure (GMFM). (time frame: Baseline and immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06092619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.