Multiple SclerosisNCT05558683
Effect of the Vojta Therapy in Patients Multiple Sclerosis
A study testing Randomized clinical trial. in people with Multiple Sclerosis, run by Aymara Abreu Corrales.
Trial summary
Multiple sclerosis is the most common disabling neurological disease in young adults. Inflammation, demyelination, neurodegeneration, gliosis and repair processes are involved in its process, which are responsible for the heterogeneity and individual variability in the expression of the disease, the prognosis and the… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Randomized clinical trial.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 1 Dec 2023
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persons with MS who have signed the informed consent.
- Persons of both sexes.
- Ages between 20 and 65 years.
- Subjects of both sexes diagnosed with multiple sclerosis on the EDSS (Expanded Disability Status Scale).
Who cannot join
- Persons with multiple sclerosis with EDSS scale score equal to or greater than 7.0.
- Occurrence of a flare during the period of the patient's participation in the study.
- Pregnant women.
- Oncology patients.
- Non-acceptance and non-signing of informed consent.
- Refusal to participate in the study.
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- Patients with severe cognitive impairment that does not allow them to understand the development of the study.
- Patients with cardiovascular instability.
- Patients who do not complete at least 75% of the scheduled sessions. Patients who do not present any of the contraindications contemplated for Vojta therapy.
About this study
Official title: Effect of the Vojta Therapy on Lipid Biomarkers Related to Myelin in Subjects With Multiple Sclerosis.
Multiple sclerosis is the most common disabling neurological disease in young adults. Inflammation, demyelination, neurodegeneration, gliosis and repair processes are involved in its process, which are responsible for the heterogeneity and individual variability in the expression of the disease, the prognosis and the response to treatment. Clinically, MS manifests itself with the following symptoms: sensory focus, motor focus, spasticity, balance disorders, visual disturbances such as loss of vision or double vision or sphincter dysfunction.
The main subtypes of MS are relapsing-remitting, secondary progressive, primary progressive, and progressive relapsing. Clinically, RRMS presents the initial inflammatory phase, characterized by reversible flares with neurological dysfunction, followed by periods of remission. Approximately 40-50% of these patients progress to SPMS, where the disease gradually progresses from intermittent flare-ups to steadily progressive worsening, resulting in permanent disability due to massive axonal loss. PPMS is the most severe subtype, affecting approximately 10% of all cases, and manifesting as progressive degeneration without any remission.
Read the detailed description
From the field of Physiotherapy, one of the main tools for the treatment of MS is physical exercise. Numerous studies show that exercising is safe and beneficial in people with MS, as long as it is done correctly and supervised by health professionals. Physical exercise is considered an important part of symptomatic and supportive treatment for people with MS, since it induces improvement of physiological functions affected by lack of physical activity and helps to manage some symptoms, such as spasticity, fatigue and lack of balance There are therapies within Physiotherapy that help treat MS such as the Vojta Method and the Bobath Method.
- Conditions
- Multiple Sclerosis
- Being tested
- Randomized clinical trial.
- Keywords
- Vojta Therapy, Bobath Therapy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomized clinical trial.Other
Our study will be a Randomized Clinical Trial. It will be held at the Aymara Abreu Physiotherapy Clinic center, with a maximum duration of 1 year. It will consist of two parts. In the first stage of the treatment we will carry out an initial assessment, and in the second stage a final assessment. After that, the corresponding data analysis will be carried out.
| Study group | Role | What they receive |
|---|---|---|
| Vojta Reflex Locomotion Therapy | Active comparator | The Vojta Method or Vojta Reflex Locomotion Therapy (TLRV) is a rehabilitative method for neuromusculoskeletal pathologies widely used in Europe. Its development is based on the concept of motor ontogenesis and tries to trigger innate motor reactions (reflex locomotion patterns) in the trunk and limbs from defined tactile and proprioceptive stimuli, starting from certain postures. This therapy presents differential elements with respect to other existing therapies, both for neurophysiological principles and for methodological principles. It is an active therapy, in which great concentration is required on the part of the patient, that is, both therapist and patient are the central axes of the treatment. Receives: Other: Randomized clinical trial. |
| Bobath Method | Active comparator | Within physiotherapy, the Bobath concept is a valid and recognized option in the treatment of patients with neurological disorders, and therefore, of those diagnosed with MS. It was developed by Karel and Berta Bobath. The Bobath concept is defined as a problem-solving approach in the assessment and treatment of people with impaired neuromotor function, becoming a valid tool as part of the comprehensive treatment of people with MS Receives: Other: Randomized clinical trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory function
Respiratory function will be assessed with a pressure manometer to measure peak inspiratory pressure.
Measured: 5 minutes
Spasticity
Spasticity will be measured using the Tardieu scale.
Measured: 10 minutes
Balance
The balance will be measured through the Berg scale.
Measured: 10 minutes
Age
Measured: 1 minutes
Time reaction
Reaction time will be measured by the Cognifit test
Measured: 5 minutes
Secondary outcomes (1)
Myelin
Myelin will be me measured trough the tear duct whit phospholipid test strips
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Dec 2023 (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 Multiple SclerosisStudies 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
- Single group
- Model description
- Our study will be a Randomized Clinical Trial. It will be held at the Aymara Abreu Physiotherapy Clinic center, with a maximum duration of 1 year. It will consist of two parts. In the first stage of the treatment we will carry out an initial assessment, and in the second stage a final assessment. After that, the corresponding data analysis will be carried out.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aymara Abreu Corrales
- Sponsor type
- University, hospital or other
- Collaborators
- University of Salamanca
- Responsible party
- Sponsor-investigator, Aymara Abreu Corrales, Instituto de Neurociencia de Castillas y Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05558683
- Sponsor's protocol ID
- MultipleSclerosisVojta
- Status last verified
- Sep 2022
- First submitted
- 15 Apr 2022
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abreu-Corrales A, Velasco A, Cuesta-Gomez A, Sanchez-Gonzalez JL. Impact of reflex locomotion and the Bobath concept on clinical and biomolecular parameters in people with multiple sclerosis: study protocol for a randomized controlled trial. Front Neurol. 2023 Aug 4;14:1209477. doi: 10.3389/fneur.2023.1209477. eCollection 2023.
PubMed 37602251
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Vojta Therapy on Lipid Biomarkers Related to Myelin in Subjects With Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT05558683
- Acronym / sponsor ID
- MultipleSclerosisVojta
- Conditions
- Multiple Sclerosis
- Keywords
- Vojta Therapy, Bobath Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Aymara Abreu CorralesUniversity, hospital or other
- Collaborators
- University of Salamanca
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 28 Sep 2022 (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.
Multiple sclerosis is the most common disabling neurological disease in young adults. Inflammation, demyelination, neurodegeneration, gliosis and repair processes are involved in its process, which are responsible for the heterogeneity and individual variability in the expression of the disease, the prognosis and the response to treatment. Clinically, MS manifests itself with the following symptoms: sensory focus, motor focus, spasticity, balance disorders, visual disturbances such as loss of vision or double vision or sphincter dysfunction.
The main subtypes of MS are relapsing-remitting, secondary progressive, primary progressive, and progressive relapsing. Clinically, RRMS presents the initial inflammatory phase, characterized by reversible flares with neurological dysfunction, followed by periods of remission. Approximately 40-50% of these patients progress to SPMS, where the disease gradually progresses from intermittent flare-ups to steadily progressive worsening, resulting in permanent disability due to massive axonal loss. PPMS is the most severe subtype, affecting approximately 10% of all cases, and manifesting as progressive degeneration without any remission.
Detailed description
From the field of Physiotherapy, one of the main tools for the treatment of MS is physical exercise. Numerous studies show that exercising is safe and beneficial in people with MS, as long as it is done correctly and supervised by health professionals. Physical exercise is considered an important part of symptomatic and supportive treatment for people with MS, since it induces improvement of physiological functions affected by lack of physical activity and helps to manage some symptoms, such as spasticity, fatigue and lack of balance There are therapies within Physiotherapy that help treat MS such as the Vojta Method and the Bobath Method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Our study will be a Randomized Clinical Trial. It will be held at the Aymara Abreu Physiotherapy Clinic center, with a maximum duration of 1 year. It will consist of two parts. In the first stage of the treatment we will carry out an initial assessment, and in the second stage a final assessment. After that, the corresponding data analysis will be carried out.
| Arm | Type | Receives |
|---|---|---|
| Vojta Reflex Locomotion Therapy | Active comparator | Other: Randomized clinical trial.The Vojta Method or Vojta Reflex Locomotion Therapy (TLRV) is a rehabilitative method for neuromusculoskeletal pathologies widely used in Europe. Its development is based on the concept of motor ontogenesis and tries to trigger innate motor reactions (reflex locomotion patterns) in the trunk and limbs from defined tactile and proprioceptive stimuli, starting from certain postures. This therapy presents differential elements with respect to other existing therapies, both for neurophysiological principles and for methodological principles. It is an active therapy, in which great concentration is required on the part of the patient, that is, both therapist and patient are the central axes of the treatment. |
| Bobath Method | Active comparator | Other: Randomized clinical trial.Within physiotherapy, the Bobath concept is a valid and recognized option in the treatment of patients with neurological disorders, and therefore, of those diagnosed with MS. It was developed by Karel and Berta Bobath. The Bobath concept is defined as a problem-solving approach in the assessment and treatment of people with impaired neuromotor function, becoming a valid tool as part of the comprehensive treatment of people with MS |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Persons with MS who have signed the informed consent.
- Persons of both sexes.
- Ages between 20 and 65 years.
- Subjects of both sexes diagnosed with multiple sclerosis on the EDSS (Expanded Disability Status Scale).
Key exclusion criteria (9 listed)
- Persons with multiple sclerosis with EDSS scale score equal to or greater than 7.0.
- Occurrence of a flare during the period of the patient's participation in the study.
- Pregnant women.
- Oncology patients.
- Non-acceptance and non-signing of informed consent.
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 |
|---|---|---|
| Randomized clinical trial.Our study will be a Randomized Clinical Trial. It will be held at the Aymara Abreu Physiotherapy Clinic center, with a maximum duration of 1 year. It will consist of two parts. In the first stage of the treatment we will carry out an initial assessment, and in the second stage a final assessment. After that, the corresponding data analysis will be carried out. | Other | Bobath Method, Vojta Reflex Locomotion Therapy |
Primary outcome
Respiratory function
Time frame: 5 minutes
Respiratory function will be assessed with a pressure manometer to measure peak inspiratory pressure.
Spasticity
Time frame: 10 minutes
Spasticity will be measured using the Tardieu scale.
Balance
Time frame: 10 minutes
The balance will be measured through the Berg scale.
Age
Time frame: 1 minutes
Time reaction
Time frame: 5 minutes
Reaction time will be measured by the Cognifit test
1 secondary outcome
Myelin
Time frame: 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Derived from this study: PubMed 37602251Abreu-Corrales A, Velasco A, Cuesta-Gomez A, Sanchez-Gonzalez JL. Impact of reflex locomotion and the Bobath concept on clinical and biomolecular parameters in people with multiple sclerosis: study protocol for a randomized controlled trial. Front Neurol. 2023 Aug 4;14:1209477. doi: 10.3389/fneur.2023.1209477. eCollection 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Randomized clinical trial. in people with Multiple Sclerosis, run by Aymara Abreu Corrales.
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 4 inclusion and 9 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 28 Sep 2022. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory function (time frame: 5 minutes). The study lists 5 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 NCT05558683, 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 28 Sep 2022.