Multiple SclerosisNCT03887507
Vojta Therapy in Multiple Sclerosis.
A study testing Vojta Therapy and Standard Program in people with Multiple Sclerosis and Physical Therapy, run by NUMEN Foundation at 1 site in Spain.
Trial summary
This Study evaluates the effectiveness of a Vojta locomotion reflex program as short-term automatic postural control in patients with Multiple sclerosis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Physical Therapy
- What is being tested?
- Vojta Therapy and Standard Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSpain
- Study dates
- 21 Jan 2019to 12 May 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Final diagnosis of MS according to McDonald criteria.
- Walkability with or without assistance (4.0 to 6.5 in EDSS) and dysfunctions defined by the inability to hold the tandem position for 30 seconds with the arms close to body.
- Older than 18 years-old.
- Escorted sessions, a family member or close person.
Who cannot join
- Phase outbreak or outbreak in the 3 months before the study.
- Medication that prevents or limits the performance of the Locomotion reflex.
- Participation in other studies during the conduct of this study.
- Score inferior to 6 in the Abbreviated Mental Test that prevents understanding of the study consent or that limits the understanding of the test during its realisation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Implementation of a Reflex Locomotion Program According to Vojta Produces Short-term Automatic Postural Control Changes in Patients With Multiple Sclerosis.
This Study evaluates the effectiveness of a Vojta locomotion reflex program as short-term automatic postural control in patients with Multiple sclerosis
Read the detailed description
In two consecutive weeks two interventions will be conducted: Vojta group(A) and standard therapy group(B). The last one is based on balance exercises targeting core stability, Bobath concept and sensory strategies. In the Vojta group 5 sessions will be conducted for a duration of 2 weeks and the same will be realised on the standard group. In addition, during the study, a daily activity shall be prescribed in both groups: Vojta exercise during 20 minutes for group A and walking for 20 minutes in group B.
- Conditions
- Multiple Sclerosis, Physical Therapy
- Being tested
- Vojta Therapy, Standard Program
- Keywords
- Vojta therapy, core stability, postural balance
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vojta TherapyOther
Each session will consist of a 45-minute Vojta thera between py protocol based on three exercises, 15 minutes per exercise: Crawling reflex, and 1st phase and 2nd phase Rolling reflex.
Standard ProgramOther
The program consist in balance exercises targeting core stability, exercises of coordination and Pilates as well as individual sessions using the Bobath concept.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | There will be 3 Vojta therapy sessions conducted on 2 consecutive weeks with an interval of 7 dayssessions, on 1st, 7th and 14th days. Each session will consist of a 45-minute Vojta thera between py protocol based on three exercises, 15 minutes per exercise: Crawling Réflex, and 1st phase and 2nd phase Rolling reflex. The relative or close person will be instructed to carry out an exercise protocol to do at home every day for 20 minutes during the 2-week study. All interventions will be made by the principal investigator. Receives: Other: Vojta Therapy |
| Standard Therapy | Active comparator | The standard group shall perform 4 sessions of physiotherapy in the same period for two consecutive weeks, with one hour per session in its specialized MS association, on 1st, 3rd, 8th, 10th and 15th days. This will be applied by experienced physiotherapists during the treatment of people with MS. The program will consist in balance exercises targeting core stability, exercises of coordination and Pilates as well as individual sessions using the Bobath concept. Patients in this group will walk at least for 20 minutes per day during the study period. Receives: Other: Standard Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
This test measures the automatic postural control. The Berg scale comprises 14 items (score included 0-4). The total scores can range from 0 (severely affected balance) to 56 (excellent balance).
Measured: 2 weeks
10 metres walk
This Test measures the speed during 10 meter walking at normal pace
Measured: 2 weeks
Secondary outcomes (1)
Tandem 6 metres test
This test measures the balance when walking with one foot in front of the other
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start21 Jan 2019
- Primary completion28 Mar 2019
- Study completion12 May 2019
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- NUMEN Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Multiple Sclerosis Foundation of Madrid, Fisiovillalba Clinical center
- Responsible party
- Principal investigator, Luis Perales Lopez, NUMEN Foundation
- Investigators
- Natalia Valdez Palmero, Degree, Study chair, Rehabilitation Clinic FisiovillalbaLaura Garcia Ruano, coordinator, Study chair, Multiple Sclerosis Foundation of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03887507
- Sponsor's protocol ID
- NUMEN
- Status last verified
- Mar 2019
- First submitted
- 21 Mar 2019
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lopez LP, Palmero NV, Ruano LG, San Leon Pascual C, Orile PW, Down AV, Gor Garcia-Fogeda MD, Tore S. The implementation of a reflex locomotion program according to Vojta produces short-term automatic postural control changes in patients with multiple sclerosis. J Bodyw Mov Ther. 2021 Apr;26:401-405. doi: 10.1016/j.jbmt.2021.01.001. Epub 2021 Jan 9.
PubMed 33992274
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implementation of a Reflex Locomotion Program According to Vojta Produces Short-term Automatic Postural Control Changes in Patients With Multiple Sclerosis.
- ClinicalTrials.gov ID
- NCT03887507
- Acronym / sponsor ID
- NUMEN
- Conditions
- Multiple Sclerosis, Physical Therapy
- Keywords
- Vojta therapy, core stability, postural balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- NUMEN FoundationUniversity, hospital or other
- Collaborators
- Multiple Sclerosis Foundation of Madrid, Fisiovillalba Clinical center
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 12 May 2019 (actual)
- First posted
- 25 Mar 2019 (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.
This Study evaluates the effectiveness of a Vojta locomotion reflex program as short-term automatic postural control in patients with Multiple sclerosis
Detailed description
In two consecutive weeks two interventions will be conducted: Vojta group(A) and standard therapy group(B). The last one is based on balance exercises targeting core stability, Bobath concept and sensory strategies. In the Vojta group 5 sessions will be conducted for a duration of 2 weeks and the same will be realised on the standard group. In addition, during the study, a daily activity shall be prescribed in both groups: Vojta exercise during 20 minutes for group A and walking for 20 minutes in group B.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Vojta TherapyThere will be 3 Vojta therapy sessions conducted on 2 consecutive weeks with an interval of 7 dayssessions, on 1st, 7th and 14th days. Each session will consist of a 45-minute Vojta thera between py protocol based on three exercises, 15 minutes per exercise: Crawling Réflex, and 1st phase and 2nd phase Rolling reflex. The relative or close person will be instructed to carry out an exercise protocol to do at home every day for 20 minutes during the 2-week study. All interventions will be made by the principal investigator. |
| Standard Therapy | Active comparator | Other: Standard ProgramThe standard group shall perform 4 sessions of physiotherapy in the same period for two consecutive weeks, with one hour per session in its specialized MS association, on 1st, 3rd, 8th, 10th and 15th days. This will be applied by experienced physiotherapists during the treatment of people with MS. The program will consist in balance exercises targeting core stability, exercises of coordination and Pilates as well as individual sessions using the Bobath concept. Patients in this group will walk at least for 20 minutes per day during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Final diagnosis of MS according to McDonald criteria.
- Walkability with or without assistance (4.0 to 6.5 in EDSS) and dysfunctions defined by the inability to hold the tandem position for 30 seconds with the arms close to body.
- Older than 18 years-old.
- Escorted sessions, a family member or close person.
Key exclusion criteria (4 listed)
- Phase outbreak or outbreak in the 3 months before the study.
- Medication that prevents or limits the performance of the Locomotion reflex.
- Participation in other studies during the conduct of this study.
- Score inferior to 6 in the Abbreviated Mental Test that prevents understanding of the study consent or that limits the understanding of the test during its realisation.
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 TherapyEach session will consist of a 45-minute Vojta thera between py protocol based on three exercises, 15 minutes per exercise: Crawling reflex, and 1st phase and 2nd phase Rolling reflex. | Other | Experimental |
| Standard ProgramThe program consist in balance exercises targeting core stability, exercises of coordination and Pilates as well as individual sessions using the Bobath concept. | Other | Standard Therapy |
Primary outcome
Berg Balance Scale
Time frame: 2 weeks
This test measures the automatic postural control. The Berg scale comprises 14 items (score included 0-4). The total scores can range from 0 (severely affected balance) to 56 (excellent balance).
10 metres walk
Time frame: 2 weeks
This Test measures the speed during 10 meter walking at normal pace
1 secondary outcome
Tandem 6 metres test
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Derived from this study: PubMed 33992274Lopez LP, Palmero NV, Ruano LG, San Leon Pascual C, Orile PW, Down AV, Gor Garcia-Fogeda MD, Tore S. The implementation of a reflex locomotion program according to Vojta produces short-term automatic postural control changes in patients with multiple sclerosis. J Bodyw Mov Ther. 2021 Apr;26:401-405. doi: 10.1016/j.jbmt.2021.01.001. Epub 2021 Jan 9.
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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.
Natalia Valdez Palmero, Degree study chair
Rehabilitation Clinic Fisiovillalba
Laura Garcia Ruano, coordinator study chair
Multiple Sclerosis Foundation of Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vojta Therapy and Standard Program in people with Multiple Sclerosis and Physical Therapy, run by NUMEN Foundation at 1 site in Spain.
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 4 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: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Berg Balance Scale (time frame: 2 weeks). 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 NCT03887507, 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 21 May 2019.