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Vojta Therapy in Multiple Sclerosis.

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ClinicalTrials.gov Identifier: NCT03887507
Recruitment Status : Completed
First Posted : March 25, 2019
Last Update Posted : May 21, 2019
Sponsor:
Collaborators:
Multiple Sclerosis Foundation of Madrid
Fisiovillalba Clinical center
Information provided by (Responsible Party):
Luis Perales Lopez, NUMEN Foundation

Study Description
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Brief Summary:
This Study evaluates the effectiveness of a Vojta locomotion reflex program as short-term automatic postural control in patients with Multiple sclerosis

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Physical Therapy Other: Vojta Therapy Other: Standard Program Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Implementation of a Reflex Locomotion Program According to Vojta Produces Short-term Automatic Postural Control Changes in Patients With Multiple Sclerosis.
Actual Study Start Date : January 21, 2019
Actual Primary Completion Date : March 28, 2019
Actual Study Completion Date : May 12, 2019

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Arms and Interventions
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Arm Intervention/treatment
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.
 Other: Vojta Therapy
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.
Active Comparator: Standard Therapy
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.
 Other: Standard Program
The program consist in balance exercises targeting core stability, exercises of coordination and Pilates as well as individual sessions using the Bobath concept.


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 10 metres walk [ Time Frame: 2 weeks ]
    This Test measures the speed during 10 meter walking at normal pace


Secondary Outcome Measures :
  1. Tandem 6 metres test [ Time Frame: 2 weeks ]
    This test measures the balance when walking with one foot in front of the other


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887507


Locations
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Spain
NUMEN Foundation
Madrid, España, Spain, 28027
Sponsors and Collaborators
NUMEN Foundation
Multiple Sclerosis Foundation of Madrid
Fisiovillalba Clinical center
Investigators
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Study Chair: Natalia Valdez Palmero, Degree Rehabilitation Clinic Fisiovillalba
Study Chair: Laura Garcia Ruano, coordinator Multiple Sclerosis Foundation of Madrid
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Luis Perales Lopez, Physiotherapy service coordinator, NUMEN Foundation
ClinicalTrials.gov Identifier: NCT03887507    
Other Study ID Numbers: NUMEN
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Luis Perales Lopez, NUMEN Foundation:
Vojta therapy
core stability
postural balance
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases