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Vojta Therapy in Multiple Sclerosis.

Primary Purpose

Multiple Sclerosis, Physical Therapy

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Vojta Therapy
Standard Program
Sponsored by
NUMEN Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Vojta therapy, core stability, postural balance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NUMEN Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Standard Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
10 metres walk
This Test measures the speed during 10 meter walking at normal pace

Secondary Outcome Measures

Tandem 6 metres test
This test measures the balance when walking with one foot in front of the other

Full Information

First Posted
March 21, 2019
Last Updated
May 18, 2019
Sponsor
NUMEN Foundation
Collaborators
Multiple Sclerosis Foundation of Madrid, Fisiovillalba Clinical center
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1. Study Identification

Unique Protocol Identification Number
NCT03887507
Brief Title
Vojta Therapy in Multiple Sclerosis.
Official Title
The Implementation of a Reflex Locomotion Program According to Vojta Produces Short-term Automatic Postural Control Changes in Patients With Multiple Sclerosis.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 21, 2019 (Actual)
Primary Completion Date
March 28, 2019 (Actual)
Study Completion Date
May 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NUMEN Foundation
Collaborators
Multiple Sclerosis Foundation of Madrid, Fisiovillalba Clinical center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Physical Therapy
Keywords
Vojta therapy, core stability, postural balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Vojta Therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Program
Intervention Description
The program consist in balance exercises targeting core stability, exercises of coordination and Pilates as well as individual sessions using the Bobath concept.
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
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).
Time Frame
2 weeks
Title
10 metres walk
Description
This Test measures the speed during 10 meter walking at normal pace
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Tandem 6 metres test
Description
This test measures the balance when walking with one foot in front of the other
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalia Valdez Palmero, Degree
Organizational Affiliation
Rehabilitation Clinic Fisiovillalba
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Laura Garcia Ruano, coordinator
Organizational Affiliation
Multiple Sclerosis Foundation of Madrid
Official's Role
Study Chair
Facility Information:
Facility Name
NUMEN Foundation
City
Madrid
State/Province
España
ZIP/Postal Code
28027
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
33992274
Citation
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.
Results Reference
derived

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Vojta Therapy in Multiple Sclerosis.

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