Vojta Therapy in Multiple Sclerosis.

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

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Physical Therapy
• Intervention / Treatment: Other: Vojta Therapy; Other: Standard Program

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • España
    • Madrid, España, Spain, 28027
      • NUMEN Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 weeks
10 metres walk	This Test measures the speed during 10 meter walking at normal pace	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tandem 6 metres test	This test measures the balance when walking with one foot in front of the other	2 weeks

Collaborators and Investigators

• Sponsor: NUMEN Foundation
• Collaborators: Multiple Sclerosis Foundation of Madrid; Fisiovillalba Clinical center
• Investigators: Study Chair: Natalia Valdez Palmero, Degree, Rehabilitation Clinic Fisiovillalba; Study Chair: Laura Garcia Ruano, coordinator, Multiple Sclerosis Foundation of Madrid

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2019
• Primary Completion (Actual): March 28, 2019
• Study Completion (Actual): May 12, 2019

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 25, 2019

Study Record Updates

• Last Update Posted (Actual): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: postural balance; core stability; Vojta therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: NUMEN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No