Vojta Therapy in Multiple Sclerosis.

NCT03887507 | Completed

• 1 other identifier: NUMEN
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis; Physical Therapy

Keywords

Vojta therapy; core stability; postural balance

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Tandem 6 metres test

  2 weeks

Study Arms (2)

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

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.

Other: Standard Program

Interventions

Vojta Therapy OTHER

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.

Experimental

Standard Program OTHER

The program consist in balance exercises targeting core stability, exercises of coordination and Pilates as well as individual sessions using the Bobath concept.

Standard Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NUMEN Foundation: lead
• Multiple Sclerosis Foundation of Madrid: collaborator
• Fisiovillalba Clinical center: collaborator

Study Sites (1)

NUMEN Foundation

Madrid, España, 28027, Spain

Location

Related Publications (1)

• 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.

  PMID: 33992274 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Natalia Valdez Palmero, Degree

  Rehabilitation Clinic Fisiovillalba

  STUDY CHAIR

• Laura Garcia Ruano, coordinator

  Multiple Sclerosis Foundation of Madrid

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapy service coordinator

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 25, 2019
• Study Start: January 21, 2019
• Primary Completion: March 28, 2019
• Study Completion: May 12, 2019
• Last Updated: May 21, 2019

Record last verified: 2019-03

Locations

ES (1)