Vojta Therapy in Multiple Sclerosis.

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Physical Therapy
• Interventions: Other: Vojta Therapy; Other: Standard Program

• Registration Number: NCT03887507
• Lead Sponsor: NUMEN Foundation

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.

Study Timeline

• Study Start: 2019-01-21
• Status Verified: 2019-03
• Study First Submitted: 2019-03-21
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-25
• Primary Completion: 2019-03-28
• Study Completion: 2019-05-12
• Last Update Submitted: 2019-05-18
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Vojta Therapy	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.
Standard Therapy	Standard Program	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.

Primary Outcome Measures

Name	Time	Method
10 metres walk	2 weeks	This Test measures the speed during 10 meter walking at normal pace
Berg Balance Scale	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).

Secondary Outcome Measures

Name	Time	Method
Tandem 6 metres test	2 weeks	This test measures the balance when walking with one foot in front of the other

Trial Locations

Locations (1)

NUMEN Foundation; 🇪🇸 Madrid, España, Spain