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Completed

NCT Number: NCT03887507

Vojta Therapy in Multiple Sclerosis.

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Physical Therapy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NUMEN Foundation

Madrid, España, 28027, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  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 outcomes

  1. Tandem 6 metres test

    Time frame: 2 weeks

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

Sponsors and collaborators

Lead sponsor

NUMEN Foundation

Other

Collaborators

  • Fisiovillalba Clinical center
  • Multiple Sclerosis Foundation of Madrid

Registry information

Official study title

The Implementation of a Reflex Locomotion Program According to Vojta Produces Short-term Automatic Postural Control Changes in Patients With Multiple Sclerosis.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 25, 2019
Registry last updated
May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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