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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03887507
Other study ID # NUMEN
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 21, 2019
Est. completion date May 12, 2019

Study information

Verified date March 2019
Source NUMEN Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date May 12, 2019
Est. primary completion date March 28, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Spain NUMEN Foundation Madrid España

Sponsors (3)

Lead Sponsor Collaborator
NUMEN Foundation Fisiovillalba Clinical center, Multiple Sclerosis Foundation of Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 10 metres walk This Test measures the speed during 10 meter walking at normal pace 2 weeks
Secondary Tandem 6 metres test This test measures the balance when walking with one foot in front of the other 2 weeks
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