Neuroproprioceptive "Facilitation, Inhibition" and Brain Plasticity

Multiple Sclerosis Clinical Trial

— NEFAI  

Official title:

Neuroproprioceptive Facilitation and Inhibition Physical Therapy Activates Adaptive and Plastic Changes in the Central Nervous System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04355663
• Other study ID #: VP/22/0/2014
• Status: Completed
• Phase: N/A
• Start date: May 20, 2015
• Est. completion date: August 1, 2019

Study information

• Verified date: July 2020
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates whether neuroproprioceptive "facilitation, inhibition" physical therapy induces plastic and adaptive processes of the CNS (white matter integrity changes), if they relate to clinical improvement, and whether therapeutic effect differs between different kinds of therapies.

Description:

In the Multi-Arm Parallel-Group Exploratory Trial, patients with multiple sclerosis were divided into three groups by an independent study coordinator, and underwent three kinds of neuroproprioceptive "facilitation, inhibition" physical therapy. At baseline and after the end of the two months' therapeutic program, a blinded assessor evaluated clinical outcomes and data from DTI .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: August 1, 2019
• Est. primary completion date: May 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• prevailed spastic paraparesis, stable clinical status and treatment in the preceding 3 months determined by neurologist,

• Expanded Disability Status Scale score (EDSS) max. 7.5

Exclusion Criteria:

• other neurological disease or conditions disabling movement

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Motor program activating therapy
Pacients underwent two months' therapy consisted of 16 face-to-face sessions (1 hour, twice a week for two months).
• Vojta's reflex locomotion
Pacients underwent two months' therapy consisted of 16 face-to-face sessions (1 hour, twice a week for two months).
• Functional electric stimulation
Pacients uderwent two months' therapy. They used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions of Motor program activating therapy.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	White Matter Integrity	Magnetic resonance imaging on a 3T magnetic resonance scanner (Siemens Trio Tim, Erlangen, Germany) using a 12-channel phased-array head coil. A diffusion tensor was fitted to each voxel of the brain, and a fractional anisotropy (FA) map was created for each subject. The images were further analyzed using tract-based spatial statistics (TBSS).; Fractional anisotropy (FA) is a scalar value between zero and one that describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions. FA is a measure often used in diffusion imaging where it is thought to reflect fiber density, axonal diameter, and myelination in white matter. The FA is an extension of the concept of eccentricity of conic sections in 3 dimensions, normalized to the unit range.	2 months
Secondary	Berg Balance Scale, BBS	14 items objective measure of static balance and risk of falls (0 the best, 56 the worse)	2 months
Secondary	Timed up and go Test, TUG	time necessary to stand up, go 3 meters, turn around, go back and sit to chair (longer time in seconds is worse function)	2 months
Secondary	the 12-item Multiple Sclerosis Walking Scale, MSWS - 12	The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation.; A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100. Walking improvement on the MSWS-12 is indicated by negative change scores.	2 months
Secondary	the 29-item Multiple Sclerosis Impact Scale, MSIS -29	a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5"extremely". Each of the two scales are scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates greater impact of disease on daily function (worse health).	2 months