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Completed

NCT Number: NCT04355663

Neuroproprioceptive "Facilitation, Inhibition" and Brain Plasticity

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Inhibition, Psychological Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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 .

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Motor Program Activating Therapy

Behavioral

Pacients underwent two months' therapy consisted of 16 face-to-face sessions (1 hour, twice a week for two months).

Vojta's reflex locomotion

Behavioral

Pacients underwent two months' therapy consisted of 16 face-to-face sessions (1 hour, twice a week for two months).

Functional electric stimulation

Behavioral

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.

Primary outcomes

  1. White Matter Integrity

    Time frame: 2 months

    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.

Secondary outcomes

  1. Berg Balance Scale, BBS

    Time frame: 2 months

    14 items objective measure of static balance and risk of falls (0 the best, 56 the worse)

  2. Timed up and go Test, TUG

    Time frame: 2 months

    time necessary to stand up, go 3 meters, turn around, go back and sit to chair (longer time in seconds is worse function)

  3. the 12-item Multiple Sclerosis Walking Scale, MSWS - 12

    Time frame: 2 months

    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.

  4. the 29-item Multiple Sclerosis Impact Scale, MSIS -29

    Time frame: 2 months

    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).

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

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

Acronym: NEFAI

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
Apr 21, 2020
Registry last updated
Jul 17, 2020

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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