Back to resultsNeuroproprioceptive "Facilitation, Inhibition" and Brain Plasticity (NEFAI)
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motor program activating therapy
Vojta's reflex locomotion
Functional electric stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring multiple sclerosis, physical therapy, white matter integrity, neuroproprioceptive "facilitation, inhibition", functional recovery, network reorganization, neurohormones, dehydroepiandrosterone
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Motor program activating therapy
Vojta's reflex locomotion
Functional electric stimulation
Arm Description
MPAT is method developed and verified by our team. In this therapy, patients are corrected into a postural position where the joints are functionally centered. Somatosensory (manual and verbal) stimuli are then applied to activate motor programs in the brain, which then lead to the co-contraction of the patient's whole body when laying, sitting, standing up or moving forward. Activated programs are repeated under various conditions and in different situations and environments to teach the patients to automatically use the acquired motor skills in daily life. Therapy was realized within the ambulatory area of the Department of Neurology at Kralovske Vinohrady University Hospital in Prague.
VRL is a standard approach for patients with MS in the Czech Republic. In the therapy, global patterns of the reflex locomotion are activated by stimulation of specific zones, with the individual placed in a precisely determined initial position (supine, prone and side laying, low kneeling position). These movement patterns have the qualities of the forward movement (locomotion) and the movement responses are precisely defined. Reflex locomotion (reflex turning and reflex creeping) is used in therapy to activate involuntarily responses of muscle function, which are necessary for spontaneous movements. Therapy was realized at the Department of Rehabilitation and Sport Medicine at Motol University Hospital.
Functional electric stimulation in the postural corrected position was developed at our workplace. Participants first underwent individual two-hour session consisting of postural correction using MPAT and the device (The WalkAide® System, Innovative Neurotronics Inc., 4999 Aircenter Circle, Suite 103 Reno, NV 89502, USA) programming (28). Patients received the device to use as much as they felt they were able to during their normal daily living activities thereafter.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Berg Balance Scale, BBS
14 items objective measure of static balance and risk of falls (0 the best, 56 the worse)
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)
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.
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).
Full Information
NCT ID
NCT04355663
First Posted
April 18, 2020
Last Updated
July 2, 2020
Sponsor
Charles University, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT04355663
Brief Title
Neuroproprioceptive "Facilitation, Inhibition" and Brain Plasticity
Acronym
NEFAI
Official Title
Neuroproprioceptive Facilitation and Inhibition Physical Therapy Activates Adaptive and Plastic Changes in the Central Nervous System
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 20, 2015 (Actual)
Primary Completion Date
May 20, 2017 (Actual)
Study Completion Date
August 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
multiple sclerosis, physical therapy, white matter integrity, neuroproprioceptive "facilitation, inhibition", functional recovery, network reorganization, neurohormones, dehydroepiandrosterone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
92 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Motor program activating therapy
Arm Type
Experimental
Arm Description
MPAT is method developed and verified by our team. In this therapy, patients are corrected into a postural position where the joints are functionally centered. Somatosensory (manual and verbal) stimuli are then applied to activate motor programs in the brain, which then lead to the co-contraction of the patient's whole body when laying, sitting, standing up or moving forward. Activated programs are repeated under various conditions and in different situations and environments to teach the patients to automatically use the acquired motor skills in daily life. Therapy was realized within the ambulatory area of the Department of Neurology at Kralovske Vinohrady University Hospital in Prague.
Arm Title
Vojta's reflex locomotion
Arm Type
Experimental
Arm Description
VRL is a standard approach for patients with MS in the Czech Republic. In the therapy, global patterns of the reflex locomotion are activated by stimulation of specific zones, with the individual placed in a precisely determined initial position (supine, prone and side laying, low kneeling position). These movement patterns have the qualities of the forward movement (locomotion) and the movement responses are precisely defined. Reflex locomotion (reflex turning and reflex creeping) is used in therapy to activate involuntarily responses of muscle function, which are necessary for spontaneous movements. Therapy was realized at the Department of Rehabilitation and Sport Medicine at Motol University Hospital.
Arm Title
Functional electric stimulation
Arm Type
Experimental
Arm Description
Functional electric stimulation in the postural corrected position was developed at our workplace. Participants first underwent individual two-hour session consisting of postural correction using MPAT and the device (The WalkAide® System, Innovative Neurotronics Inc., 4999 Aircenter Circle, Suite 103 Reno, NV 89502, USA) programming (28). Patients received the device to use as much as they felt they were able to during their normal daily living activities thereafter.
Intervention Type
Behavioral
Intervention Name(s)
Motor program activating therapy
Intervention Description
Pacients underwent two months' therapy consisted of 16 face-to-face sessions (1 hour, twice a week for two months).
Intervention Type
Behavioral
Intervention Name(s)
Vojta's reflex locomotion
Intervention Description
Pacients underwent two months' therapy consisted of 16 face-to-face sessions (1 hour, twice a week for two months).
Intervention Type
Behavioral
Intervention Name(s)
Functional electric stimulation
Intervention Description
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 Outcome Measure Information:
Title
White Matter Integrity
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Berg Balance Scale, BBS
Description
14 items objective measure of static balance and risk of falls (0 the best, 56 the worse)
Time Frame
2 months
Title
Timed up and go Test, TUG
Description
time necessary to stand up, go 3 meters, turn around, go back and sit to chair (longer time in seconds is worse function)
Time Frame
2 months
Title
the 12-item Multiple Sclerosis Walking Scale, MSWS - 12
Description
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.
Time Frame
2 months
Title
the 29-item Multiple Sclerosis Impact Scale, MSIS -29
Description
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).
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamila Řasová, Ph.D.
Organizational Affiliation
Third Faculty of Mecicine, Charles Univerzity
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33565742
Citation
Rasova K, Buckova B, Prokopiusova T, Prochazkova M, Angel G, Markova M, Hruskova N, Stetkarova I, Spanhelova S, Mares J, Tintera J, Zach P, Musil V, Hlinka J. A Three-Arm Parallel-group Exploratory Trial documents balance improvement without much evidence of white matter integrity changes in people with multiple sclerosis following two months ambulatory neuroproprioceptive "facilitation and inhibition" physical therapy. Eur J Phys Rehabil Med. 2021 Dec;57(6):889-899. doi: 10.23736/S1973-9087.21.06701-0. Epub 2021 Feb 10.
Results Reference
derived
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Neuroproprioceptive "Facilitation, Inhibition" and Brain Plasticity
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