Neuroproprioceptive "Facilitation, Inhibition" and Brain Plasticity
NEFAI
Neuroproprioceptive Facilitation and Inhibition Physical Therapy Activates Adaptive and Plastic Changes in the Central Nervous System
1 other identifier
interventional
92
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started May 2015
Longer than P75 for not_applicable multiple-sclerosis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 18, 2020
CompletedFirst Posted
Study publicly available on registry
April 21, 2020
CompletedResults Posted
Study results publicly available
July 17, 2020
CompletedJuly 17, 2020
July 1, 2020
2 years
April 18, 2020
May 28, 2020
July 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Berg Balance Scale, BBS
2 months
Timed up and go Test, TUG
2 months
the 12-item Multiple Sclerosis Walking Scale, MSWS - 12
2 months
the 29-item Multiple Sclerosis Impact Scale, MSIS -29
2 months
Study Arms (3)
Motor program activating therapy
EXPERIMENTALMPAT 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.
Vojta's reflex locomotion
EXPERIMENTALVRL 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
EXPERIMENTALFunctional 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.
Interventions
Pacients underwent two months' therapy consisted of 16 face-to-face sessions (1 hour, twice a week for two months).
Pacients underwent two months' therapy consisted of 16 face-to-face sessions (1 hour, twice a week for two months).
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- other neurological disease or conditions disabling movement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 33565742DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Different availability to undergo therapy and limited supply of the FES device leading to non-uniform distribution of participants within groups; Technical problems with measurement of DTI leading to unreliable or uninterpretable data.
Results Point of Contact
- Title
- PhDr. Kamila Řasová, Ph.D.
- Organization
- Third Faculty of Medicine, Charles University
Study Officials
- PRINCIPAL INVESTIGATOR
Kamila Řasová, Ph.D.
Third Faculty of Mecicine, Charles Univerzity
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assoc. prof. Kamila Řasová, Ph.D.
Study Record Dates
First Submitted
April 18, 2020
First Posted
April 21, 2020
Study Start
May 20, 2015
Primary Completion
May 20, 2017
Study Completion
August 1, 2019
Last Updated
July 17, 2020
Results First Posted
July 17, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share