- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04355663
Neuroproprioceptive "Facilitation, Inhibition" and Brain Plasticity (NEFAI)
Neuroproprioceptive Facilitation and Inhibition Physical Therapy Activates Adaptive and Plastic Changes in the Central Nervous System
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Motor program activating therapy
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.
|
Pacients underwent two months' therapy consisted of 16 face-to-face sessions (1 hour, twice a week for two months).
|
Experimental: Vojta's reflex locomotion
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.
|
Pacients underwent two months' therapy consisted of 16 face-to-face sessions (1 hour, twice a week for two months).
|
Experimental: Functional electric stimulation
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 months
|
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)
|
2 months
|
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. |
2 months
|
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).
|
2 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VP/22/0/2014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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