Trial Outcomes & Findings for Neuroproprioceptive "Facilitation, Inhibition" and Brain Plasticity (NCT NCT04355663)
NCT ID: NCT04355663
Last Updated: 2020-07-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
92 participants
Primary outcome timeframe
2 months
Results posted on
2020-07-17
Participant Flow
Recruitment was realized between May 2015 and May 2017 at Department of Neurology, Facuty Hospital Royal Vineyard. MS patients were divided into three groups by an independent study coordinator according to availability of each therapist (in Groups 1 and 2) and amount of FES devices to borrow (in Group 3), and underwent three kinds of PT.
120 people were initially assessed for eligibility. 24 people did not fit to inclusion criteria, 1 did decline to participate and 1 injured. 92 were allocated into three groups.
Participant milestones
| Measure |
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.
16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
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).
16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
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.
Patients used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
|---|---|---|---|
|
Overall Study
STARTED
|
42
|
29
|
21
|
|
Overall Study
COMPLETED
|
40
|
14
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
15
|
4
|
Reasons for withdrawal
| Measure |
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.
16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
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).
16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
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.
Patients used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
|---|---|---|---|
|
Overall Study
Physician Decision
|
2
|
7
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
8
|
3
|
Baseline Characteristics
Neuroproprioceptive "Facilitation, Inhibition" and Brain Plasticity
Baseline characteristics by cohort
| Measure |
Motor Program Activating Therapy
n=42 Participants
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.
16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
Vojta's Reflex Locomotion
n=29 Participants
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).
16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
Functional Electric Stimulation
n=21 Participants
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.
Patients used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
42.3 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
46.15 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
48.11 years
STANDARD_DEVIATION 11 • n=4 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Czechia
|
35 participants
n=5 Participants
|
13 participants
n=7 Participants
|
13 participants
n=5 Participants
|
61 participants
n=4 Participants
|
|
length of disease
|
14.2 years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
8.38 years
STANDARD_DEVIATION 5.1 • n=7 Participants
|
13.15 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
12.72 years
STANDARD_DEVIATION 7.0 • n=4 Participants
|
|
EDSS
|
4 units on a scale
n=5 Participants
|
4 units on a scale
n=7 Participants
|
4 units on a scale
n=5 Participants
|
4 units on a scale
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 monthsMagnetic 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.
Outcome measures
| Measure |
Motor Program Activating Therapy
n=42 Participants
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.
16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
Vojta's Reflex Locomotion
n=29 Participants
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).
16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
Functional Electric Stimulation
n=21 Participants
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.
Patients used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
|---|---|---|---|
|
White Matter Integrity
|
0.5023 score on a scale
Standard Deviation 0.0293
|
0.5168 score on a scale
Standard Deviation 0.0266
|
0.4747 score on a scale
Standard Deviation 0.0293
|
SECONDARY outcome
Timeframe: 2 months14 items objective measure of static balance and risk of falls (0 the best, 56 the worse)
Outcome measures
| Measure |
Motor Program Activating Therapy
n=42 Participants
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.
16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
Vojta's Reflex Locomotion
n=29 Participants
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).
16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
Functional Electric Stimulation
n=21 Participants
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.
Patients used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
|---|---|---|---|
|
Berg Balance Scale, BBS
|
49.79 score on a scale
Standard Deviation 8.1
|
47.92 score on a scale
Standard Deviation 9.8
|
32.76 score on a scale
Standard Deviation 11.2
|
SECONDARY outcome
Timeframe: 2 monthstime necessary to stand up, go 3 meters, turn around, go back and sit to chair (longer time in seconds is worse function)
Outcome measures
| Measure |
Motor Program Activating Therapy
n=42 Participants
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.
16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
Vojta's Reflex Locomotion
n=29 Participants
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).
16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
Functional Electric Stimulation
n=21 Participants
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.
Patients used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
|---|---|---|---|
|
Timed up and go Test, TUG
|
10.15 sec
Standard Deviation 5.8
|
10.31 sec
Standard Deviation 5.6
|
16.88 sec
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: 2 monthsThe 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.
Outcome measures
| Measure |
Motor Program Activating Therapy
n=42 Participants
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.
16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
Vojta's Reflex Locomotion
n=29 Participants
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).
16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
Functional Electric Stimulation
n=21 Participants
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.
Patients used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
|---|---|---|---|
|
the 12-item Multiple Sclerosis Walking Scale, MSWS - 12
|
61.57 score on a scale
Standard Deviation 12.7
|
59.77 score on a scale
Standard Deviation 18.4
|
73.94 score on a scale
Standard Deviation 20.2
|
SECONDARY outcome
Timeframe: 2 monthsa 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).
Outcome measures
| Measure |
Motor Program Activating Therapy
n=42 Participants
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.
16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
Vojta's Reflex Locomotion
n=29 Participants
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).
16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
Functional Electric Stimulation
n=21 Participants
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.
Patients used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
|---|---|---|---|
|
the 29-item Multiple Sclerosis Impact Scale, MSIS -29
|
32.93 score on a scale
Standard Deviation 8.7
|
33.38 score on a scale
Standard Deviation 13.3
|
43.47 score on a scale
Standard Deviation 12.6
|
Adverse Events
Vojta's Reflex Locomotion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Motor Program Activating Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Functional Electric Stimulation
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vojta's Reflex Locomotion
n=29 participants at risk
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).
16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
Motor Program Activating Therapy
n=42 participants at risk
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.
16 face-to-face sessions (1 hour, twice a week for two months). Group 3 used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
Functional Electric Stimulation
n=21 participants at risk
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.
Patients used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions.
|
|---|---|---|---|
|
Nervous system disorders
falling
|
0.00%
0/29 • through study completion, an average of 2 months
|
0.00%
0/42 • through study completion, an average of 2 months
|
4.8%
1/21 • through study completion, an average of 2 months
|
Other adverse events
Adverse event data not reported
Additional Information
PhDr. Kamila Řasová, Ph.D.
Third Faculty of Medicine, Charles University
Phone: +420604511416
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place