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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.
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motor program activating therapy | Experimental | 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. |
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| Vojta's reflex locomotion | Experimental | 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 | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Berg Balance Scale, BBS | 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 necessary to stand up, go 3 meters, turn around, go back and sit to chair (longer time in seconds is worse function) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamila Řasová, Ph.D. | Third Faculty of Mecicine, Charles Univerzity | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33565742 | Derived | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
92 patients were allocated into three groups; from these 71 participants finished their therapeutic programs. Data of ten patients were discarded upon the visual control, due to the low quality of DTI acquisition resulting in 61 participants entering the central analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 months |
|
through study completion, an average of 2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| falling | Nervous system disorders | Systematic Assessment | an increased number of falls |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| PhDr. Kamila Řasová, Ph.D. | Third Faculty of Medicine, Charles University | +420604511416 | kamila.rasova@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 19, 2014 | Jun 14, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D007266 | Inhibition, Psychological |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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|
| 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. |
|
| 2 months |
| 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. | 2 months |
| 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). | 2 months |
| Withdrawal by Subject |
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| length of disease | Mean | Standard Deviation | years |
|
| EDSS | The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability (minimum 0 - the worse, maximum 10 - the best). Scoring is based on an examination by a neurologist. | Median | Inter-Quartile Range | units on a scale |
|
| 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. |
| OG001 | 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. |
| OG002 | 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. |
|
|
| Secondary | Berg Balance Scale, BBS | 14 items objective measure of static balance and risk of falls (0 the best, 56 the worse) | Posted | Mean | Standard Deviation | score on a scale | 2 months |
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | sec | 2 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 2 months |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | score on a scale | 2 months |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | 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. | 0 | 42 | 0 | 42 | 0 | 42 |
| EG002 | 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. | 0 | 21 | 1 | 21 | 0 | 21 |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |