Back to resultsBrain Activity Changes Following Neuroproprioceptive Physiotherapy in Multiple Sclerosis
Primary Purpose
Neuronal Plasticity, Multiple Sclerosis, Rehabilitation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motor Program Activating Therapy
Vojta reflex locomotion
Sponsored by
About this trial
This is an interventional treatment trial for Neuronal Plasticity
Eligibility Criteria
Inclusion Criteria:
- definite MS
- stable clinical status in the preceding 3 months
- imuno-modulatory treatment for at least two years (including glatiramer acetate, interferon beta-1a, 1b, mitoxantrone, fingolimod, natulizumab)
- Expanded Disability Status Scale (EDSS)≤6
- predominant motor impartment
- six months or more without any physiotherapy
- ability to undergo ambulatory physiotherapy
Exlusion criteria:
-other neurological disease or conditions disabling movement
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Motor Program Activating Therapy (MPAT)
Vojta Reflex Locomotion (VRL)
healthy controls
Arm Description
The MPAT was chosen for our clinical experience - it was developed and verified by our team. In this therapy, patients are corrected into a postural position where the joints are functionally centred. Then somatosensory (manual and verbal) stimuli are applied to activate motor programs in the brain, which then lead to the co-contraction of the patient's whole body when the patient is lying, sitting, standing up or moving forward. Activated programs are repeated under various conditions and in different situations and environments to teach the patients to use the acquired motor skills automatically in daily life.
VRL was developed by prof. Vojta and is standardly used in the Czech Republic. In this therapy, patients should be set up into the precisely given initial position with defined angular setting of extremities. In each position (supine, prone, lying on the side, and low kneeling position), activation points (zones) are stimulated with precise localization and pressure direction. Such stimulation activates one of the global movement patterns (reflex turning and reflex creeping) corresponding to the initial position. In addition to motor involuntarily reaction, also sensory and autonomic response is activated.
sex and age matched healthy controls
Outcomes
Primary Outcome Measures
Brain activity
fMRI examinations on 3T magnetic resonance scanner (Siemens Trio Tim, Erlangen, Germany) using a 12-channel head coil (different pattern of brain activity in healthy and people with MS)
Brain activity
fMRI examinations on 3T magnetic resonance scanner (Siemens Trio Tim, Erlangen, Germany) using a 12-channel head coil (different pattern of brain activity before and after two months of physiotherapeutic program)
Secondary Outcome Measures
Nine Hole Peg Test - NHPT
measure finger dexterity (quicker time means better function)
Paced Auditory Serial Addition Test - PASAT
The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is presented using audio record to ensure standardization in the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The score for the PASAT is the total number correct out of 60 possible answers.
Berg Balance Scale - BBS
14 items objective measure of static balance and risk of falls (0 the best, 56 the worse)
Timed 25 Foot Walk - T25FW
The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. The score for the T25-FW is the average of the two completed trials.
Timed Up and Go - TUG
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Full Information
NCT ID
NCT04448444
First Posted
June 18, 2020
Last Updated
June 25, 2020
Sponsor
Charles University, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT04448444
Brief Title
Brain Activity Changes Following Neuroproprioceptive Physiotherapy in Multiple Sclerosis
Official Title
Brain Activity Changes Following Neuroproprioceptive Physiotherapy in Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
May 15, 2017 (Actual)
Study Completion Date
November 10, 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
Yes
5. Study Description
Brief Summary
Imaging methods bring new possibilities for describing the brain plasticity processes that underly the improvement of clinical function after physiotherapy in people with multiple sclerosis (pwMS). The study determined whether facilitation physiotherapy could enhance brain plasticity, compared two facilitation methods, and looked for any relation to clinical improvement in pwMS.
Detailed Description
The study was designed as parallel group randomized comparison of two kinds of physiotherapeutic interventions referred to healthy controls.
MS patients were examined by fMRI (primary outcomes) and clinical tests (secondary outcomes) at the beginning of study. Then, they were randomly divided into two groups (by drawing lots in a 1:1 ratio). The first group underwent Vojta reflex locomotion (VRL), and the second Motor Program Activating Physiotherapy (MPAT). The length and intensity of treatment was the same in both groups (two months, one hour twice a week). After the treatment, a clinical and fMRI examination was performed. Healthy volunteers underwent an fMRI examination that was considered to be a control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuronal Plasticity, Multiple Sclerosis, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study was designed as parallel group (outpatients) randomized comparison of two kinds of physiotherapeutic interventions referred to healthy controls.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Motor Program Activating Therapy (MPAT)
Arm Type
Experimental
Arm Description
The MPAT was chosen for our clinical experience - it was developed and verified by our team. In this therapy, patients are corrected into a postural position where the joints are functionally centred. Then somatosensory (manual and verbal) stimuli are applied to activate motor programs in the brain, which then lead to the co-contraction of the patient's whole body when the patient is lying, sitting, standing up or moving forward. Activated programs are repeated under various conditions and in different situations and environments to teach the patients to use the acquired motor skills automatically in daily life.
Arm Title
Vojta Reflex Locomotion (VRL)
Arm Type
Experimental
Arm Description
VRL was developed by prof. Vojta and is standardly used in the Czech Republic. In this therapy, patients should be set up into the precisely given initial position with defined angular setting of extremities. In each position (supine, prone, lying on the side, and low kneeling position), activation points (zones) are stimulated with precise localization and pressure direction. Such stimulation activates one of the global movement patterns (reflex turning and reflex creeping) corresponding to the initial position. In addition to motor involuntarily reaction, also sensory and autonomic response is activated.
Arm Title
healthy controls
Arm Type
No Intervention
Arm Description
sex and age matched healthy controls
Intervention Type
Behavioral
Intervention Name(s)
Motor Program Activating Therapy
Intervention Description
Patients undergo ambulatory physiotherapy - Motor Program Activating Therapy (2 months, twice a week, 1 hour of duration). Therapy was undertaken at the ambulatory section of the Department of Neurology, Kralovske Vinohrady University Hospital in Prague.
Intervention Type
Behavioral
Intervention Name(s)
Vojta reflex locomotion
Intervention Description
Patients undergo ambulatory physiotherapy - Vojta Reflex Locomotion Therapy (2 months, twice a week, 1 hour of duration). Therapy was undertaken at the Department of Rehabilitation and Sport Medicine, Motol University Hospital.
Primary Outcome Measure Information:
Title
Brain activity
Description
fMRI examinations on 3T magnetic resonance scanner (Siemens Trio Tim, Erlangen, Germany) using a 12-channel head coil (different pattern of brain activity in healthy and people with MS)
Time Frame
0 month
Title
Brain activity
Description
fMRI examinations on 3T magnetic resonance scanner (Siemens Trio Tim, Erlangen, Germany) using a 12-channel head coil (different pattern of brain activity before and after two months of physiotherapeutic program)
Time Frame
0 and 2 months
Secondary Outcome Measure Information:
Title
Nine Hole Peg Test - NHPT
Description
measure finger dexterity (quicker time means better function)
Time Frame
2 months
Title
Paced Auditory Serial Addition Test - PASAT
Description
The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is presented using audio record to ensure standardization in the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The score for the PASAT is the total number correct out of 60 possible answers.
Time Frame
2 months
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 25 Foot Walk - T25FW
Description
The T25-FW is a quantitative mobility and leg function performance test based on a timed 25-walk. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. The score for the T25-FW is the average of the two completed trials.
Time Frame
2 months
Title
Timed Up and Go - TUG
Description
The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
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
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
definite MS
stable clinical status in the preceding 3 months
imuno-modulatory treatment for at least two years (including glatiramer acetate, interferon beta-1a, 1b, mitoxantrone, fingolimod, natulizumab)
Expanded Disability Status Scale (EDSS)≤6
predominant motor impartment
six months or more without any physiotherapy
ability to undergo ambulatory physiotherapy
Exlusion 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 Medicine Charles University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Brain Activity Changes Following Neuroproprioceptive Physiotherapy in Multiple Sclerosis
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