Neuronal PlasticityNCT04448444
Brain Activity Changes Following Neuroproprioceptive Physiotherapy in Multiple Sclerosis
A study testing Motor Program Activating Therapy and Vojta reflex locomotion in people with Neuronal Plasticity and Multiple Sclerosis, run by Charles University, Czech Republic.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuronal Plasticity, Multiple Sclerosis, Rehabilitation
- What is being tested?
- Motor Program Activating Therapy and Vojta reflex locomotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- May 2015to 10 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- ability to undergo ambulatory physiotherapy
- Exlusion criteria:
- -other neurological disease or conditions disabling movement
Who cannot join
None listed.
About this study
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.
Read the 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.
- Conditions
- Neuronal Plasticity, Multiple Sclerosis, Rehabilitation
- Being tested
- Motor Program Activating Therapy, Vojta reflex locomotion
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor Program Activating TherapyBehavioural
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.
Vojta reflex locomotionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Motor Program Activating Therapy (MPAT) | Experimental | 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. Receives: Behavioral: Motor Program Activating Therapy |
| Vojta Reflex Locomotion (VRL) | Experimental | 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. Receives: Behavioral: Vojta reflex locomotion |
| healthy controls | No intervention | sex and age matched healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 0 month
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)
Measured: 0 and 2 months
Secondary outcomes (5)
Nine Hole Peg Test - NHPT
measure finger dexterity (quicker time means better function)
Measured: 2 months
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.
Measured: 2 months
Berg Balance Scale - BBS
14 items objective measure of static balance and risk of falls (0 the best, 56 the worse)
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study startMay 2015
- Primary completion15 May 2017
- Study completion10 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuronal PlasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study was designed as parallel group (outpatients) randomized comparison of two kinds of physiotherapeutic interventions referred to healthy controls.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamila Řasová, Charles University, Czech Republic
- Investigators
- Kamila Řasová, Ph.D., Principal investigator, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448444
- Sponsor's protocol ID
- EK-VP/22/0/2014/2
- Status last verified
- Jun 2020
- First submitted
- 18 Jun 2020
- Last updated
- 29 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Activity Changes Following Neuroproprioceptive Physiotherapy in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04448444
- Acronym / sponsor ID
- EK-VP/22/0/2014/2
- Conditions
- Neuronal Plasticity, Multiple Sclerosis, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- 15 May 2017 (actual)
- Study completion
- 10 Nov 2019 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The study was designed as parallel group (outpatients) randomized comparison of two kinds of physiotherapeutic interventions referred to healthy controls.
| Arm | Type | Receives |
|---|---|---|
| Motor Program Activating Therapy (MPAT) | Experimental | Behavioral: Motor Program Activating TherapyThe 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. |
| Vojta Reflex Locomotion (VRL) | Experimental | Behavioral: Vojta reflex locomotionVRL 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. |
| healthy controls | No intervention | –sex and age matched healthy controls |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor Program Activating TherapyPatients 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. | Behavioural | Motor Program Activating Therapy (MPAT) |
| Vojta reflex locomotionPatients 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. | Behavioural | Vojta Reflex Locomotion (VRL) |
Primary outcome
Brain activity
Time frame: 0 month
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
Time frame: 0 and 2 months
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)
5 secondary outcomes
Nine Hole Peg Test - NHPT
Time frame: 2 months
Paced Auditory Serial Addition Test - PASAT
Time frame: 2 months
Berg Balance Scale - BBS
Time frame: 2 months
Timed 25 Foot Walk - T25FW
Time frame: 2 months
Timed Up and Go - TUG
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamila Řasová, Ph.D. principal investigator
Charles University, Czech Republic
Questions about this trial
What is this clinical trial studying?
A study testing Motor Program Activating Therapy and Vojta reflex locomotion in people with Neuronal Plasticity and Multiple Sclerosis, run by Charles University, Czech Republic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activity (time frame: 0 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2020.