Brain Activity Changes Following Neuroproprioceptive Physiotherapy in Multiple Sclerosis

NCT ID: NCT04448444

Last Updated: 2020-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2019-11-10

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.

Conditions

Neuronal Plasticity; Multiple Sclerosis; Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Motor Program Activating Therapy (MPAT)

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.

Group Type: EXPERIMENTAL

Motor Program Activating Therapy

Intervention Type: BEHAVIORAL

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 Locomotion (VRL)

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.

Group Type: EXPERIMENTAL

Vojta reflex locomotion

Intervention Type: BEHAVIORAL

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.

healthy controls

sex and age matched healthy controls

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Motor Program Activating Therapy

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

Vojta reflex locomotion

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Charles University, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Kamila Řasová

assoc. prof. Kamila Řasová, Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kamila Řasová, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Third Faculty of Medicine Charles University

Other Identifiers

EK-VP/22/0/2014/2

Identifier Type: -

Identifier Source: org_study_id