Brain Activity Changes Following Neuroproprioceptive Physiotherapy in Multiple Sclerosis

NCT04448444 | Completed DMC

• 1 other identifier: EK-VP/22/0/2014/2
• Study Type: interventional
• Target: 87
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neuronal Plasticity; Multiple Sclerosis; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  0 and 2 months

Secondary Outcomes (5)

• Nine Hole Peg Test - NHPT

  2 months

• Paced Auditory Serial Addition Test - PASAT

  2 months

• Berg Balance Scale - BBS

  2 months

• Timed 25 Foot Walk - T25FW

  2 months

• Timed Up and Go - TUG

  2 months

Study Arms (3)

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.

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.

Behavioral: Vojta reflex locomotion

healthy controls

NO INTERVENTION

sex and age matched healthy controls

Interventions

Motor Program Activating Therapy 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.

Motor Program Activating Therapy (MPAT)

Vojta reflex locomotion 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.

Vojta Reflex Locomotion (VRL)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Kamila Řasová, Ph.D.

  Charles University, Czech Republic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc. prof. Kamila Řasová, Ph.D.

Model Details: The study was designed as parallel group (outpatients) randomized comparison of two kinds of physiotherapeutic interventions referred to healthy controls.

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 25, 2020
• Study Start: May 1, 2015
• Primary Completion: May 15, 2017
• Study Completion: November 10, 2019
• Last Updated: June 29, 2020

Record last verified: 2020-06