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Clinical Trials/NCT04448444
NCT04448444
Completed
N/A

Brain Activity Changes Following Neuroproprioceptive Physiotherapy in Multiple Sclerosis

Charles University, Czech Republic0 sites87 target enrollmentMay 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Neuronal Plasticity
Sponsor
Charles University, Czech Republic
Enrollment
87
Primary Endpoint
Brain activity
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
November 10, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Charles University, Czech Republic
Responsible Party
Principal Investigator
Principal Investigator

Kamila Řasová

assoc. prof. Kamila Řasová, Ph.D.

Charles University, Czech Republic

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • 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)
  • Nine Hole Peg Test - NHPT(2 months)

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