Brain Activity Changes Following Neuroproprioceptive Physiotherapy in Multiple Sclerosis

Not Applicable

Completed

• Conditions: Neuronal Plasticity; Multiple Sclerosis; Rehabilitation

• Registration Number: NCT04448444
• Lead Sponsor: Charles University, Czech Republic

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.

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2017-05-15
• Study Completion: 2019-11-10
• Status Verified: 2020-06
• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-06-24
• Study First Posted: 2020-06-25
• Last Update Submitted: 2020-06-25
• Last Update Posted: 2020-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Brain activity	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 Outcome Measures

Name	Time	Method
Paced Auditory Serial Addition Test - PASAT	2 months	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	2 months	14 items objective measure of static balance and risk of falls (0 the best, 56 the worse)
Timed 25 Foot Walk - T25FW	2 months	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	2 months	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.
Nine Hole Peg Test - NHPT	2 months	measure finger dexterity (quicker time means better function)