Brain Activity Changes Following Neuroproprioceptive Physiotherapy in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Brain Activity Changes Following Neuroproprioceptive Physiotherapy in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04448444
• Other study ID #: EK-VP/22/0/2014/2
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: November 10, 2019

Study information

• Verified date: June 2020
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). The study determined whether facilitation physiotherapy could enhance brain plasticity, compared two facilitation methods, and looked for any relation to clinical improvement in pwMS.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: November 10, 2019
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Neuronal Plasticity
• Rehabilitation
• Sclerosis

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Nine Hole Peg Test - NHPT	measure finger dexterity (quicker time means better function)	2 months
Secondary	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.	2 months
Secondary	Berg Balance Scale - BBS	14 items objective measure of static balance and risk of falls (0 the best, 56 the worse)	2 months
Secondary	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.	2 months
Secondary	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.	2 months