Neuroproprioceptive "Facilitation, Inhibition" and Brain Plasticity (NEFAI)

Charles University, Czech Republic

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Functional electric stimulation; Behavioral: Motor program activating therapy; Behavioral: Vojta's reflex locomotion

Study type: Interventional

Funder types: Other

Identifiers

NCT04355663

VP/22/0/2014

Details and patient eligibility

About

This study investigates whether neuroproprioceptive "facilitation, inhibition" physical therapy induces plastic and adaptive processes of the CNS (white matter integrity changes), if they relate to clinical improvement, and whether therapeutic effect differs between different kinds of therapies.

Full description

In the Multi-Arm Parallel-Group Exploratory Trial, patients with multiple sclerosis were divided into three groups by an independent study coordinator, and underwent three kinds of neuroproprioceptive "facilitation, inhibition" physical therapy. At baseline and after the end of the two months' therapeutic program, a blinded assessor evaluated clinical outcomes and data from DTI .

Enrollment: 92 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• prevailed spastic paraparesis, stable clinical status and treatment in the preceding 3 months determined by neurologist,
• Expanded Disability Status Scale score (EDSS) max. 7.5

Exclusion criteria

• other neurological disease or conditions disabling movement

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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92 participants in 3 patient groups

Motor program activating therapy

Experimental group

Description:

MPAT is method developed and verified by our team. In this therapy, patients are corrected into a postural position where the joints are functionally centered. Somatosensory (manual and verbal) stimuli are then applied to activate motor programs in the brain, which then lead to the co-contraction of the patient's whole body when laying, sitting, standing up or moving forward. Activated programs are repeated under various conditions and in different situations and environments to teach the patients to automatically use the acquired motor skills in daily life. Therapy was realized within the ambulatory area of the Department of Neurology at Kralovske Vinohrady University Hospital in Prague.

Treatment:

Behavioral: Motor program activating therapy

Vojta's reflex locomotion

Experimental group

Description:

VRL is a standard approach for patients with MS in the Czech Republic. In the therapy, global patterns of the reflex locomotion are activated by stimulation of specific zones, with the individual placed in a precisely determined initial position (supine, prone and side laying, low kneeling position). These movement patterns have the qualities of the forward movement (locomotion) and the movement responses are precisely defined. Reflex locomotion (reflex turning and reflex creeping) is used in therapy to activate involuntarily responses of muscle function, which are necessary for spontaneous movements. Therapy was realized at the Department of Rehabilitation and Sport Medicine at Motol University Hospital.

Treatment:

Behavioral: Vojta's reflex locomotion

Functional electric stimulation

Experimental group

Description:

Functional electric stimulation in the postural corrected position was developed at our workplace. Participants first underwent individual two-hour session consisting of postural correction using MPAT and the device (The WalkAide® System, Innovative Neurotronics Inc., 4999 Aircenter Circle, Suite 103 Reno, NV 89502, USA) programming (28). Patients received the device to use as much as they felt they were able to during their normal daily living activities thereafter.

Treatment:

Behavioral: Functional electric stimulation