Neuroproprioceptive "Facilitation, Inhibition" and Brain Plasticity

NCT ID: NCT04355663

Last Updated: 2020-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-20
• Study Completion Date: 2019-08-01

Brief Summary

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.

Detailed 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 .

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Motor program activating therapy

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.

Group Type: EXPERIMENTAL

Motor program activating therapy

Intervention Type: BEHAVIORAL

Pacients underwent two months' therapy consisted of 16 face-to-face sessions (1 hour, twice a week for two months).

Vojta's reflex locomotion

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.

Group Type: EXPERIMENTAL

Vojta's reflex locomotion

Intervention Type: BEHAVIORAL

Pacients underwent two months' therapy consisted of 16 face-to-face sessions (1 hour, twice a week for two months).

Functional electric stimulation

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.

Group Type: EXPERIMENTAL

Functional electric stimulation

Intervention Type: BEHAVIORAL

Pacients uderwent two months' therapy. They used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions of Motor program activating therapy.

Interventions

Motor program activating therapy

Pacients underwent two months' therapy consisted of 16 face-to-face sessions (1 hour, twice a week for two months).

Intervention Type: BEHAVIORAL

Vojta's reflex locomotion

Pacients underwent two months' therapy consisted of 16 face-to-face sessions (1 hour, twice a week for two months).

Intervention Type: BEHAVIORAL

Functional electric stimulation

Pacients uderwent two months' therapy. They used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions of Motor program activating therapy.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charles University, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Kamila Řasová

assoc. prof. Kamila Řasová, Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kamila Řasová, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Third Faculty of Mecicine, Charles Univerzity

References

Rasova K, Buckova B, Prokopiusova T, Prochazkova M, Angel G, Markova M, Hruskova N, Stetkarova I, Spanhelova S, Mares J, Tintera J, Zach P, Musil V, Hlinka J. A Three-Arm Parallel-group Exploratory Trial documents balance improvement without much evidence of white matter integrity changes in people with multiple sclerosis following two months ambulatory neuroproprioceptive "facilitation and inhibition" physical therapy. Eur J Phys Rehabil Med. 2021 Dec;57(6):889-899. doi: 10.23736/S1973-9087.21.06701-0. Epub 2021 Feb 10.

Reference Type: DERIVED

PMID: 33565742 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

VP/22/0/2014

Identifier Type: -

Identifier Source: org_study_id