Physical Therapy and Neuroactive Steroids Therapy Does Not Modulate Serum Level of Neuroactive Steroids

NCT ID: NCT04379193

Last Updated: 2020-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-20
• Study Completion Date: 2019-09-01

Brief Summary

This study describes modulation of neuroproprioceptive facilitation and inhibition physical therapy on serum level of neuroactive steroids in multiple sclerosis.

Detailed Description

In the parallel group, single blind, randomized controlled trial, participant underwent two kinds of neuroproprioceptive PT (MPAT and VRL). At baseline and after the end of the two months' therapeutic program, a blinded assessor evaluated clinical outcomes and data from serum level.

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

Neuroproprioceptive facilitation and inhibition physical therapy

Intervention Type: BEHAVIORAL

All groups underwent two months' therapy, 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

Neuroproprioceptive facilitation and inhibition physical therapy

Intervention Type: BEHAVIORAL

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

Interventions

Neuroproprioceptive facilitation and inhibition physical therapy

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

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

Angelova G, Skodova T, Prokopiusova T, Markova M, Hruskova N, Prochazkova M, Pavlikova M, Spanhelova S, Stetkarova I, Bicikova M, Kolatorova L, Rasova K. Ambulatory Neuroproprioceptive Facilitation and Inhibition Physical Therapy Improves Clinical Outcomes in Multiple Sclerosis and Modulates Serum Level of Neuroactive Steroids: A Two-Arm Parallel-Group Exploratory Trial. Life (Basel). 2020 Oct 31;10(11):267. doi: 10.3390/life10110267.

Reference Type: DERIVED

PMID: 33142850 (View on PubMed)

Other Identifiers

VP/22/0/2014/1

Identifier Type: -

Identifier Source: org_study_id