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

NCT04379193 | Completed

• 1 other identifier: VP/22/0/2014/1
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

neuroactive steroids; physical therapy; dehydroepiandrosterone; cortisol; multiple sclerosis

Outcome Measures

Primary Outcomes (1)

• serum level of neuroactive steroids

  cortisol, cortisone, 7 alfa-OH-DHEA, 7 beta-OH-DHEA, 7 oxo- oxo-DHEA, DHEA

  2 months

Secondary Outcomes (4)

• Berg Balance Scale, BBS outcomes

  2 months

• Paced Auditory Serial Addition Test

  2 months

• the 29-item Multiple Sclerosis Impact Scale, MSIS -29

  2 months

• Modified Fatigue Impact Scale

  2 months

Study Arms (2)

Motor program activating therapy

EXPERIMENTAL

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.

Behavioral: Neuroproprioceptive facilitation and inhibition physical therapy

Vojta's reflex locomotion

EXPERIMENTAL

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.

Behavioral: Neuroproprioceptive facilitation and inhibition physical therapy

Interventions

Neuroproprioceptive facilitation and inhibition physical therapy BEHAVIORAL

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

Motor program activating therapy; Vojta's reflex locomotion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• other neurological disease or conditions disabling movement

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Related Publications (1)

• 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.

  PMID: 33142850 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Kamila Řasová, Ph.D.

  Third Faculty of Mecicine, Charles Univerzity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assoc. prof. Kamila Řasová, Ph.D.

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 7, 2020
• Study Start: May 20, 2015
• Primary Completion: May 20, 2017
• Study Completion: September 1, 2019
• Last Updated: May 7, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share