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

Ambulatory Neuroproprioceptive Facilitation and Inhibition Physical Therapy Does Not Modulate Serum Level of Neuroactive Steroids

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

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Neuroproprioceptive facilitation and inhibition physical therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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).
Experimental: 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.	Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum level of neuroactive steroids	cortisol, cortisone, 7 alfa-OH-DHEA, 7 beta-OH-DHEA, 7 oxo- oxo-DHEA, DHEA	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the 29-item Multiple Sclerosis Impact Scale, MSIS -29	a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5"extremely". Each of the two scales are scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates greater impact of disease on daily function (worse health).	2 months
Berg Balance Scale, BBS outcomes	14 items objective measure of static balance and risk of falls (0 the best, 56 the worse)	2 months
Paced Auditory Serial Addition Test	The PASAT is presented using audio cassette tape or compact disk 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.	2 months
Modified Fatigue Impact Scale	The MFIS is generally presented as a 21-item questionnaire, but there's also a 5-question version. Most people fill it out on their own in a doctor's office. Expect to spend anywhere from five to ten minutes circling your answers.	2 months

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2015
• Primary Completion (Actual): May 20, 2017
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: May 5, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 5, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: multiple sclerosis; physical therapy; cortisol; dehydroepiandrosterone; neuroactive steroids
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: VP/22/0/2014/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No