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

Not Applicable

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT04379193
• Lead Sponsor: Charles University, Czech Republic

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.

Study Timeline

• Study Start: 2015-05-20
• Primary Completion: 2017-05-20
• Study Completion: 2019-09-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-05
• Last Update Submitted: 2020-05-05
• Study First Posted: 2020-05-07
• Last Update Posted: 2020-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
serum level of neuroactive steroids	2 months	cortisol, cortisone, 7 alfa-OH-DHEA, 7 beta-OH-DHEA, 7 oxo- oxo-DHEA, DHEA

Secondary Outcome Measures

Name	Time	Method
Berg Balance Scale, BBS outcomes	2 months	14 items objective measure of static balance and risk of falls (0 the best, 56 the worse)
Paced Auditory Serial Addition Test	2 months	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.
the 29-item Multiple Sclerosis Impact Scale, MSIS -29	2 months	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).
Modified Fatigue Impact Scale	2 months	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.