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

Charles University, Czech Republic63 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Multiple Sclerosis

Interventions

Neuroproprioceptive facilitation and inhibition physical therapyBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

serum level of neuroactive steroids

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

Time frame: 2 months

Secondary Outcomes

Berg Balance Scale, BBS outcomes

14 items objective measure of static balance and risk of falls (0 the best, 56 the worse)

Time frame: 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.

Time frame: 2 months

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).

Time frame: 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.

Time frame: 2 months

Data from ClinicalTrials.gov

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