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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04379193
• Other study ID #: VP/22/0/2014/1
• Status: Completed
• Phase: N/A
• Start date: May 20, 2015
• Est. completion date: September 1, 2019

Study information

• Verified date: May 2020
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: September 1, 2019
• Est. primary completion date: May 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum level of neuroactive steroids	cortisol, cortisone, 7 alfa-OH-DHEA, 7 beta-OH-DHEA, 7 oxo- oxo-DHEA, DHEA	2 months
Secondary	Berg Balance Scale, BBS outcomes	14 items objective measure of static balance and risk of falls (0 the best, 56 the worse)	2 months
Secondary	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
Secondary	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
Secondary	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