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Completed

NCT Number: NCT04379193

Physical Therapy and Neuroactive Steroids 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. serum level of neuroactive steroids

    Time frame: 2 months

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

Secondary outcomes

  1. Berg Balance Scale, BBS outcomes

    Time frame: 2 months

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

  2. Paced Auditory Serial Addition Test

    Time frame: 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.

  3. the 29-item Multiple Sclerosis Impact Scale, MSIS -29

    Time frame: 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).

  4. Modified Fatigue Impact Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2019
First posted
May 7, 2020
Registry last updated
May 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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