The Effect of a Series of Systemic Cryotherapy Treatments on the Functional State of Patients With Multiple Sclerosis

P

Pomeranian Medical University Szczecin

Status

Completed

Conditions

Surface Electromyography
Whole-body Cryotherapy
Multiple Sclerosis (ICD10-G35)

Treatments

Other: Whole body cryotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04533971
2016.01.01

Details and patient eligibility

About

Multiple sclerosis (Latin: Sclerosis multiplex; MS) is a chronic, inflammatory and degenerative disease of the central nervous system (CNS) characterised by a varied course and symptomatology. The chronic nature of the disease and gradual loss of tissue within the CNS result in increasing neurological deficits and motor failure over time. Due to the characteristics of the symptoms and the chronic course of MS, patients with MS use various forms of physiotherapeutic procedures throughout most of their lives, including especially often whole-body cryotherapy (WBC) treatments. The aim of this study was to assess potential changes in bioelectrical muscle activity during rest and contraction after exposure on 20 series of Whole body cryotherapy (WBC) in patients with multiple sclerosis (MS). Assessment potential relationships between the sEMG parameters and functional state in patients with multiple sclerosis pre and post 20 series of WBC. Finally, 114 patients with MS participated in the planned procedures of research. The participants were randomly assigned to the two groups, WBC and control. The sample size was 60 in WBC, and 54 in control groups. Testing before and after series of WBC consisted of: clinical assessment of fatigue was performed by the Fatigue Severity Scale (FSS), gait speed using Timed 25 Foot Walk (T25-FW), Hand grip strength (HGS), and surface electromyography (sEMG) of the dominant hand.

Enrollment

114 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • documented diagnosis of MS,
  • functional status classified according to the Expanded Disability Status Scale (EDSS) to a level lower or equal to 0-3
  • no contraindications for WBC treatments found in the medical examination
  • no other serious chronic diseases identified that may affect the results of the tests carried out
  • readiness to participate in daily WBC
  • a written statement of volunteers about not using WBC treatments in the last 2 years, and not using other forms of physiotherapeutic and complementary therapies (other than planned in the procedures) for the period of this study.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

114 participants in 2 patient groups

WBC group
Experimental group
Description:
Criteria documented diagnosis of MS, functional status classified according to the Expanded Disability Status Scale (EDSS) to a level lower or equal to 0-3 no contraindications for WBC treatments found in the medical examination no other serious chronic diseases identified that may affect the results of the tests carried out readiness to participate in daily WBC a written statement of volunteers about not using WBC treatments in the last 2 years, and not using other forms of physiotherapeutic and complementary therapies (other than planned in the procedures) for the period of this study
Treatment:
Other: Whole body cryotherapy
Control Group
No Intervention group
Description:
Criteria documented diagnosis of MS, functional status classified according to the Expanded Disability Status Scale (EDSS) to a level lower or equal to 0-3 no contraindications for WBC treatments found in the medical examination no other serious chronic diseases identified that may affect the results of the tests carried out readiness to participate in daily WBC a written statement of volunteers about not using WBC treatments in the last 2 years, and not using other forms of physiotherapeutic and complementary therapies (other than planned in the procedures) for the period of this study

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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