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

CompletedNot a drug-phase studyMS (type not specified)NCT04533971

What it found

No results found

We found no results in the registry or in papers.

This trial finished 6 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Whole body cryotherapy

What it measured

Main measures

  • Assessment of changes in the level of fatigue

    On the day preceding the start of a 20 series of WBC ( 4 weeks) ( T0) and between the second and the fourth day, after the end of a series of WBC (T1).

    Fatigue
  • Assessment of changes in walking speed

    On the day preceding the start of a 20 series of WBC ( 4 weeks) ( T0) and between the second and the fourth day, after the end of a series of WBC (T1).

    Walking and mobility
  • Assessment of changes in hand grip strength

    On the day preceding the start of a 20 series of WBC ( 4 weeks) ( T0) and between the second and the fourth day, after the end of a series of WBC (T1).

    Arm and hand functionPhysical function
  • Assessment of changes in the bioelectrical activity of muscles.

    On the day preceding the start of a 20 series of WBC ( 4 weeks) ( T0) and between the second and the fourth day, after the end of a series of WBC (T1).

Who could take part

MS (type not specified) · 18 and over · EDSS 0 to 3

Show the full 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.

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Loading reviews and guidelines…

History

    1. Started

      Apr 2015

    2. Main results due

      Dec 2019

    3. Finished

      Dec 2019

    Assembled by software from public sources.