Evaluating the effect of a simple cooling cap on functional performance in thermosensitive people with multiple sclerosis

Completed (inferred)Not a drug-phase studyMS (type not specified)ISRCTN56350227

What it found

No results found

We found no results in the registry or in papers.

This trial finished 5 years ago. We found no results in the registry or in any paper that cites it.

What it measured

Main measures

  • Measured after each experimental period: 1. Functional mobility measured using the timed 25 foot walk test 2. Functional mobility measured using the 2 minute walking test 3. Fine motoric function measured using the nine hole peg test

    Disability progressionWalking and mobility

Other measures (1)

  • Measured after each experimental period: 1. Cognitive function measured using the symbol digit modality test 2. Fatigue measured using the Fatigue Severity Scale

    Thinking and memoryFatigue

Who could take part

MS (type not specified)

Show the full criteria

Inclusion criteria

Inclusion: 1. Patients treated in MS centre of the Department of Neurology, First Faculty of Medicine Charles University and General University Hospital in Prague, who suffered from subjectively perceived thermosensitivity 2. Clinically stable MS (at least 60 days since the last attack) 3. Stable medication (no changes in treatment in last 90 days) 4. Without the presence of another serious disease (disease of musculoskeletal system, internal disease etc) 5. Without significant limitation of cognitive function Exclusion: 1. Any other condition that limit walking and fine motoric skills 2. Non thermosensitive patients

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

Background and study aims Multiple sclerosis (MS) is a condition that can affect the brain and spinal cord, causing a wide range of potential symptoms, including problems with vision, arm or leg movement, sensation or balance. Heat sensitivity is a common symptom in MS. Symptom deterioration usually appears after 8 minutes of heating, when the body temperature has increased by 0.8°C, and is reduced approximately after 15 minutes after heating is ended. Especially during the hot summer months, an increase in body temperature can cause difficulties in normal daily functioning in people with multiple sclerosis. In previous studies, different techniques and equipment have been used to provide cooling. Active cooling techniques (usually a vest or other liquid condition garment) achieve a greater effect than passive ones. The main limitations of these garments are the lack of transportability and large power source. Other options represent cooling techniques based on the principle of evaporation. In most cases, cooling the centre of the body, i.e. the torso area, is achieved with various types of vests. In clinical practice, we sometimes meet patients who have had a positive experience with simple cooling devices based on the principle of evaporation (manufactured, for example, for athletes or motorcyclists). The aim of this study was therefore to verify whether these simple and cheap cooling aids can really affect functional performance in thermosensitive people with MS. Who can participate? People with multiple sclerosis who are thermosensitive (they feel worsening of their symptoms during hot days). What does the study involve? It is necessary to visit the rehabilitation centre on 2 different days to receive a cooling cap and undergo functional assessment (walking tests, fine motoric skills and questionnaire). What are the possible benefits and risks of participating? The benefit of participating in the study is receiving a cooling cap. There are no risks associated with participation in the study. Where is the study run from? Department of Neurology First Faculty of Medicine and General University Hospital (Czechia) When is the study starting and how long is it expected to run for? September 2016 to December 2020 Who is funding the study? MS rehab z.s. (Czechia) Who is the main contact? Klara Novotna, klara.novotna@vfn.cz

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History

    1. Started

      Jun 2020

    2. Finished

      Dec 2020

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