Condition category
Nervous System Diseases
Date applied
24/03/2014
Date assigned
04/04/2014
Last edited
11/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Multiple sclerosis (MS) is a long-term and disabling illness of the brain and spinal cord. Patients with MS often have problems with walking and an overwhelming tiredness. Therefore, activities of daily life are challenging and quality of life is poor. Physiotherapy has been found to be useful to improve walking, fatigue and quality of life in patients with MS. This is even more true for physiotherapy settings that are tailored to the individual patient's needs. In recent years, new physiotherapy strategies have been developed. Two of them are motor imagery and rhythmic auditory stimulation. Motor imagery means that somebody thinks about moving her or his body in a certain way. Motor imagery of walking has been shown in studies to improve walking. Motor imagery can be practised with verbal guiding and/or audible information. It has been found in studies that it is easier to concentrate on the motor imagery with this additional information. Further, motor imagery works best when patients 'feel' the movement they imagine. Rhythmic auditory stimulation means that while moving a person hears the rhythm made by music or a metronome, and that this person´s movement is influenced by the rhythm. Rhythmic auditory stimulation also has been shown to improve walking in patients with neurologic diseases. Only two studies were found to test the effects of rhythmic auditory stimulation in people with MS. These were only small studies showing that balance and fatigue got better. Several researchers compared the effect of music and metronome signals on walking. This was mostly done in patients with stroke and Parkinson´s disease. The studies' results showed a walking improvement, and motor imagery was more lively and precise with any audible signals. Therefore, it will be interesting if either music or metronome signals can support motor imagery in patients with MS. In this study, a combination of motor imagery and music or metronome signals will be used. This study seeks to find out the effect of rhythmic-cued motor imagery on walking (speed and distance), tiredness and quality of life in people with multiple sclerosis.

Who can participate?
Adult, German-speaking, MS patients at the participating clinic can take part.

What does the study involve?
You will be randomly allocated to one of three groups: A, B or C. Group A receives motor imagery with music and verbal guiding, plus weekly phone calls for support; group B receives motor imagery with metronome signals and verbal guiding, plus weekly phone calls for support; and group C receives usual treatment plus weekly phone calls asking about well-being. If you are in the treatment groups you will be informed beforehand. The treatment will take place at your home and it will last 4 weeks. You will be asked to sit down, close your eyes and imagine that you are walking at various speeds, according to the CD. You are asked to do this six times a week for 17 minutes. The Audio Mix on the CDs will be changed every week. Walking will be assessed using two walking tests. You will be asked to fill in five questionnaires about walking, fatigue and quality of life. Assessments will be taken at the start and after 4 weeks. Refreshments will be provided during testing.

What are the possible benefits and risks of participating?
You will not be at risk of falling or exhaustion during the home-based motor imagery, therefore the treatment is considered to be safe. The walking tests will be done in a hallway close to the wall and you will be safeguarded by the researcher. You will be allowed to rest during the assessments if you wish to. You might benefit from the intervention if you are in the treatment group with better walking and feeling less fatigued; however, this cannot be guaranteed. No side effects are expected as result of this treatment.

Where is the study run from?
MS Clinics, Innsbruck Medical University, Department of Neurology, Austria.

When is the study starting and how long is it expected to run for?
The study starts in March 2014. Participants will be enrolled on the study for a period of two and a half years (September 2016); however, the study will extend beyond this if necessary, up to 42 months (September 2017).

Who is funding the study?
Multiple Sclerosis Society of Austria (Austria)

Who is the main contact?
Mrs Barbara Seebacher
b.seebacher@aon.at

Trial website

Contact information

Type

Scientific

Primary contact

Prof Thomas Berger

ORCID ID

Contact details

Innsbruck Medical University
Department of Neurology
Anichstrasse 35
Innsbruck
6020
Austria
+43 (0)512 504 26277
thomas.berger@i-med.ac.at

Type

Scientific

Additional contact

Mrs Barbara Seebacher

ORCID ID

Contact details

Physiotherapie Bürgerhof
Schwarzseestraße 14/20
Kitzbühel
AT-6370
Austria
-
b.seebacher@aon.at

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of rhythmic cued motor imagery on walking, fatigue and quality of life in people with multiple sclerosis: a randomised controlled single-centre trial

Acronym

Study hypothesis

H01: A rhythmic cued motor imagery will not change walking distance and walking speed in people with multiple sclerosis (MS)
H02: A rhythmic cued motor imagery will not change fatigue in people with MS
H03: A rhythmic cued motor imagery will not change (health-related) quality of life in people with MS

Ethics approval

1. University of Brighton, Faculty of Health and Social Science, Faculty Research Ethics Governance Committee, 09/01/2014, ref: 13 053.
2. Ethics Committee of Innsbruck Medical University, 02/04/2014, ref: AN2014-0052 334/4.14

Study design

Randomised controlled single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Multiple sclerosis

Intervention

Pilot study: participants will be randomly allocated to one of three groups (below)
Main study: there will be a specific allocation to groups (stratified block randomisation)

Group A: guided motor imagery plus rhythm from music, weekly phone calls for support. Sitting position, eyes closed, first-person perspective, 6 times a week, 17 minutes, 4 weeks; weekly change of Audio-Mix provided by a CD designed for this study. Detailed instructions.

Group B: guided motor imagery plus metronome cues, weekly phone calls for support. Same procedure.

Group C: controls. Normal treatment, weekly phone calls, asking about well-being.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Change in walking measured by the Timed 25-Foot Walk (T25FW) and 6-Minute Walk Test (6MWT). Assessments will be taken at the start and after 4 weeks.

Secondary outcome measures

Change of:
1. Walking (MS Walking Scale-12, MSWS-12)
2. Fatigue (Modified Fatigue Impact Scale, MFIS)
3. Quality of life (MS Impact Scale-29, MSIS-29)
4. Health-related quality of life (Short-Form Health Survey-36, SF-36, EQ-5D-3L)
Assessments will be taken at the start and after 4 weeks.

Overall trial start date

31/03/2014

Overall trial end date

19/02/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. People with mild MS (Expanded Disability Status Scale, EDSS 1.5 to 4.5)
2. Aged 18 years or over
3. Clinical MS according to McDonald's criteria as diagnosed by Innsbruck MS Clinics
4. All MS phenotypes
5. Any ethnicity
6. German speaking

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

1. Concomitant other diseases which are affecting rhythmic cued motor imagery and walking (e.g., hearing impairment)
2. A relapse of MS within the last 3 months
3. Known pregnancy
4. Any cognitive deficits or depression, diagnosed and documented by the MS Clinics in Innsbruck
5. A relapse during the intervention period will lead to exclusion of the participant

Recruitment start date

09/04/2014

Recruitment end date

28/02/2015

Locations

Countries of recruitment

Austria

Trial participating centre

Innsbruck Medical University
Innsbruck
6020
Austria

Sponsor information

Organisation

Innsbruck Medical University (Austria)

Sponsor details

c/o Professor Thomas Berger
Clinical Department for Neurology
Anichstrasse 35
Innsbruck
6370
Austria
+43 (0)512 504 26277
thomas.berger@i-med.ac.at

Sponsor type

University/education

Website

https://www.i-med.ac.at/mypoint/

Funders

Funder type

Charity

Funder name

Multiple Sclerosis Society of Austria (Austria)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 results in: http://www.pilotfeasibilitystudies.com/content/1/1/25
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27055804

Publication citations

  1. Results

    B Seebacher, R Kuisma, A Glynn, T Berger, Rhythmic cued motor imagery and walking in people with multiple sclerosis: a randomised controlled feasibility study, Pilot and Feasibility Studies, 2015, 1, 25, doi: 10.1186/s40814-015-0021-3.

  2. Results

    Seebacher B, Kuisma R, Glynn A, Berger T, The effect of rhythmic-cued motor imagery on walking, fatigue and quality of life in people with multiple sclerosis: A randomised controlled trial, Mult Scler, 2016, doi: 10.1177/1352458516644058.

Additional files

Editorial Notes

11/04/2016: Publication reference added.