Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This study will investigate if using commercially available active gaming technology, or in other words, virtual reality (VR) augmented exercise, can help people affected by multiple sclerosis (MS). Many people with MS have problems with physical function and activity due to balance and muscle problems, as well as pain. This can be a primary factor in the restriction of their activities and therefore has a negative influence on their quality of life. There has been very little research published into the effects of using VR augmented exercise as a rehabilitation tool, and to the knowledge of the researcher there are no published studies investigating the use of this technology for people with MS.

Who can participate?
Men and women aged 18-65 years with a clinical diagnosis of MS.

What does the study involve?
Participants will be randomly allocated to one of three groups:
1. Four weeks of twice-weekly 40-minute sessions of supervised one-to-one visual reality (VR) augmented exercise using the Nintendo Wii™ and Wii Fit™ system.
2. Four weeks of twice-weekly 40-minute sessions of supervised one-to-one 'traditional' physiotherapy prescribed gym-based exercise.
3. Four weeks of usual care.

What are the possible benefits and risks of participating?
Participants may experience improvements in terms of pain and function.

Where is the study run from?
Teesside University (UK).

When is the study starting and how long is it expected to run for?
The study ran from August 2011 to April 2012.

Who is funding the study?
Teesside University (UK).

Who is the main contact?
Mr Jonathan Robinson

Trial website

Contact information



Primary contact

Mr Jonathan Robinson


Contact details

Teesside University
Phoenix Building
United Kingdom
+44 (0)1642 738 313

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

An investigation of the use of virtual reality based augmented exercise for people with multiple sclerosis


Study hypothesis

The aims of the study are to investigate the effect of virtual augmented exercise on
1. The management of pain and function in multiple sclerosis (MS) as recorded through the MS walking scale, pain questionnaire and the World Health Organization Disability assessment Schedule II
2. Investigate the mechanisms underlying any effects through centre of pressure measures and physiological measures of electromyography (EMG)
3. Explore the usability and acceptance of the technology through questionnaires of usability and acceptance

Ethics approval

1. National Research Ethics Service Committee North East - Newcastle & North Tyneside 1, 21/06/2011, ref:11/NE/0151
2. Teesside University School of Health and Social Care Research Governance and Ethics Committee, 13/04/2011, ref: 097/11

Study design

Exploratory randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type

Quality of life

Patient information sheet

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


Multiple sclerosis


Participants will be randomly allocated to one of three groups:
1. Four weeks, twice weekly, 40 minute sessions of supervised one-to-one visual reality (VR) augmented exercise using the Nintendo Wii™ and Wii Fit™ system
2. Four weeks, twice weekly, 40 minute sessions of supervised one-to-one 'traditional' physiotherapy prescribed gym based exercise
3. Four weeks of usual care (Control)

Intervention type



Drug names

Primary outcome measures

1. Standing balance during quiet unipedal (standing on one foot) and bipedal (standing on two feet) stance recorded by Kistler™ force plate
2. Dynamic balance during sit-to-stand and ground reaction force
3. Temporal distance parameters of gait stride length, cadence, velocity, single and double limb support time
4. Measures of technology acceptance and exercise experience questionnaires

Secondary outcome measures

1. Muscle activity: relationships between electromyography (EMG) and measures of static and dynamic postural stability
2. Self reported walking ability: differences in MSWS12
3. Self reported function: differences in WHODAS II, and pain questionnaires
4. Self reported exertion: Rating of Perceived Exertion

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. Men and women
2. Aged 18-65 years
3. A clinical diagnosis of MS
4. Expanded Disability Status Scale (EDSS) score of one to six (Kurtzke, 1983)
5. Able to read and comprehend written and spoken English (regrettably validated translations of the outcome measure questionnaires are not available)

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Currently in acute exacerbation and/or has relapsed within the last three months
2. Diagnoses of any other condition affecting the central nervous system
3. Any musculoskeletal injury or condition for which a health professional has advised the person to refrain from undertaking moderate physical activity
4. Any doubt of ability to give informed consent
5. Currently receiving physical therapy aimed at improvements in fitness and balance
6. Any allergy to conductance gel and/or hypoallergenic tape used during electromyography

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Teesside University
United Kingdom

Sponsor information


Teesside University (UK)

Sponsor details

School of Health and Social Care
United Kingdom

Sponsor type




Funder type


Funder name

Teesside University (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in:

Publication citations

Additional files

Editorial Notes