Condition category
Nervous System Diseases
Date applied
10/01/2012
Date assigned
01/03/2012
Last edited
15/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
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
J.Robinson@tees.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mr Jonathan Robinson

ORCID ID

Contact details

Teesside University
Phoenix Building
Middlesbrough
Cleveland
TS1 3BA
United Kingdom
+44 (0)1642 738 313
J.Robinson@tees.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

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

Condition

Multiple sclerosis

Intervention

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

Behavioural

Phase

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

01/08/2011

Overall trial end date

01/04/2012

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

66

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

01/08/2011

Recruitment end date

01/04/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Teesside University
Cleveland
TS1 3BA
United Kingdom

Sponsor information

Organisation

Teesside University (UK)

Sponsor details

School of Health and Social Care
Middlesbrough
Cleveland
TS1 3BA
United Kingdom
-
J.robinson@tees.ac.uk

Sponsor type

University/education

Website

http://www.tees.ac.uk

Funders

Funder type

University/education

Funder name

Teesside University (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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: http://www.ncbi.nlm.nih.gov/pubmed/25969739

Publication citations

Additional files

Editorial Notes