The effect of balance training on balance in people with multiple sclerosis using a virtual reality system
| ISRCTN | ISRCTN14425615 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14425615 |
| Secondary identifying numbers | 001 |
- Submission date
- 20/01/2016
- Registration date
- 21/01/2016
- Last edited
- 09/08/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Multiple sclerosis (MS) is one of the most common diseases of the central nervous system (brain and spinal cord). Healthy nerves are coated in a fatty casing (myelin sheath) which helps messages to travel quickly and smoothly along nerves. When a person is suffering from MS, the immune system, which normally helps to protect against infection, attacks the myelin sheath, stripping it from the nerves (demyelination). This demyelination means that messages cannot travel along the nerves effectively, causing a range of disabilities. Around 85% of MS sufferers are diagnosed with the relapsing remitting type. This is where the sufferer has sudden flare-ups of symptoms (relapses) followed by periods where the symptoms are very mild or disappear completely. Many people suffering from MS suffer from problems with balance. The aim of this study is to look at the effects of training with a new virtual reality system on balance in people with MS and compare it with traditional physical therapy.
Who can participate?
Adults aged between 25 and 55 who have been diagnosed with relapsing-remitting MS and are moderately disabled.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group complete a 6 week virtual reality training program. The participants take part in two sessions a week which include around 30 minutes of balance training. Participants are asked to stand of a moving platform and look at a screen with a road on it. The road itself includes flat, bumpy and tilting sections and the moving platform moves in sync with the image of the road on the screen (i.e. when the road tilts, the platform tilts). Participants are asked to “walk” along the road whilst keeping their balance. Participants in the second group take part in a conventional exercise program (traditional physical therapy), which consists of balancing on an uneven surface (foam), an unstable base (wobble board) and by catching balls thrown at them from different directions but stepping forward or sideways. At the study of the study and then again at the end of the 6 week training programs, participants in both groups complete a number of assessments and questionnaires in order to find out if their balance has improved.
What are the possible benefits and risks of participating?
Participants may benefit from improved balance as a result of taking part in the study. There are no significant risks of taking part, however some participants may experience nausea because of the moving platform used.
Where is the study run from?
Sheba Medical Center (Israel)
When is the study starting and how long is it expected to run for?
June 2013 to June 2015
Who is funding the study?
National Multiple Sclerosis Society (USA)
Who is the main contact?
Dr Alon Kalron
alkalron@gmail.com
Contact information
Scientific
Multiple Sclerosis Center, Sheba Medical Center
Sheba road 2
Tel-HaShomer
Ramat-Gan
46379
Israel
| Phone | +972 (0)3 5305284 |
|---|---|
| MS@Sheba.Health.gov.il |
Study information
| Study design | Pilot randomised parallel trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | The effect of balance training on postural control in people with multiple sclerosis using the CAREN virtual reality system: a pilot randomized controlled trial |
| Study hypothesis | Following the intervention period, both groups will demonstrate improved balance capabilities, although greater improvements are expected in the virtual reality (VR) training group. |
| Ethics approval(s) | Sheba Medical Center Independent Ethics Committee, ref: 046613SMC |
| Condition | Multiple sclerosis |
| Intervention | Participants are randomly allocated to one of two groups. Virtual reality (VR) group: Patients participate in 12 sessions of CAREN VR over six weeks, with a total of 30 minutes of balance training during each session. Rest breaks are allowed if requested, but are not included in the overall practice time. Typically, the participants take three rest breaks during each practice session, each lasting approximately 3-4 minutes. The training session lasts 45-50 minutes. Participants are instructed to continue their regular physical activities between intervention sessions. The VR system used is the CAREN Integrated Reality System with D-flow software, which works in real-time, enabling the creation of a variety of controlled and repeated simulated environments via dedicated software which includes 3D visual, sound, and proprioceptive stimuli. The following components are incorporated in the system: 1. Motion Platform: CAREN consists of an electro-hydraulic 2m diameter motion platform (Rexroth Hydraudyne, MOTEK, Micro motion) that can be manipulated by 6 degrees of freedom. The movement of the platform is either driven by the subject's movements or pre-programmed in synchrony with function curves that define a specific pathway in the virtual environment. 2. Projection: The virtual scene is projected on a large screen (3m × 2.5m). For the study, a 'road scene' is used which requires subjects to stand on a motion platform while maintaining their balance and advancing along a pre-defined road. The road itself has flat, straight and vertical bumpy sections, right and left tilts and right and left translations. The platform's movement is correlated with the visual stimulus (i.e. when the subject arrives at a bump on the screen, the platform elevates. When the road tilts, the platform tilts accordingly in the same direction). The VR training also includes a secondary task which involves intercepting 18 moving targets (a colored ball of 12.5 cm diameter) appearing above the road. Each target can be intercepted when appearing no further than 20cm from the subject's hands (which are reflected on the screen as a 4.5cm in diameter ball). Conventional exercise group: Patients participate in 12 sessions of conventional exercise training. In each of the 12 sessions, the participants undergo 10 minutes of stretching exercises and 20 minutes of exercise. In general, the training protocol encompasses 3 dimensions: 1. Static stance: Patients are encouraged to stand on pieces of foam (4 cm thick) with their eyes open or closed for approximately 60 seconds (depending upon the patient’s ability). The difficulty is increased by adding more foam pieces and reducing the support base (shoulder width/partial tandem/tandem). 2. Dynamic weight shifting: A physical therapist throws a ball in numerous directions. The patients have to catch the ball by stepping forward either laterally or squatting for approximately 30 times, depending upon the patient’s tolerance. 3. External perturbations: Patients are encouraged to stand on an unstable base (i.e. a wobble board) while the physical therapist deliberately pushes the top of the board in downward direction, at different places and speeds. For both groups, during all sessions, the patient is supervised by the physical therapist in order to prevent falls. |
| Intervention type | Other |
| Primary outcome measure | Center of pressure (CoP) trajectories are measuring using posturography measurements taken from the Zebris FDM-T Treadmill data at baseline and 6 weeks. |
| Secondary outcome measures | 1. Stability is measured using the Functional Reach Test (FRT) at baseline and 6 weeks 2. Balance is measured using the Berg Balance Test (BBS) at baseline and 6 weeks 3. Ability to change directions while stepping is measured using the Four Square Step Test (FSST) at baseline and 6 weeks 4. Fear of falling is measured using the Falls Efficacy Scale International (FES-I) at baseline and 6 weeks |
| Overall study start date | 01/06/2013 |
| Overall study end date | 01/06/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 |
| Participant inclusion criteria | 1. Diagnosis of definite relapsing-remitting MS according to the revised McDonald criteria 2010 2. Aged between 25 and 55 years 3. Moderate neurological disability as scored by the expanded disability status scale (EDSS), ranging from 3.0 to 6.0 inclusive with a pyramidal functional score of at least 3 |
| Participant exclusion criteria | 1. MS clinical relapse or treatment with corticosteroid therapy within 6-months prior to examination 2. Patients experiencing major depression or cognitive decline 3. Orthopedic disorders that could negatively affect balance 4. Pregnancy 5. Blurred vision 6. Cardiovascular disorders |
| Recruitment start date | 01/06/2014 |
| Recruitment end date | 01/03/2015 |
Locations
Countries of recruitment
- Israel
Study participating centre
Sheba road 2
Ramat-Gan
5262100
Israel
Sponsor information
Hospital/treatment centre
Sheba road 2
Ramat-Gan
5262100
Israel
| Phone | +972 (0)3 5303030 |
|---|---|
| MS@Sheba.health.gov.il | |
"ROR" |
https://ror.org/020rzx487 |
Funders
Funder type
Charity
Government organisation / Associations and societies (private and public)
- Alternative name(s)
- National MS Society, The National Multiple Sclerosis Society, The National MS Society, National Multiple Sclerosis Society, Inc., Sociedad Nacional de Esclerosis, Sociedad Nacional de Esclerosis Múltiple, NMSS
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/06/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of results in a peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2016 | Yes | No |
Editorial Notes
09/08/2016: Publication reference added.
