Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Video game therapy, Balance, Cognitive functions, Dual tasking
Brief summary
Multiple Sclerosis (MS) is often characterized by the presence of balance and cognitive impairments. Cognitive functions play a key role in balance control. Simultaneously performing cognitive tasks decreases walking and balance ability (Dual-Task cost). Rehabilitative treatment of patients with MS does not have to consider separately the motor and cognitive aspects. Video-Game Therapy (VGT) is a novel tool that allows a multimodal training approach. VGT typically provides augmented feedback during training that can contribute to learning motor skills. The main objective of this exploratory study will be to test the effects of a commercially available VGT on balance and cognitive function in ambulatory MS patients compared to a standardized balance platform training (BPT). Secondary, we will explore the effects of VGT and BPT on other domains that are usually impaired in MS population and that can be improved by motor rehabilitation, such as psychological well-being, fatigue and Quality of Life.
Interventions
DEVICEVideo game therapy
Video game therapy will be delivered with a commercial video game console (X-Box 360 Kinect, Microsoft, Inc., Redmond, WA).
DEVICEBalance platform therapy
Balance/rebalancing, postural stability and weight-shifting exercises with and without visual feedback will be administered using a balance platform (Biodex Medical Systems, Inc., Shirley, NY).
Sponsors
University Hospital of Ferrara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* diagnosis of MS (primary or secondary progressive, relapsing-remitting), without relapses in the preceding 3 months * mild to moderate balance impairments with increased fall risk, defined as TUG \> 8.4s * disability rate definited by Kurtzke Expanded Disability Status Scale (EDSS) score from 4 to 5.5,
Exclusion criteria
* other conditions that may affect motor function * impaired cognitive functioning (Mini Mental Status Examination score less than 24) * visual impairments (daltonism and visual acuity deficit) * medical conditions that might interfere with the ability to complete the study protocol safely. A group of healthy subjects matched for age and sex will be involved for a comparison on the instrumental data (force platforms).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go (TUG) test | Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up | TUG measures balance and functional mobility. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Reach Test (FRT) | Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up | The FRT assesses the subject's stability by measuring the maximum distance an individual can reach forward while standing in a fixed position. |
| Dynamic Gait Index (DGI) | Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up | Clinical tool to assess gait, balance and risk of fall. |
| Modified Fatigue Impact Scale (MFIS) | Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up | Questionnaire which evaluates the perceived impact of fatigue on the subscales physical, cognitive and psychosocial functioning. |
| Multiple Sclerosis Walking Scale-12 (MSWS-12) | Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up | This questionnaire assesses the impact of MS on walking ability. |
| Multiple Sclerosis Impact Scale-29 (MSIS-29) | Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up | This is an health-rated quality of life questionnaire that assesses the impact of MS on physical and psychological functions. |
| Beck Depression Inventory-Second Edition (BDI-II) | Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up | This is a 21-item self-report instrument that serves to assess depression severity |
| Four Square Step Test (FSST) | Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up | The FSST is a timed test, intended to challenge the rapid change in direction while stepping forward, backward and sideways over a low obstacle. |
| Go-No Go - Test of Attentional Performance T.A.P. | Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up | Go-No Go task examine the specific capacity to suppress an inadequate reaction. |
| Test of Attentional Performance T.A.P. | Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up | In this task divided attention can be explored with computerized dual-task test where two stimuli (visual and acoustic) are required simultaneously |
| Stroop Color-Word Test (SCWT) | Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up | The SCWT explores sustained attention and some aspects of executive function. |
| Symbol Digit Modalities Test (SDMT) | Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up | The SDMT consists of orally substituting a number for a pseudorandom sequence of geometric figures as quickly as possible for testing executive functions. |
| Instrumented Basic Balance Evaluation (IBBE) | Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up | Force platform measurement are used as objective markers of subjects' balance ability. |
| Instrumented Dual Task (IDT) | Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up | Dual cognitive-motor tasks are often used in clinical practice to evaluate the interaction between patients' cognitive and motor ability . |
| State Trait Anxiety Inventory (STAI-Y) | Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up | STAI-Y is an easy-to-use and interpretative tool to detect and measure anxiety. |
Countries
Italy
Outcome results
None listed