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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
48
Video game therapy will be delivered with a commercial video game console (X-Box 360 Kinect, Microsoft, Inc., Redmond, WA).
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).
Sofia Straudi
Ferrara, Emilia-Romagna, Italy
Ferrara University Hospital
Ferrara, Italy
Timed Up and Go (TUG) test
TUG measures balance and functional mobility.
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Four Square Step Test (FSST)
The FSST is a timed test, intended to challenge the rapid change in direction while stepping forward, backward and sideways over a low obstacle.
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Functional Reach Test (FRT)
The FRT assesses the subject's stability by measuring the maximum distance an individual can reach forward while standing in a fixed position.
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Dynamic Gait Index (DGI)
Clinical tool to assess gait, balance and risk of fall.
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Modified Fatigue Impact Scale (MFIS)
Questionnaire which evaluates the perceived impact of fatigue on the subscales physical, cognitive and psychosocial functioning.
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Multiple Sclerosis Walking Scale-12 (MSWS-12)
This questionnaire assesses the impact of MS on walking ability.
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Multiple Sclerosis Impact Scale-29 (MSIS-29)
This is an health-rated quality of life questionnaire that assesses the impact of MS on physical and psychological functions.
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Beck Depression Inventory-Second Edition (BDI-II)
This is a 21-item self-report instrument that serves to assess depression severity
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
State Trait Anxiety Inventory (STAI-Y)
STAI-Y is an easy-to-use and interpretative tool to detect and measure anxiety.
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Go-No Go - Test of Attentional Performance T.A.P.
Go-No Go task examine the specific capacity to suppress an inadequate reaction.
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Test of Attentional Performance T.A.P.
In this task divided attention can be explored with computerized "dual-task" test where two stimuli (visual and acoustic) are required simultaneously
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Stroop Color-Word Test (SCWT)
The SCWT explores sustained attention and some aspects of executive function.
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Symbol Digit Modalities Test (SDMT)
The SDMT consists of orally substituting a number for a pseudorandom sequence of geometric figures as quickly as possible for testing executive functions.
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Instrumented Basic Balance Evaluation (IBBE)
Force platform measurement are used as objective markers of subjects' balance ability.
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Instrumented Dual Task (IDT)
Dual cognitive-motor tasks are often used in clinical practice to evaluate the interaction between patients' cognitive and motor ability .
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
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