Video Games Therapy on Balance and Cognitive Functions in Mild to Moderate Impaired Multiple Sclerosis Patients.

Study Overview
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Brief Summary
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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.

Official Title
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The Role of Video Games Therapy on Balance and Cognitive Functions in Mild to Moderate Impaired Multiple Sclerosis Patients. A Pilot Randomized Controlled Trial.

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: Video game therapy
* Device: Balance platform therapy


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Video game therapy<br>Subjects belonging to the experimental group will receive a Video Game Therapy (VGT) protocol using the Xbox console. They will receive 12 sessions of treatment within 4 weeks (3 sessions per week); each session will last 1 hour. To manage possible absence lasting one or more treatment sessions, a potential window of 5 weeks will be set to ensure the achievement of all 12 sessions. Will be required to concentrate in games whose major purposes are increasing balance, selective attention and attention shifting. During sessions the patient will be carefully controlled by a researcher who will prevent the risk of falling | Device: Video game therapy<br>* Video game therapy will be delivered with a commercial video game console (X-Box 360 Kinect, Microsoft, Inc., Redmond, WA).<br>|
| Active Comparator: Balance platform therapy<br>Subjects belonging to the control group will receive the same amount of therapy (12 sessions) using a balance platform (Biodex Medical Systems, Inc., Shirley, NY). Balance/rebalancing, postural stability and weight-shifting exercises ill be administered with and without visual feedback. During the first session, the tasks will be performed at an entry level, and the exercise progression will be adjusted over time according to the patients' functional level (intermediate and difficult level). Balance platform therapy offered visual feedback and knowledge of performance (augmented feedback). The physiotherapist, as during VGT, provided additional external feedback. | Device: Balance platform therapy<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go (TUG) test | TUG measures balance and functional mobility. | Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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 | 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. | 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. | 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. | 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 . | Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Balance, Multiple Sclerosis, Video game therapy, Cognitive functions, Dual tasking