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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03353974
Recruitment Status : Unknown
Verified January 2018 by Sofia Straudi, University Hospital of Ferrara.
Recruitment status was:  Recruiting
First Posted : November 27, 2017
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Sofia Straudi, University Hospital of Ferrara

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. Another specific aim will be to better explore the neuronal correlate during video game therapy using the Functional Near-infrared Spectroscopy (fNIRS). Finally, patient motivation and satisfaction during VGT and BPT will be monitored with a specific questionnaire.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: Video game therapy Device: Balance platform therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Video Games Therapy on Balance and Cognitive Functions in Mild to Moderate Impaired Multiple Sclerosis Patients. A Pilot Randomized Controlled Trial.
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Video game therapy
Subjects belonging to the experimental group will receive a Video Game Therapy (VGT) protocol using the Xbox console. They will receive 18 sessions of treatment within 6 weeks (3 sessions per week); each session will last 1 hour. Patients 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
Video game therapy will be delivered with a commercial video game console (X-Box 360 Kinect, Microsoft, Inc., Redmond, WA).

Active Comparator: Balance platform therapy
Subjects belonging to the control group will receive the same amount of therapy (18 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
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).




Primary Outcome Measures :
  1. Timed Up and Go (TUG) test [ Time Frame: 6 weeks ]
    TUG measures mobility.


Secondary Outcome Measures :
  1. Four Square Step Test (FSST) [ Time Frame: 6 weeks, 24 weeks ]
    The FSST is a timed test, intended to challenge the rapid change in direction while stepping forward, backward and sideways over a low obstacle.

  2. Functional Reach Test (FRT) [ Time Frame: 6 weeks, 24 weeks ]
    The FRT assesses the subject's stability by measuring the maximum distance an individual can reach forward while standing in a fixed position.

  3. Berg Balance Scale (BBS) [ Time Frame: 6 weeks, 24 weeks ]
    The BBS is an assessment scale of ability to mantain balance, either statically or while performing functional movement.

  4. Dynamic Gait Index (DGI) [ Time Frame: 6 weeks, 24 weeks ]
    Clinical tool to assess gait, balance and risk of fall.

  5. Modified Fatigue Impact Scale (MFIS) [ Time Frame: 6 weeks, 24 weeks ]
    Questionnaire which evaluates the perceived impact of fatigue on the subscales physical, cognitive and psychosocial functioning.

  6. Multiple Sclerosis Walking Scale-12 (MSWS-12) [ Time Frame: 6 weeks, 24 weeks ]
    This questionnaire assesses the impact of MS on walking ability.

  7. Multiple Sclerosis Impact Scale-29 (MSIS-29) [ Time Frame: 6 weeks, 24 weeks ]
    This is an health-rated quality of life questionnaire that assesses the impact of MS on physical and psychological functions.

  8. Functional Assessment of Multiple Sclerosis (FAMS) [ Time Frame: 6 weeks, 24 weeks ]
    This is a quality of life instrument for use in people with MS.

  9. Beck Depression Inventory-Second Edition (BDI-II) [ Time Frame: 6 weeks, 24 weeks ]
    This is a 21-item self-report instrument that serves to assess depression severity

  10. State Trait Anxiety Inventory (STAI-Y) [ Time Frame: 6 weeks, 24 weeks ]
    STAI-Y is an easy-to-use and interpretative tool to detect and measure anxiety.

  11. Intrinsic Motivation Inventory (IMI) [ Time Frame: 6 weeks, 24 weeks ]
    IMI is a multidimensional measurement device intended to assess participant's subjective experience (intrinsic motivation and self-regulation) related to a target activity.

  12. Go-No Go - Test of Attentional Performance T.A.P. [ Time Frame: 6 weeks, 24 weeks ]
    Go-No Go task examine the specific capacity to suppress an inadequate reaction.

  13. Test of Attentional Performance T.A.P. [ Time Frame: 6 weeks, 24 weeks ]
    In this task divided attention can be explored with computerized "dual-task" test where two stimuli (visual and acoustic) are required simultaneously

  14. Paced Auditory Serial Addition Test (PASAT) [ Time Frame: 6 weeks, 24 weeks ]
    The PASAT is a measure of cognitive function that assesses auditory information processing speed and flexibility, as well as calculation ability

  15. Stroop Color-Word Test (SCWT) [ Time Frame: 6 weeks, 24 weeks ]
    The SCWT explores sustained attention and some aspects of executive function.

  16. Symbol Digit Modalities Test (SDMT) [ Time Frame: 6 weeks, 24 weeks ]
    The SDMT consists of orally substituting a number for a pseudorandom sequence of geometric figures as quickly as possible for testing executive functions.

  17. Instrumented Basic Balance Evaluation (IBBE) [ Time Frame: 6 weeks, 24 weeks ]
    Force platform measurement are used as objective markers of subjects' balance ability.

  18. Instrumented Dual Task (IDT) [ Time Frame: 6 weeks, 24 weeks ]
    Dual cognitive-motor tasks are often used in clinical practice to evaluate the interaction between patients' cognitive and motor ability .

  19. Muscle Synergies Analysis [ Time Frame: 6 weeks, 24 weeks ]
    Multiple EMG with surface electrodes signals will be recorded from the lower limbs of the subjects. These signals will be used to estimate the postural muscle synergies of the subjects during the balance tests.

  20. Functional Near Infrared Spectroscopy (fNIRS) [ Time Frame: 6 weeks, 24 weeks ]
    Monitoring of brain metabolism during videogaming session.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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, as calculated using the Kurtzke Expanded Disability Status Scale (EDSS) lower than 5.5, indicating the ability of the subject to stand and walk independently without assistance

Exclusion Criteria:

  • other conditions that may affect motor function
  • impaired cognitive functioning (Mini Mental Status Examination score less than 24)
  • visual deficits (daltonism and visual acuity deficit)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353974


Contacts
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Contact: Sofia Straudi, MD, PhD +390532238720 s.straudi@ospfe.it

Locations
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Italy
Sofia Straudi Recruiting
Ferrara, Emilia Romagna, Italy, 44124
Contact: Sofia Straudi    0532236185    sofia.straudi@gmail.com   
Ferrara University Hospital Recruiting
Ferrara, Italy, 44124
Contact: Andrea Baroni, PT    +390532238720    brnndr3@unife.it   
Sub-Investigator: Sofia Straudi, MD, PhD         
Sub-Investigator: Anna Scotti, MD         
Sub-Investigator: Andrea Baroni, PT, MsC         
Sub-Investigator: Giulia Zani, PsyD         
Sub-Investigator: Fabio Manfredini, MD         
Sub-Investigator: Nicola Lamberti, PhD         
Principal Investigator: Nino Basaglia, MD         
Sponsors and Collaborators
University Hospital of Ferrara
Investigators
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Study Director: Sofia Straudi, MD, PhD Ferrara Rehabilitation Hospital

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Responsible Party: Sofia Straudi, MD, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT03353974    
Other Study ID Numbers: MS_Video_Games_Therapy
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sofia Straudi, University Hospital of Ferrara:
Multiple Sclerosis
Video game therapy
Balance
Cognitive functions
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases