Video Games Therapy on Balance and Cognitive Functions in Mild to Moderate Impaired Multiple Sclerosis Patients.
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|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
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Device: Video game therapy Device: Balance platform therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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).
- Timed Up and Go (TUG) test [ Time Frame: 6 weeks ]TUG measures mobility.
- 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.
- 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.
- 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.
- Dynamic Gait Index (DGI) [ Time Frame: 6 weeks, 24 weeks ]Clinical tool to assess gait, balance and risk of fall.
- 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.
- Multiple Sclerosis Walking Scale-12 (MSWS-12) [ Time Frame: 6 weeks, 24 weeks ]This questionnaire assesses the impact of MS on walking ability.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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
- 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
- Stroop Color-Word Test (SCWT) [ Time Frame: 6 weeks, 24 weeks ]The SCWT explores sustained attention and some aspects of executive function.
- 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.
- Instrumented Basic Balance Evaluation (IBBE) [ Time Frame: 6 weeks, 24 weeks ]Force platform measurement are used as objective markers of subjects' balance ability.
- 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 .
- 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.
- Functional Near Infrared Spectroscopy (fNIRS) [ Time Frame: 6 weeks, 24 weeks ]Monitoring of brain metabolism during videogaming session.
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
|Contact: Sofia Straudi, MD, PhDemail@example.com|
|Ferrara, Emilia Romagna, Italy, 44124|
|Contact: Sofia Straudi 0532236185 firstname.lastname@example.org|
|Ferrara University Hospital||Recruiting|
|Ferrara, Italy, 44124|
|Contact: Andrea Baroni, PT +390532238720 email@example.com|
|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|
|Study Director:||Sofia Straudi, MD, PhD||Ferrara Rehabilitation Hospital|