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

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

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 Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Device: Video game therapy; Device: Balance platform therapy

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Ferrara, Italy, 44124
    • Ferrara University Hospital
  • Emilia Romagna
    • Ferrara, Emilia Romagna, Italy, 44124
      • Sofia Straudi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 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; 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 (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; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital of Ferrara
• Investigators: Study Director: Sofia Straudi, MD, PhD, Ferrara Rehabilitation Hospital

Publications and helpful links

General Publications

• Baroni A, Fregna G, Milani G, Severini G, Zani G, Basaglia N, Straudi S. Video game therapy on mobility and dual tasking in multiple sclerosis: study protocol for a randomised controlled trial. BMJ Open. 2021 Oct 21;11(10):e052005. doi: 10.1136/bmjopen-2021-052005.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 27, 2017

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Balance; Cognitive functions; Dual tasking; Video game therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: MS_Video_Games_Therapy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No