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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Device: Balance platform therapy; Device: Video game therapy

• Registration Number: NCT03353974
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-16
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-27
• Study Start: 2017-12-01
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balance platform therapy	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.
Video game therapy	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

Primary Outcome Measures

Name	Time	Method
Timed Up and Go (TUG) test	Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up	TUG measures balance and functional mobility.

Secondary Outcome Measures

Name	Time	Method
Beck Depression Inventory-Second Edition (BDI-II)	Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up	This is a 21-item self-report instrument that serves to assess depression severity
Dynamic Gait Index (DGI)	Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up	Clinical tool to assess gait, balance and risk of fall.
Modified Fatigue Impact Scale (MFIS)	Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up	Questionnaire which evaluates the perceived impact of fatigue on the subscales physical, cognitive and psychosocial functioning.
Multiple Sclerosis Walking Scale-12 (MSWS-12)	Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up	This questionnaire assesses the impact of MS on walking ability.
Multiple Sclerosis Impact Scale-29 (MSIS-29)	Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up	This is an health-rated quality of life questionnaire that assesses the impact of MS on physical and psychological functions.
Go-No Go - Test of Attentional Performance T.A.P.	Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up	Go-No Go task examine the specific capacity to suppress an inadequate reaction.
Symbol Digit Modalities Test (SDMT)	Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up	The SDMT consists of orally substituting a number for a pseudorandom sequence of geometric figures as quickly as possible for testing executive functions.
Four Square Step Test (FSST)	Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up	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)	Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up	The FRT assesses the subject's stability by measuring the maximum distance an individual can reach forward while standing in a fixed position.
Instrumented Basic Balance Evaluation (IBBE)	Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up	Force platform measurement are used as objective markers of subjects' balance ability.
State Trait Anxiety Inventory (STAI-Y)	Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up	STAI-Y is an easy-to-use and interpretative tool to detect and measure anxiety.
Stroop Color-Word Test (SCWT)	Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up	The SCWT explores sustained attention and some aspects of executive function.
Test of Attentional Performance T.A.P.	Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up	In this task divided attention can be explored with computerized "dual-task" test where two stimuli (visual and acoustic) are required simultaneously
Instrumented Dual Task (IDT)	Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up	Dual cognitive-motor tasks are often used in clinical practice to evaluate the interaction between patients' cognitive and motor ability .

Trial Locations

Locations (2)

Sofia Straudi; 🇮🇹 Ferrara, Emilia Romagna, Italy

Ferrara University Hospital; 🇮🇹 Ferrara, Italy