Clinical trial NCT03353974: Video Games Therapy on Balance and Cognitive Functions in Mild to Moderate Impaired Multiple Sclerosis Patients.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Video game therapy
Balance
Cognitive functions
Dual tasking
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 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).

Primary outcomes:
measure: Timed Up and Go (TUG) test
timeFrame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Secondary outcomes:
measure: Four Square Step Test (FSST)
timeFrame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
measure: Functional Reach Test (FRT)
timeFrame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
measure: Dynamic Gait Index (DGI)
timeFrame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
measure: Modified Fatigue Impact Scale (MFIS)
timeFrame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
measure: Multiple Sclerosis Walking Scale-12 (MSWS-12)
timeFrame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
measure: Multiple Sclerosis Impact Scale-29 (MSIS-29)
timeFrame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
measure: Beck Depression Inventory-Second Edition (BDI-II)
timeFrame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
measure: State Trait Anxiety Inventory (STAI-Y)
timeFrame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
measure: Go-No Go - Test of Attentional Performance T.A.P.
timeFrame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
measure: Test of Attentional Performance T.A.P.
timeFrame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
measure: Stroop Color-Word Test (SCWT)
timeFrame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
measure: Instrumented Basic Balance Evaluation (IBBE)
timeFrame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
measure: Instrumented Dual Task (IDT)
timeFrame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Sofia Straudi
state: Emilia Romagna
city: Ferrara
country: Italy
facility: Ferrara University Hospital
Study officials:
affiliation: Ferrara Rehabilitation Hospital
name: Sofia Straudi, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.