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

Multiple Sclerosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03353974
• Other study ID #: MS_Video_Games_Therapy
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: October 1, 2022

Study information

• Verified date: November 2023
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Video game therapy
Video game therapy will be delivered with a commercial video game console (X-Box 360 Kinect, Microsoft, Inc., Redmond, WA).
• 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).

Locations

Country	Name	City	State
Italy	Ferrara University Hospital	Ferrara
Italy	Sofia Straudi	Ferrara	Emilia Romagna

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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