Skip to main content
OpenTrials
Completed

NCT Number: NCT03353974

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sofia Straudi, Ferrara, Emilia-Romagna, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Video game therapy

Device

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

Balance platform therapy

Device

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).

Primary outcomes

  1. Timed Up and Go (TUG) test

    Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up

    TUG measures balance and functional mobility.

Secondary outcomes

  1. Four Square Step Test (FSST)

    Time frame: 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.

  2. Functional Reach Test (FRT)

    Time frame: 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.

  3. Dynamic Gait Index (DGI)

    Time frame: 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.

  4. Modified Fatigue Impact Scale (MFIS)

    Time frame: 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.

  5. Multiple Sclerosis Walking Scale-12 (MSWS-12)

    Time frame: 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.

  6. Multiple Sclerosis Impact Scale-29 (MSIS-29)

    Time frame: 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.

  7. Beck Depression Inventory-Second Edition (BDI-II)

    Time frame: 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

  8. State Trait Anxiety Inventory (STAI-Y)

    Time frame: 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.

  9. Go-No Go - Test of Attentional Performance T.A.P.

    Time frame: 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.

  10. Test of Attentional Performance T.A.P.

    Time frame: 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

  11. Stroop Color-Word Test (SCWT)

    Time frame: 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.

  12. Symbol Digit Modalities Test (SDMT)

    Time frame: 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.

  13. Instrumented Basic Balance Evaluation (IBBE)

    Time frame: 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.

  14. Instrumented Dual Task (IDT)

    Time frame: 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 .

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Official study 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.

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Nov 27, 2017
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.