Video Games Therapy on Balance and Cognitive Functions in Mild to Mode

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

CompletedNot a drug-phase studyRelapsing and progressiveNCT03353974

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Video game therapy

Compared with

  • Balance platform therapy

What it measured

Main measures

  • Timed Up and Go (TUG) test

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

    Walking and mobility

Other measures (14)

  • Four Square Step Test (FSST)

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

  • Functional Reach Test (FRT)

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

  • Dynamic Gait Index (DGI)

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

    Walking and mobility

  • Modified Fatigue Impact Scale (MFIS)

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

    Thinking and memoryFatigue

  • Multiple Sclerosis Walking Scale-12 (MSWS-12)

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

    Walking and mobility

  • Multiple Sclerosis Impact Scale-29 (MSIS-29)

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

    Quality of life (reported by participants)

  • Beck Depression Inventory-Second Edition (BDI-II)

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

    Mood and sleep

  • State Trait Anxiety Inventory (STAI-Y)

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

    Mood and sleep

  • 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

    Thinking and memory

  • Test of Attentional Performance T.A.P.

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

    Thinking and memory

Who could take part

Relapsing and progressive · 18 to 60 · EDSS 4 to 5.5

Show the full 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).

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Dec 2017

    2. Main results due

      Oct 2022

    3. Finished

      Oct 2022

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