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

NCT03353974 | Completed

• 1 other identifier: MS_Video_Games_Therapy
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; Video game therapy; Balance; Cognitive functions; Dual tasking

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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

• Modified Fatigue Impact Scale (MFIS)

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

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

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

Study Arms (2)

Video game therapy

EXPERIMENTAL

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

Device: Video game therapy

Balance platform therapy

ACTIVE COMPARATOR

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.

Device: Balance platform therapy

Interventions

Video game therapy DEVICE

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

Video game therapy

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).

Balance platform therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital of Ferrara: lead

Study Sites (2)

Sofia Straudi

Ferrara, Emilia-Romagna, 44124, Italy

Location

Ferrara University Hospital

Ferrara, 44124, Italy

Location

Related Publications (1)

• 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.

  PMID: 34675018 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sofia Straudi, MD, PhD

  Ferrara Rehabilitation Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 27, 2017
• Study Start: December 1, 2017
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)