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

Primary Purpose

Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Video game therapy
Balance platform therapy
Sponsored by
University Hospital of Ferrara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Video game therapy, Balance, Cognitive functions, Dual tasking

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sofia StraudiRecruiting
  • Ferrara University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Video game therapy

Balance platform therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Timed Up and Go (TUG) test
TUG measures balance and functional mobility.

Secondary Outcome Measures

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.
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.
Dynamic Gait Index (DGI)
Clinical tool to assess gait, balance and risk of fall.
Modified Fatigue Impact Scale (MFIS)
Questionnaire which evaluates the perceived impact of fatigue on the subscales physical, cognitive and psychosocial functioning.
Multiple Sclerosis Walking Scale-12 (MSWS-12)
This questionnaire assesses the impact of MS on walking ability.
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.
Beck Depression Inventory-Second Edition (BDI-II)
This is a 21-item self-report instrument that serves to assess depression severity
State Trait Anxiety Inventory (STAI-Y)
STAI-Y is an easy-to-use and interpretative tool to detect and measure anxiety.
Go-No Go - Test of Attentional Performance T.A.P.
Go-No Go task examine the specific capacity to suppress an inadequate reaction.
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
Stroop Color-Word Test (SCWT)
The SCWT explores sustained attention and some aspects of executive function.
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.
Instrumented Basic Balance Evaluation (IBBE)
Force platform measurement are used as objective markers of subjects' balance ability.
Instrumented Dual Task (IDT)
Dual cognitive-motor tasks are often used in clinical practice to evaluate the interaction between patients' cognitive and motor ability .

Full Information

First Posted
November 16, 2017
Last Updated
August 17, 2021
Sponsor
University Hospital of Ferrara
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1. Study Identification

Unique Protocol Identification Number
NCT03353974
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Ferrara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Video game therapy, Balance, Cognitive functions, Dual tasking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Video game therapy
Arm Type
Experimental
Arm Description
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
Arm Title
Balance platform therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Video game therapy
Intervention Description
Video game therapy will be delivered with a commercial video game console (X-Box 360 Kinect, Microsoft, Inc., Redmond, WA).
Intervention Type
Device
Intervention Name(s)
Balance platform therapy
Intervention Description
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 Outcome Measure Information:
Title
Timed Up and Go (TUG) test
Description
TUG measures balance and functional mobility.
Time Frame
Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Secondary Outcome Measure Information:
Title
Four Square Step Test (FSST)
Description
The FSST is a timed test, intended to challenge the rapid change in direction while stepping forward, backward and sideways over a low obstacle.
Time Frame
Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Title
Functional Reach Test (FRT)
Description
The FRT assesses the subject's stability by measuring the maximum distance an individual can reach forward while standing in a fixed position.
Time Frame
Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Title
Dynamic Gait Index (DGI)
Description
Clinical tool to assess gait, balance and risk of fall.
Time Frame
Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Title
Modified Fatigue Impact Scale (MFIS)
Description
Questionnaire which evaluates the perceived impact of fatigue on the subscales physical, cognitive and psychosocial functioning.
Time Frame
Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Title
Multiple Sclerosis Walking Scale-12 (MSWS-12)
Description
This questionnaire assesses the impact of MS on walking ability.
Time Frame
Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Title
Multiple Sclerosis Impact Scale-29 (MSIS-29)
Description
This is an health-rated quality of life questionnaire that assesses the impact of MS on physical and psychological functions.
Time Frame
Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Title
Beck Depression Inventory-Second Edition (BDI-II)
Description
This is a 21-item self-report instrument that serves to assess depression severity
Time Frame
Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Title
State Trait Anxiety Inventory (STAI-Y)
Description
STAI-Y is an easy-to-use and interpretative tool to detect and measure anxiety.
Time Frame
Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Title
Go-No Go - Test of Attentional Performance T.A.P.
Description
Go-No Go task examine the specific capacity to suppress an inadequate reaction.
Time Frame
Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Title
Test of Attentional Performance T.A.P.
Description
In this task divided attention can be explored with computerized "dual-task" test where two stimuli (visual and acoustic) are required simultaneously
Time Frame
Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Title
Stroop Color-Word Test (SCWT)
Description
The SCWT explores sustained attention and some aspects of executive function.
Time Frame
Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Title
Symbol Digit Modalities Test (SDMT)
Description
The SDMT consists of orally substituting a number for a pseudorandom sequence of geometric figures as quickly as possible for testing executive functions.
Time Frame
Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Title
Instrumented Basic Balance Evaluation (IBBE)
Description
Force platform measurement are used as objective markers of subjects' balance ability.
Time Frame
Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Title
Instrumented Dual Task (IDT)
Description
Dual cognitive-motor tasks are often used in clinical practice to evaluate the interaction between patients' cognitive and motor ability .
Time Frame
Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sofia Straudi, MD, PhD
Phone
+390532238720
Email
s.straudi@ospfe.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofia Straudi, MD, PhD
Organizational Affiliation
Ferrara Rehabilitation Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Sofia Straudi
City
Ferrara
State/Province
Emilia Romagna
ZIP/Postal Code
44124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofia Straudi
Phone
0532236185
Email
sofia.straudi@gmail.com
Facility Name
Ferrara University Hospital
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Baroni, PT
Phone
+390532238720
Email
brnndr3@unife.it
First Name & Middle Initial & Last Name & Degree
Sofia Straudi, MD, PhD
First Name & Middle Initial & Last Name & Degree
Anna Scotti, MD
First Name & Middle Initial & Last Name & Degree
Andrea Baroni, PT, PhD
First Name & Middle Initial & Last Name & Degree
Fabio Manfredini, MD
First Name & Middle Initial & Last Name & Degree
Nicola Lamberti, PhD
First Name & Middle Initial & Last Name & Degree
Nino Basaglia, MD
First Name & Middle Initial & Last Name & Degree
Giada Milani, Psy, MsC
First Name & Middle Initial & Last Name & Degree
Giulia Fregna, PT

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34675018
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.
Results Reference
derived

Learn more about this trial

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

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