Multiple SclerosisNCT03353974
Video Games Therapy on Balance and Cognitive Functions in Mild to Moderate Impaired Multiple Sclerosis Patients.
A study testing Video game therapy and Balance platform therapy in people with Multiple Sclerosis, run by University Hospital of Ferrara at 2 sites in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Video game therapy and Balance platform therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Dec 2017to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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,
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Sofia Straudi
Ferrara, Emilia-Romagna, 44124
Ferrara University Hospital
Ferrara, 44124
About this study
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.
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
- Being tested
- Video game therapy, Balance platform therapy
- Keywords
- Multiple Sclerosis, Video game therapy, Balance, Cognitive functions, Dual tasking
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video game therapyDevice
Video game therapy will be delivered with a commercial video game console (X-Box 360 Kinect, Microsoft, Inc., Redmond, WA).
Balance platform therapyDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: Balance platform therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go (TUG) test
TUG measures balance and functional mobility.
Measured: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Secondary outcomes (14)
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.
Measured: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
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.
Measured: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Dynamic Gait Index (DGI)
Clinical tool to assess gait, balance and risk of fall.
Measured: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Modified Fatigue Impact Scale (MFIS)
Questionnaire which evaluates the perceived impact of fatigue on the subscales physical, cognitive and psychosocial functioning.
Measured: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Multiple Sclerosis Walking Scale-12 (MSWS-12)
This questionnaire assesses the impact of MS on walking ability.
Measured: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
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.
Measured: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Beck Depression Inventory-Second Edition (BDI-II)
This is a 21-item self-report instrument that serves to assess depression severity
Measured: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
State Trait Anxiety Inventory (STAI-Y)
STAI-Y is an easy-to-use and interpretative tool to detect and measure anxiety.
Measured: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Go-No Go - Test of Attentional Performance T.A.P.
Go-No Go task examine the specific capacity to suppress an inadequate reaction.
Measured: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
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
Measured: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Stroop Color-Word Test (SCWT)
The SCWT explores sustained attention and some aspects of executive function.
Measured: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
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.
Measured: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Instrumented Basic Balance Evaluation (IBBE)
Force platform measurement are used as objective markers of subjects' balance ability.
Measured: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Instrumented Dual Task (IDT)
Dual cognitive-motor tasks are often used in clinical practice to evaluate the interaction between patients' cognitive and motor ability .
Measured: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start1 Dec 2017
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Straudi, University Hospital of Ferrara
- Investigators
- Sofia Straudi, MD, PhD, Study director, Ferrara Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353974
- Sponsor's protocol ID
- MS_Video_Games_Therapy
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2017
- Last updated
- 22 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34675018
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03353974
- Acronym / sponsor ID
- MS_Video_Games_Therapy
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Video game therapy, Balance, Cognitive functions, Dual tasking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video game therapy | Experimental | Device: Video game therapySubjects 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 |
| Balance platform therapy | Active comparator | Device: Balance platform therapySubjects 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video game therapyVideo game therapy will be delivered with a commercial video game console (X-Box 360 Kinect, Microsoft, Inc., Redmond, WA). | Device | Video game therapy |
| Balance platform therapyBalance/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). | Device | Balance platform therapy |
Primary outcome
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.
14 secondary outcomes
Four Square Step Test (FSST)
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Functional Reach Test (FRT)
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Dynamic Gait Index (DGI)
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Modified Fatigue Impact Scale (MFIS)
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
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
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
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
State Trait Anxiety Inventory (STAI-Y)
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
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
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
Stroop Color-Word Test (SCWT)
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Symbol Digit Modalities Test (SDMT)
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Instrumented Basic Balance Evaluation (IBBE)
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Instrumented Dual Task (IDT)
Time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Derived from this study: PubMed 34675018Baroni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sofia Straudi, MD, PhD study director
Ferrara Rehabilitation Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video game therapy and Balance platform therapy in people with Multiple Sclerosis, run by University Hospital of Ferrara at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) test (time frame: Changes from baseline to end of treatment (4 weeks), following changes after 12 weeks follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03353974, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.