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

NCT ID: NCT03353974

Last Updated: 2023-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2022-10-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Video game therapy

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

Group Type: EXPERIMENTAL

Video game therapy

Intervention Type: DEVICE

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

Balance platform therapy

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.

Group Type: ACTIVE_COMPARATOR

Balance platform therapy

Intervention Type: 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).

Interventions

Video game therapy

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

Intervention Type: DEVICE

Balance platform therapy

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).

Intervention Type: DEVICE

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.

A group of healthy subjects matched for age and sex will be involved for a comparison on the instrumental data (force platforms).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital of Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Sofia Straudi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sofia Straudi, MD, PhD

Role: STUDY_DIRECTOR

Ferrara Rehabilitation Hospital

Locations

Sofia Straudi

Ferrara, Emilia-Romagna, Italy

Ferrara University Hospital

Ferrara, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 34675018 (View on PubMed)

Other Identifiers

MS_Video_Games_Therapy

Identifier Type: -

Identifier Source: org_study_id