Effects of a User-centered Exergame Training on Motor and Cognitive Functions in PwMS

Study Overview
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Brief Summary
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This study examines the feasibility and preliminary effects of user-centered exergames (video game-based physical exercise) in persons with multiple sclerosis (PwMS). The user-centered exergames were developed within a interdisciplinary team to meet the requirements of the end-users. The individualized exergames were designed for the Dividat Senso, a pressure sensitive plate connected to a personal computer and a frontal screen. This concurrent motor-cognitive training aims to improve motor and cognitive functions in an ecological valid setting. The cognitive functions are triggered by specific stimuli in the game scenarios. The video games are controlled via specific (whole body) movements as steps, weight shifting, jumps, and arm movements. The training focus is mainly on balance and coordination as well as executive functions and attention. Furthermore, the meaningful games (colorful and appealing visuals) were designed to motivate the players to move. Participants are allocated to the either the intervention group or the control group (quasi-randomization). Participants in the intervention group perform 16 training session over a period of 4 to 8 weeks (depending on in- or out-patient). One training session lasts between 15-25 minutes. Since the difficulty of the games is adaptive to the ability level of each participant, they should neither be over- nor under-challenged. Participates in the control group continue their normal daily routine over 8 weeks. Measurements are performed before, in-between, and after the intervention period to assess feasibility parameters as well as motor and cognitive functions in all participants.

Detailed Description
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The study was designed to examine the feasibility of the intervention as well as to get preliminary results about the effects of the user-centered exergame training on motor and cognitive functions in persons with multiple sclerosis (PwMS). The entire study last 5 months (March 2021 to July 2021) and is performed in three study locations (two rehabilitation clinics and one physiotherapy). PwMS are informed by their local physiotherapists and research associates about the study. All interested PwMS are then screened for eligibility. A sample size of 30 PwMS is anticipated where 15 participants are allocated to the intervention group and 15 participants to the control group (quasi-randomization). Measurements are performed before, in-between, and after the intervention period to assess feasibility parameters as well as motor and cognitive functions in all participants. Intervention group:The user-centered exergames were developed within a interdisciplinary team to meet the requirements of the end-users. The individualized exergames were designed for the Dividat Senso, a pressure sensitive plate connected to a personal computer and a frontal screen. The pressure-sensitive plate allows a precise analysis of the user's movements through several high-resolution sensors. Furthermore, this plate detects position and timing information that are then used to provide the user with real-time feedback and/or game adaptations. To support users with potential balance issues and to avoid fall events, a handrail is mounted around the plate.This concurrent motor-cognitive training aims to improve motor and cognitive functions in an ecological valid setting. The cognitive functions are triggered by specific stimuli in the game scenarios. The video games are controlled via specific (whole body) movements as steps, weight shifting, jumps, and arm movements. The training focus is mainly on multi-tasking, balance and coordination as well as executive functions and attention. Furthermore, the meaningful games (colorful and appealing visuals) were designed to motivate the players to move. Participants in the intervention group perform 16 training session over a period of 4 to 8 weeks (depending on in- or out-patient). One training session lasts between 15-25 minutes. Since the difficulty of the games is adaptive to the ability level of each participant, they should neither be over- nor under-challenged. Each participant starts the exergame training at the lowest level to get familiar with the game control system. As the exergame will automatically adapt (individual progression) during play time, participants are challenged at their individual motor and cognitive level. Furthermore, participants write down the amount, type, and duration of activities besides the exergames training in an activity diary. Control group:Participants of the control group are instructed to continue their normal daily activities over the period of eight weeks. To evaluate the amount of active time, the participants get an activity diary where they can write down the amount, type, and duration of their activities.

Official Title
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Effects of a User-centered Exergame Training on Motor and Cognitive Functions in Persons With Multiple Sclerosis: A Pilot Quasi-Randomized Controlled Trial

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Exergame Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of MS Able to provide written informed consent and understand instructions Able to play the exergames by stepping and weight shifting Able to walk at least 12m with or without walking aid Visual acuity with correction sufficient to work on a TV screen Exclusion Criteria: Presence of musculoskeletal conditions that affect training performance Excessive fatigue that impairs training participation Exercise intolerance that prevents training participation Rapidly progressive or terminal illness Acute or unstable chronic illness

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants perform 16 exergame training (video game-based physical exercise) sessions over a period of 4 to 8 weeks (depending on in-patient or out-patient). Each training lasts between 15 to 25 minutes. Exergames automatically adjust the game difficulty to the abilities of the respective participant. | Behavioral: Exergame Training<br>* The individualized exergames were designed for a pressure sensitive plate connected to a personal computer and a frontal screen. The pressure-sensitive plate allows a precise analysis of the user's movements. This concurrent motor-cognitive training aims to improve motor and cognitive functions in an ecological valid setting. The cognitive functions are triggered by specific stimuli in the game scenarios. The video games are controlled via specific (whole body) movements as steps, weight shifting, jumps, and arm movements. The training focus is mainly on multi-tasking, balance and coordination as well as executive functions and attention. Furthermore, the meaningful games (colorful and appealing visuals) were designed to motivate the players to move. As the exergame will automatically adapt (individual progression) during play time, participants are challenged at their individual motor and cognitive level.<br>|
| No Intervention: Control<br>Participants of the control group are instructed to continue their normal daily routine for eight weeks and to record their physical activities. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility assessed by recruitment rate | Recruitment rate is the number of study participants compared to the number of initial planned participants | Through recruitment completion, an average of 12 weeks | 
| Feasibility assessed by adherence rate | Adherence rate is the number of attended training sessions compared to the number of planned trainings | Through intervention completion, 4 to 8 weeks (depending on in- and outpatient) | 
| Feasibility assessed by attrition rate | Attrition rate is the number of dropouts | Through study completion, an average of 20 weeks | 
| Feasibility assessed by a safety protocol | Safety protocol includes number of adverse events (including serious adverse events) and specific questions about safety issues | Through study completion, an average of 20 weeks | 
| System Usability | The System Usability Scale interprets the system usability from 1 to 100, similar to a percentage score. A SUS score of at least 70 has to be reached to have an acceptable solution (52 = ok, 73 = good, 85 = excellent, 100 = best imaginable). The SUS consists of 10 items on a 5-point Likert scale and lasts about 3 minutes. The SUS is assessed at post-measurement. | Through study completion, an average of 20 weeks | 
| Feasibility, usability and training experience - Semi-structured interview | The semi-structured interview contains pre-defined questions about user's gameplay experiences related to their body, controller, experience, virtual game scenario and safety. The interview lasts about 20 minutes and is assessed at post-measurement. | Through study completion, an average of 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in balance and mobility | Balance and mobility are assessed with the Timed Up and Go Test. Time needed to complete the assessment is recorded. Test duration is about 5 to 10 minutes and is assessed at pre- and post-measurement. | Through study completion, an average of 20 weeks | 
| Changes in spatio-temporal gait parameters | Gait analysis is conducted under single (walking; normal speed) and dual (walking + counting; normal speed) over 13 meters to assess spatio-temproal gait parameters ((gait speed, step length, gait variability and double support time). Gait parameters are assessed via the system Physiolog. Test duration is about 10 to 15 minutes and is assessed at pre- and post-measurement. | Through study completion, an average of 20 weeks | 
| Changes in information processing speed | Simple reaction time test is performed on a personal computer recording reaction time [ms] and errors. Test duration is about 5 minutes and is assessed at pre- and post-measurement. | Through study completion, an average of 20 weeks | 
| Changes in executive functions - inhibition | Flanker test is performed on a personal computer recording reaction time [ms] and errors. Test duration is about 10 minutes and is assessed at pre- and post-measurement. | Through study completion, an average of 20 weeks | 
| Changes in executive functions - flexibility | Trail Making Test A & B is performed on a personal computer recording reaction time [ms] and errors. Test duration is about 10 minutes and is assessed at pre- and post-measurement. | Through study completion, an average of 20 weeks | 
| Training experience - Physical Activity Enjoyment Scale | The Physical Activity Enjoyment Scale (PACES) measures enjoyment in physical activity environments. The PACES consists of 18 bipolar items on a 7-point Likert scale, lasts about 5 minutes, and is assessed after the first and last training session | Through study completion, an average of 20 weeks | 
| Training experience - Flow Short Scale | The Flow Short Scale (FFS) assesses the flow experience for training experiences. The FSS consists of 13 items on a 5-point Likert scale and lasts about 5 minutes, and is assessed after the first and last training session. | Through study completion, an average of 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exergame, Multiple Sclerosis, Feasibility, Motor functions, Cognitive functions