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

Multiple Sclerosis Clinical Trial

— ExergaMS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04963335
• Other study ID #: BASEC Nr. 2020-02793
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2021
• Est. completion date: July 31, 2021

Study information

• Verified date: July 2021
• Source: Swiss Federal Institute of Technology
• Contact: Alexandra Schättin, Dr
• Phone: +41446339057
• Email: alexandra.schaettin[@]hest.ethz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Exergame Training
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.

Locations

Country	Name	City	State
Switzerland	ETH Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Eling DeBruin

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Training parameters	Training parameters such as level, points, play time per session, type of game and dual task or single task are collected in a training protocol.; The use (always, sometime or not) of the handrail is noted.	Through intervention completion, 4 to 8 weeks (depending on in- and outpatient)
Other	Training intensity	Training intensity is rated on a 10-point rating scale (1 = very weak, 10 = very,very strong) to assess the perceived cognitive and physical exertion.	Through intervention completion, 4 to 8 weeks (depending on in- and outpatient)
Other	Training progress	The training progress is assessed by video recordings. With these video recordings possible deficiencies or difficulties can be detected.	Through intervention completion, 4 to 8 weeks (depending on in- and outpatient)
Other	Demographic and medical data	The questionnaire assesses general personal information about participants covering general health, medical history and physical activity.; The survey lasts about 10 minutes and is assessed at pre-measurement.	Through study completion, an average of 20 weeks
Other	Activities-specific Balance Confidence	Activities-specific Balance Confidence (ABC) scale assesses the confidence in doing different activities without losing the balance or becoming unsteady.; The ABC scale consists of 16 items where each item is rated from 0% (not confident) to 100% (very confident) and lasts about 5 minutes and is assessed at pre-measurement.	Through study completion, an average of 20 weeks
Other	Multiple Sclerosis Impact	The Multiple Sclerosis Impact Scale (MSIS) assesses the physical and psychological impact of MS.; The MSIS consists of 29 items on a 5-point Likert scale, lasts about 10 minutes and is assessed at pre-measurement.	Through study completion, an average of 20 weeks
Other	Fatigue	The Fatigue Severity Scale (FSSc) assesses the degree of fatigue. The FSSc consists of 9 items on a 7-point Likert scale, lasts about 3 minutes and is assessed at pre-measurement.	Through study completion, an average of 20 weeks
Primary	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
Primary	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)
Primary	Feasibility assessed by attrition rate	Attrition rate is the number of dropouts	Through study completion, an average of 20 weeks
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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