Multiple SclerosisExergaMSNCT04963335
Effects of a User-centered Exergame Training on Motor and Cognitive Functions in PwMS
A study testing Exergame Training in people with Multiple Sclerosis, run by Eling DeBruin at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Exergame Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Mar 2021to 31 Jul 2021
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
ETH Zürich
Zurich, 8093
Alexandra Schättin, Dr, +41446339057, alexandra.schaettin@hest.ethz.ch
Tiziana Schwarz, MSc, +41446330852, tiziana.schwarz@hest.ethz.ch
About this study
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
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.
Read the detailed 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Exergame Training
- Keywords
- Exergame, Multiple Sclerosis, Feasibility, Motor functions, Cognitive functions
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exergame TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Exergame Training |
| Control | No intervention | Participants of the control group are instructed to continue their normal daily routine for eight weeks and to record their physical activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessed by recruitment rate
Recruitment rate is the number of study participants compared to the number of initial planned participants
Measured: 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
Measured: Through intervention completion, 4 to 8 weeks (depending on in- and outpatient)
Feasibility assessed by attrition rate
Attrition rate is the number of dropouts
Measured: 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
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 20 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Through study completion, an average of 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start28 Mar 2021
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eling DeBruin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eling DeBruin, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963335
- Sponsor's protocol ID
- BASEC Nr. 2020-02793
- Acronym
- ExergaMS
- Status last verified
- Jul 2021
- First submitted
- 19 Apr 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04963335
- Acronym / sponsor ID
- ExergaMS / BASEC Nr. 2020-02793
- Conditions
- Multiple Sclerosis
- Keywords
- Exergame, Multiple Sclerosis, Feasibility, Motor functions, Cognitive functions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Eling DeBruinUniversity, hospital or other
- Study start
- 28 Mar 2021 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 15 Jul 2021 (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.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Exergame TrainingParticipants 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. |
| Control | No intervention | –Participants of the control group are instructed to continue their normal daily routine for eight weeks and to record their physical activities. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Exergame TrainingThe 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. | Behavioural | Intervention |
Primary outcome
Feasibility assessed by recruitment rate
Time frame: Through recruitment completion, an average of 12 weeks
Recruitment rate is the number of study participants compared to the number of initial planned participants
Feasibility assessed by adherence rate
Time frame: Through intervention completion, 4 to 8 weeks (depending on in- and outpatient)
Adherence rate is the number of attended training sessions compared to the number of planned trainings
Feasibility assessed by attrition rate
Time frame: Through study completion, an average of 20 weeks
Attrition rate is the number of dropouts
Feasibility assessed by a safety protocol
Time frame: Through study completion, an average of 20 weeks
Safety protocol includes number of adverse events (including serious adverse events) and specific questions about safety issues
System Usability
Time frame: Through study completion, an average of 20 weeks
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.
Feasibility, usability and training experience - Semi-structured interview
Time frame: Through study completion, an average of 20 weeks
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.
7 secondary outcomes
Changes in balance and mobility
Time frame: Through study completion, an average of 20 weeks
Changes in spatio-temporal gait parameters
Time frame: Through study completion, an average of 20 weeks
Changes in information processing speed
Time frame: Through study completion, an average of 20 weeks
Changes in executive functions - inhibition
Time frame: Through study completion, an average of 20 weeks
Changes in executive functions - flexibility
Time frame: Through study completion, an average of 20 weeks
Training experience - Physical Activity Enjoyment Scale
Time frame: Through study completion, an average of 20 weeks
Training experience - Flow Short Scale
Time frame: Through study completion, an average of 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exergame Training in people with Multiple Sclerosis, run by Eling DeBruin at 1 site in Switzerland.
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 5 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: status not confirmed, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Schättin, Dr (+41446339057, alexandra.schaettin@hest.ethz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility assessed by recruitment rate (time frame: Through recruitment completion, an average of 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2021.