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

July 5, 2021 updated by: Eling DeBruin

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
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
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.
No Intervention: Control
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through recruitment completion, an average of 12 weeks
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
Through intervention completion, 4 to 8 weeks (depending on in- and outpatient)
Feasibility assessed by attrition rate
Time Frame: Through study completion, an average of 20 weeks
Attrition rate is the number of dropouts
Through study completion, an average of 20 weeks
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
Through study completion, an average of 20 weeks
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.
Through study completion, an average of 20 weeks
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.
Through study completion, an average of 20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in balance and mobility
Time Frame: Through study completion, an average of 20 weeks

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
Time Frame: Through study completion, an average of 20 weeks

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
Time Frame: Through study completion, an average of 20 weeks

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
Time Frame: Through study completion, an average of 20 weeks

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
Time Frame: Through study completion, an average of 20 weeks

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
Time Frame: Through study completion, an average of 20 weeks

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
Time Frame: Through study completion, an average of 20 weeks

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Training parameters
Time Frame: Through intervention completion, 4 to 8 weeks (depending on in- and outpatient)

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)
Training intensity
Time Frame: Through intervention completion, 4 to 8 weeks (depending on in- and outpatient)
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)
Training progress
Time Frame: Through intervention completion, 4 to 8 weeks (depending on in- and outpatient)
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)
Demographic and medical data
Time Frame: Through study completion, an average of 20 weeks

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
Activities-specific Balance Confidence
Time Frame: Through study completion, an average of 20 weeks

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
Multiple Sclerosis Impact
Time Frame: Through study completion, an average of 20 weeks

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
Fatigue
Time Frame: Through study completion, an average of 20 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eling DeBruin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2021

Primary Completion (Anticipated)

July 31, 2021

Study Completion (Anticipated)

July 31, 2021

Study Registration Dates

First Submitted

April 19, 2021

First Submitted That Met QC Criteria

July 5, 2021

First Posted (Actual)

July 15, 2021

Study Record Updates

Last Update Posted (Actual)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 5, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BASEC Nr. 2020-02793

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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