Clinical trial NCT04963335: Effects of a User-centered Exergame Training on Motor and Cognitive Functions in PwMS
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Exergame
Multiple Sclerosis
Feasibility
Motor functions
Cognitive functions
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility assessed by recruitment rate
timeFrame: Through recruitment completion, an average of 12 weeks
measure: Feasibility assessed by adherence rate
timeFrame: Through intervention completion, 4 to 8 weeks (depending on in- and outpatient)
measure: Feasibility assessed by attrition rate
timeFrame: Through study completion, an average of 20 weeks
measure: Feasibility assessed by a safety protocol
timeFrame: Through study completion, an average of 20 weeks
measure: System Usability
timeFrame: Through study completion, an average of 20 weeks
measure: Feasibility, usability and training experience - Semi-structured interview
timeFrame: Through study completion, an average of 20 weeks
Secondary outcomes:
measure: Changes in balance and mobility
timeFrame: Through study completion, an average of 20 weeks
measure: Changes in spatio-temporal gait parameters
timeFrame: Through study completion, an average of 20 weeks
measure: Changes in information processing speed
timeFrame: Through study completion, an average of 20 weeks
measure: Changes in executive functions - inhibition
timeFrame: Through study completion, an average of 20 weeks
measure: Changes in executive functions - flexibility
timeFrame: Through study completion, an average of 20 weeks
measure: Training experience - Physical Activity Enjoyment Scale
timeFrame: Through study completion, an average of 20 weeks
measure: Training experience - Flow Short Scale
timeFrame: Through study completion, an average of 20 weeks
Other outcomes:
measure: Training parameters
timeFrame: Through intervention completion, 4 to 8 weeks (depending on in- and outpatient)
measure: Training intensity
timeFrame: Through intervention completion, 4 to 8 weeks (depending on in- and outpatient)
measure: Training progress
timeFrame: Through intervention completion, 4 to 8 weeks (depending on in- and outpatient)
measure: Demographic and medical data
timeFrame: Through study completion, an average of 20 weeks
measure: Activities-specific Balance Confidence
timeFrame: Through study completion, an average of 20 weeks
measure: Multiple Sclerosis Impact
timeFrame: Through study completion, an average of 20 weeks
measure: Fatigue
timeFrame: Through study completion, an average of 20 weeks
Locations:
city: Zürich
country: Switzerland
facility: ETH Zürich
Study officials:
References: