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

NCT04963335 | Unknown DMC

• 1 other identifier: BASEC Nr. 2020-02793
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Exergame; Multiple Sclerosis; Feasibility; Motor functions; Cognitive functions

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• Changes in balance and mobility

  Through study completion, an average of 20 weeks

• Changes in spatio-temporal gait parameters

  Through study completion, an average of 20 weeks

• Changes in information processing speed

  Through study completion, an average of 20 weeks

• Changes in executive functions - inhibition

  Through study completion, an average of 20 weeks

• Changes in executive functions - flexibility

  Through study completion, an average of 20 weeks

Other Outcomes (7)

• Training parameters

  Through intervention completion, 4 to 8 weeks (depending on in- and outpatient)

• Training intensity

  Through intervention completion, 4 to 8 weeks (depending on in- and outpatient)

• Training progress

  Through intervention completion, 4 to 8 weeks (depending on in- and outpatient)

Study Arms (2)

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.

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.

Interventions

Exergame Training BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eling DeBruin: lead

Study Sites (1)

ETH Zürich

Zurich, 8093, Switzerland

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Alexandra Schättin, Dr

CONTACT

+41446339057; alexandra.schaettin@hest.ethz.ch

Tiziana Schwarz, Msc

CONTACT

+4144 6330852; tiziana.schwarz@hest.ethz.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 19, 2021
• First Posted: July 15, 2021
• Study Start: March 28, 2021
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: July 15, 2021

Record last verified: 2021-07

Locations

CH (1)