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

Status unknownNot a drug-phase studyMS (type not specified)NCT04963335

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Exergame Training

What it measured

Main measures

  • Feasibility assessed by recruitment rate

    Through recruitment completion, an average of 12 weeks

    Feasibility
  • Feasibility assessed by adherence rate

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

    Quality of life (reported by participants)Feasibility
  • Feasibility assessed by attrition rate

    Through study completion, an average of 20 weeks

    Feasibility
  • Feasibility assessed by a safety protocol

    Through study completion, an average of 20 weeks

    SafetyFeasibility
  • System Usability

    Through study completion, an average of 20 weeks

  • Feasibility, usability and training experience - Semi-structured interview

    Through study completion, an average of 20 weeks

    SafetyFeasibility

Other measures (7)

  • Changes in balance and mobility

    Through study completion, an average of 20 weeks

    Walking and mobility
  • Changes in spatio-temporal gait parameters

    Through study completion, an average of 20 weeks

    Walking and mobility
  • Changes in information processing speed

    Through study completion, an average of 20 weeks

    Thinking and memory
  • 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

  • Training experience - Physical Activity Enjoyment Scale

    Through study completion, an average of 20 weeks

    Physical function
  • Training experience - Flow Short Scale

    Through study completion, an average of 20 weeks

    Fatigue

Who could take part

MS (type not specified) · 30 to 85

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

    1. Started

      Mar 2021

    2. Main results due

      Jul 2021

    3. Finished

      Jul 2021

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