Exergames Balance Program in Neurorehabilitation

May 12, 2020 updated by: Evelyne Wiskerke, Klinik Valens

Exergames are games that require physical movements and are used with a therapeutic purpose, e.g. to improve strength, balance or flexibility. Exergames rely on technologies that track body movements and reaction, to perform exercises in a persuasive environment. Exergames are increasingly used in rehabilitation to improve motor function and independence of patients. Exergames are increasingly used for self-regulated exercise. However, usability of the MMGO is reduced by the fact that 1) therapists are needed to choose exercises and 2) adapt the exercise program depending on patients' ability level, and 3) patients' motivation reduces after about 5 sessions if exercises are not adapted and variation of exercises is low.

The planned study aims to overcome the given limitations and thus improve usability. Using routine data of patients exercising with MMGO and clinical outcome measures this study will investigate the relationship between scores on the MMGO and on clinical outcome measures and how these scores change over time. In addition, the study will determine the relative difficulty levels of each exercise and its difficulty level in relation to participants' balance ability.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Exergames are games that require physical movements and are used with a therapeutic purpose, e.g. to improve strength, balance or flexibility. Exergames rely on technologies that track body movements and reaction, to perform exercises in a persuasive environment. Exergames are increasingly used in rehabilitation to improve motor function and independence of patients. In the Rehabilitation Center Valens, the exergames of 'MindMotion GO' (MMGO) are used to improve balance in patients with neurological diseases such as multiple sclerosis and stroke. Patients' movements are captured by a Kinect camera. With their body movements, patients control an avatar that has to be moved goal directed. Several games are available and during rehabilitation therapists select games and adapt the exercise program according to patients' progress. In this way, trunk control and balance can be trained in sitting and standing.

Rehabilitation is effective to improve independence in activities of daily living (ADL) for patients with Multiple Sclerosis and Stroke. Higher levels of mobility and balance are associated with better outcomes regarding ADL independence. Higher treatment dose is positively associated with ADL and balance improvement. Self-regulated exercise, whereby patients perform given exercises independently, is recommended. Exergames are increasingly used for self-regulated exercise. However, usability of the MMGO is reduced by the fact that 1) therapists are needed to choose exercises and 2) adapt the exercise program depending on patients' ability level, and 3) patients' motivation reduces after about 5 sessions if exercises are not adapted and variation of exercises is low.

The planned study aims to overcome the given limitations and thus improve usability. Using routine data of patients exercising with MMGO and clinical outcome measures this study will investigate the relationship between scores on the MMGO and on clinical outcome measures and how these scores change over time. In addition, researchers will determine the relative difficulty levels of each exercise and its difficulty level in relation to participants' balance ability.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Contacts and Locations

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

Study Locations

  • Switzerland
    • SG
      • Valens, SG, Switzerland, 7317
        • Rehazentrum Valens

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

MS patients that come to the rehabiliation center for a minimum of 3 weeks rehabiliation. Patients have a EDSS score between 3.0 and 6.5 and have balance problems as shown by the BBS.

Subacute stroke patients that come into Rehabiliation for a minimum of 4 weeks and show balance problems, according to the BBS.

Description

Inclusion Criteria:

  • Patients with a Stroke or Multiple sclerosis (EDSS 3-6.5), confirmed by a neurologist
  • Age > 18 years
  • Referred for a minimum of 3 weeks in-patient rehabilitation
  • Reduced balance (< 52/56 points on the Berg Balance Scale)
  • Signed informed consent

Exclusion Criteria:

  • Co-morbidities interfering with exergame performance, walking ability and balance (e.g. visual or cognitive impairments, psychiatric disorders, musculoskeletal problems)

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with Stroke
30 Patients suffering a stroke will be included in the study. After clinical measurements of balance, gait, trunk control and cognition, patients will train 2-3 times a week for on average 4 weeks with the MindMotion GO system. Afterwards, clinical measures will be repeated.
Device: MindMotion GO
Patients will train trunk control and balance using the MindMotion GO device 2-3 times a week. They will perform exergames in sitting or standing, according to their balance level.
Patients with Multiple Sclerosis
50 Patients suffering multiple sclerosis will be included in the study. After clinical measurements of balance, gait, trunk control and cognition, patients will train 2-3 times a week for on average 3 weeks with the MindMotion GO system. Afterwards, clinical measures will be repeated.
Device: MindMotion GO
Patients will train trunk control and balance using the MindMotion GO device 2-3 times a week. They will perform exergames in sitting or standing, according to their balance level.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Game score of performed MindMotion GO Exergames
Time Frame: 3-4 weeks
For each game the MindMotion GO device provides a score (0=poorest -100=best performance) after completion of the game.
3-4 weeks
Change in Balance (Berg Balance Scale)
Time Frame: Baseline, weekly, and after 3-4 weeks of training
The Berg Balance Scale measures stattic balance and fall risk in adults. It consists of The Berg Balance Scale is used to asses Balance. The Scale consists of 14 items, for each item the minimum score is 0 points, the maximum score is 4 points. A total amount of 56 points can be achieved on the Berg Balance Scale which indicates a normal balance for adults. A score lower than 45 points in elderly indicates that individuals may be at greater risk of falling.
Baseline, weekly, and after 3-4 weeks of training
Change in trunk control and sitting Balance (Trunk Impairment Scale)
Time Frame: Baseline and after 3-4 weeks of training
The Trunk Impairment Scale assesses stattic and dynamic sitting balance and coordination of trunk movement. The test consists of 17 items with a minimum score of 0 and a maximum score of 23 points, which is calculated by adding up the scores from the subscales (0-7 Points for static sitting Balance, 0-10 Points for dynamic sitting Balance, 0-6 Points for coordination), with a higher scores for better trunk control.
Baseline and after 3-4 weeks of training
Change in mobility
Time Frame: Baseline and after 3-4 weeks of training
The Timed Up and GO Test assess mobility, balance, walking abaility and fall risk. The patient is asked to stand up from a chair, walk a distance of 3 meters, turn, walk back to the chair and sit down again. The performance of the patient is measured by measuring the time it takes to perform this task. With a shorter time, representing better mobility.
Baseline and after 3-4 weeks of training
Change in dynamic balance during gait
Time Frame: Baseline and after 3-4 weeks of training
The Dynamic Gait Index assesses the ability to modify balance while walking. Eight items are scored from 0 to 4 points, showing the amount of dysfunction the patient shows in executing the tasks. The Minimum score is 0 Points, the maximum score is 24 points, indicating a better balance while walking.
Baseline and after 3-4 weeks of training
Change in the perceived Walking ability
Time Frame: Baseline and after 3-4 weeks of training
The MS Walking scale 12, is a 12-item questionnaire to assess the impact of MS on the walking ability. The questions are scored 1 to 5, with 1 meaning no limitation and 5 meaning extreme limitation on gait related activites. The total score is calculated into percentages, with a higher percentage meaning a higher perceived impact of the MS on walking ability.
Baseline and after 3-4 weeks of training
Subjective difficulty of performed MindMotion GO Exerames
Time Frame: 3-4 weeks
The patient is asked to score how difficult it was to perform the MindMotion GO game in question. With 0 being verry easy, and 5 being impossible to execute this game.
3-4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Intrinsic Motivation during the treatment phase
Time Frame: Baseline and after 3-4 weeks of training
Intrinsic motivation inventory assesses motivation and satisfaction with therapy.
Baseline and after 3-4 weeks of training
Montreal cognitive assessment
Time Frame: Baseline and after 3-4 weeks of training.
The MOCA is a test to rapidly screen for mild cognitive dysfunctions. It assessess different cognitive domains such as, executive functions, attention and concentration, executive functions, memory, language and calculations. The maximum score is 30 points, and is acquired when all items are answered correctly. A score of 26 and higher is generally considered as normal.
Baseline and after 3-4 weeks of training.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Klinik Valens

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
KU Leuven
Mindmaze SA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jan Kool, Kliniken Valens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MindMaze

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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