StrokeNCT03993275
Exergames Balance Program in Neurorehabilitation
An observational study of Stroke and Multiple Sclerosis, run by Klinik Valens at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Multiple Sclerosis, Balance Disorders
- What is being tested?
- MindMotion GO
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Oct 2018to 15 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Co-morbidities interfering with exergame performance, walking ability and balance (e.g. visual or cognitive impairments, psychiatric disorders, musculoskeletal problems)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Stroke, Multiple Sclerosis, Balance Disorders
- Being tested
- MindMotion GO
- Keywords
- Trunk Control, Exergames
- Medical subject headings
- Stroke, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindMotion GODevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MindMotion GO | |
| 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. Receives: Device: MindMotion GO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Game score of performed MindMotion GO Exergames
For each game the MindMotion GO device provides a score (0=poorest -100=best performance) after completion of the game.
Measured: 3-4 weeks
Change in Balance (Berg Balance Scale)
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.
Measured: Baseline, weekly, and after 3-4 weeks of training
Change in trunk control and sitting Balance (Trunk Impairment Scale)
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.
Measured: Baseline and after 3-4 weeks of training
Change in mobility
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.
Measured: Baseline and after 3-4 weeks of training
Change in dynamic balance during gait
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.
Measured: Baseline and after 3-4 weeks of training
Change in the perceived Walking ability
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.
Measured: Baseline and after 3-4 weeks of training
Subjective difficulty of performed MindMotion GO Exerames
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.
Measured: 3-4 weeks
Secondary outcomes (2)
Change in Intrinsic Motivation during the treatment phase
Intrinsic motivation inventory assesses motivation and satisfaction with therapy.
Measured: Baseline and after 3-4 weeks of training
Montreal cognitive assessment
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.
Measured: Baseline and after 3-4 weeks of training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start10 Oct 2018
- Primary completion15 Jan 2020
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik Valens
- Sponsor type
- University, hospital or other
- Collaborators
- Mindmaze SA, KU Leuven
- Responsible party
- Principal investigator, Evelyne Wiskerke, Klinik Valens
- Investigators
- Jan Kool, Principal investigator, Kliniken Valens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993275
- Sponsor's protocol ID
- MindMaze
- Status last verified
- May 2020
- First submitted
- 6 May 2019
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Wiskerke E, Kool J, Hilfiker R, Sattelmayer KM, Verheyden G. Determining the Optimal Virtual Reality Exergame Approach for Balance Therapy in Persons With Neurological Disorders Using a Rasch Analysis: Longitudinal Observational Study. JMIR Serious Games. 2022 Mar 22;10(1):e30366. doi: 10.2196/30366.
PubMed 35315785
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exergames Balance Program in Neurorehabilitation
- ClinicalTrials.gov ID
- NCT03993275
- Acronym / sponsor ID
- MindMaze
- Conditions
- Stroke, Multiple Sclerosis, Balance Disorders
- Keywords
- Trunk Control, Exergames
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Klinik ValensUniversity, hospital or other
- Collaborators
- Mindmaze SA, KU Leuven
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 15 Jan 2020 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Stroke | – | Device: MindMotion GO30 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. |
| Patients with Multiple Sclerosis | – | Device: MindMotion GO50 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Co-morbidities interfering with exergame performance, walking ability and balance (e.g. visual or cognitive impairments, psychiatric disorders, musculoskeletal problems)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindMotion GOPatients 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. | Device | Patients with Multiple Sclerosis, Patients with Stroke |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Change in Intrinsic Motivation during the treatment phase
Time frame: Baseline and after 3-4 weeks of training
Montreal cognitive assessment
Time frame: Baseline and after 3-4 weeks of training.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Derived from this study: PubMed 35315785Wiskerke E, Kool J, Hilfiker R, Sattelmayer KM, Verheyden G. Determining the Optimal Virtual Reality Exergame Approach for Balance Therapy in Persons With Neurological Disorders Using a Rasch Analysis: Longitudinal Observational Study. JMIR Serious Games. 2022 Mar 22;10(1):e30366. doi: 10.2196/30366.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Kool principal investigator
Kliniken Valens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Multiple Sclerosis, run by Klinik Valens at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Game score of performed MindMotion GO Exergames (time frame: 3-4 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03993275, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.