Stroke Clinical Trial
Official title:
Exergames Balance Program in Neurorehabilitation
NCT number | NCT03993275 |
Other study ID # | MindMaze |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 10, 2018 |
Est. completion date | January 15, 2020 |
Verified date | May 2020 |
Source | Klinik Valens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 84 |
Est. completion date | January 15, 2020 |
Est. primary completion date | January 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Switzerland | Rehazentrum Valens | Valens | SG |
Lead Sponsor | Collaborator |
---|---|
Klinik Valens | KU Leuven, Mindmaze SA |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 3-4 weeks | |
Primary | 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. | Baseline, weekly, and after 3-4 weeks of training | |
Primary | 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. | Baseline and after 3-4 weeks of training | |
Primary | 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. | Baseline and after 3-4 weeks of training | |
Primary | 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. | Baseline and after 3-4 weeks of training | |
Primary | 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. | Baseline and after 3-4 weeks of training | |
Primary | 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. | 3-4 weeks | |
Secondary | Change in Intrinsic Motivation during the treatment phase | Intrinsic motivation inventory assesses motivation and satisfaction with therapy. | Baseline and after 3-4 weeks of training | |
Secondary | 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. | Baseline and after 3-4 weeks of training. |
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