Clinical trial NCT03993275: Exergames Balance Program in Neurorehabilitation
Official title: Exergames Balance Program in Neurorehabilitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Multiple Sclerosis
Balance Disorders
Keywords: Trunk Control
Exergames
Lead sponsor: Klinik Valens
Sponsor class: OTHER
Collaborators: name: Mindmaze SA
name: KU Leuven
First posted: 2019-06-20
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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. 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Game score of performed MindMotion GO Exergames
timeFrame: 3-4 weeks
measure: Change in Balance (Berg Balance Scale)
timeFrame: Baseline, weekly, and after 3-4 weeks of training
measure: Change in trunk control and sitting Balance (Trunk Impairment Scale)
timeFrame: Baseline and after 3-4 weeks of training
measure: Change in mobility
timeFrame: Baseline and after 3-4 weeks of training
measure: Change in dynamic balance during gait
timeFrame: Baseline and after 3-4 weeks of training
measure: Change in the perceived Walking ability
timeFrame: Baseline and after 3-4 weeks of training
measure: Subjective difficulty of performed MindMotion GO Exerames
timeFrame: 3-4 weeks
Secondary outcomes:
measure: Change in Intrinsic Motivation during the treatment phase
timeFrame: Baseline and after 3-4 weeks of training
measure: Montreal cognitive assessment
timeFrame: Baseline and after 3-4 weeks of training.
Other outcomes:
Locations:
city: Valens
country: Switzerland
facility: Rehazentrum Valens
state: SG
Study officials:
affiliation: Kliniken Valens
name: Jan Kool
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.