Exergames Balance Program in Neurorehabilitation

NCT ID: NCT03993275

Last Updated: 2020-05-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 84 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-10
• Study Completion Date: 2020-01-15

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.

Conditions

Stroke; Multiple Sclerosis; Balance Disorders

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

MindMotion GO

Intervention Type: DEVICE

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.

MindMotion GO

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mindmaze SA

INDUSTRY

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: collaborator

Klinik Valens

OTHER

Sponsor Role: lead

Responsible Party

Evelyne Wiskerke

Physiotherapist and Researcher, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan Kool

Role: PRINCIPAL_INVESTIGATOR

Kliniken Valens

Locations

Rehazentrum Valens

Valens, Canton of St. Gallen, Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 35315785 (View on PubMed)

Other Identifiers

MindMaze

Identifier Type: -

Identifier Source: org_study_id