Exergames Balance Program in Neurorehabilitation

NCT03993275 | Completed FDA Device

• 1 other identifier: MindMaze
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Multiple Sclerosis; Balance Disorders

Keywords

Trunk Control; Exergames

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Change in Intrinsic Motivation during the treatment phase

  Baseline and after 3-4 weeks of training

• Montreal cognitive assessment

  Baseline and after 3-4 weeks of training.

Study Arms (2)

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 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

Interventions

MindMotion GO 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; Patients with Stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Klinik Valens: lead
• Mindmaze SA: collaborator
• KU Leuven: collaborator

Study Sites (1)

Rehazentrum Valens

Valens, Canton of St. Gallen, 7317, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 35315785 DERIVED

MeSH Terms

Conditions

Stroke; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jan Kool

  Kliniken Valens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist and Researcher, MSc

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: June 20, 2019
• Study Start: October 10, 2018
• Primary Completion: January 15, 2020
• Study Completion: January 15, 2020
• Last Updated: May 13, 2020

Record last verified: 2020-05

Locations

CH (1)