Comparison of Two Different Virtual Reality Methods in Patients With Multiple Sclerosis

NCT ID: NCT03436927

Last Updated: 2018-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-15
• Study Completion Date: 2017-07-15

Brief Summary

As a chronic, autoimmune, inflammatory disease of the central nervous system, Multiple Sclerosis (MS) is a neurologic problem which the most frequent cause of disability in young adults. Fatigue, pain, spasticity, muscle weakness, depression, as well as balance and gait disorders are amongst the symptoms of MS. Balance disorders and the falls caused by them are the most frequent problems which result in disability of MS patients, with 75% of all patients being affected during the course of disease. When considering previous studies carried out on physiotherapy and rehabilitation practices in the light of balance disorders and other related problems faced by MS patients, it can been that various physiotherapeutic approaches are applied with varying follow-up times and in the form of hospital sessions, home sessions, or group training. Posture and balance problems in MS patients are tried to be solved through long-lasting treatment sessions using traditional methods of physiotherapy, where less patient participation is observed. Fatigue, psychological impairment, and insufficient motivation are other aspects which influence the success of treatment and which need to be addressed in MS patients. In contrast to traditional methods of physiotherapy applied in form of long-lasting treatment sessions, technology-supported rehabilitation approaches have emerged in recent years. It can be seen that different systems have started to be employed in the physiotherapy of many chronic diseases, either alone or in company with traditional methods. Even though the clinical use of these systems is becoming widespread, there are certain gaps in terms of the systems' impacts, comparative advantages, or cost effectiveness. Keeping this in mind, the purpose of this study is to investigate and compare the impacts of 'Nintendo Wii Fit' and 'Balance Trainer', as two of the technologic methods with therapeutic impact which have started to be used for different diagnosis groups in recent years, on the balance and posture parameters of MS patients, with the ultimate aim to introduce a whole new point of view to traditional physiotherapy and rehabilitation studies.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Nintendo Wii Fit

Participants in the Nintendo Wii group were included to exercise program that consisted of 16 individual PT-supervised sessions (two 60-minute sessions/week), which were prepared to improve balance. Each session started with 10 minutes of non-resistance cycling work for warm-up.

Group Type: EXPERIMENTAL

Nintendo Wii Fit Balance exercises

Intervention Type: OTHER

Nintendo Wii Fit' training protocol consisted of 'Penguin Slide', 'Table Tilt', 'Ski Slalom', 'Heading' and 'Balance Bubble' games that selected from the Wii Fit Plus balance games section

Balance Trainer

Participants in the Balance Trainer group were included to exercise program that consisted of 16 individual PT-supervised sessions (two 60-minute sessions/week), which were prepared to improve balance. Each session started with 10 minutes of non-resistance cycling work for warm-up.

Group Type: EXPERIMENTAL

Balance Trainer Balance Exercises

Intervention Type: OTHER

Balance Trainer' training protocol consisted of 'Collect Apples', 'Outline', 'Paddle War' and 'Evaluation of Movement' games which were included in the device software and allowed the patients to done balance exercises in different directions.

Control

Patients in the 'Group III-control group' were included in the waiting list until the end of the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nintendo Wii Fit Balance exercises

Nintendo Wii Fit' training protocol consisted of 'Penguin Slide', 'Table Tilt', 'Ski Slalom', 'Heading' and 'Balance Bubble' games that selected from the Wii Fit Plus balance games section

Intervention Type: OTHER

Balance Trainer Balance Exercises

Balance Trainer' training protocol consisted of 'Collect Apples', 'Outline', 'Paddle War' and 'Evaluation of Movement' games which were included in the device software and allowed the patients to done balance exercises in different directions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• . Participants who were ambulatory and volunteer to participate to the study, in a stable phase of the disease, without relapses or worsening in the last 3 months, with an EDSS between 2.5-6 and aged between 25 to 60 years

Exclusion Criteria

• physical activity more than 150 minutes per week, were pregnant, had blurred vision, had psychiatric problems, or severe cognitive impairment.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: collaborator

Biruni University

OTHER

Sponsor Role: lead

Responsible Party

Yonca Zenginler

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

YZenginler

Identifier Type: -

Identifier Source: org_study_id