The Effects of Augmented and Virtual Reality Gait Training on Patients With Parkinson's Disease

NCT ID: NCT05439967

Last Updated: 2022-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2021-12-01

Brief Summary

In Parkinson's Disease (PD) rehabilitation, the treadmill is used both in aerobic training and in gait training, as it provides more walking distance and can include body weight supported systems. It has been reported that the C-Mill VR+ device, which is a treadmill system with augmented and virtual reality (VR) technology, improves gait adaptation and reduces the risk of falling in individuals with early to mid-stage PD. Several publications augmented reality (AR) and VR applications in PD was focused on balance activities that do not include ambulation. In other studies in the literature, it was stated that further research are needed to better understand the effects of VR gait training on gait and balance in PD. It was also stated in these studies that the effects of VR gait training should be examined with more objective measurement methods. As a result, it is seen that there is a need for studies examining the effects of augmented and virtual reality trainings in PD with objective measurement methods. Therefore, our study aimed to examine the effects of AR and VR gait training on gait and balance in individuals with early to mid-stage PD.

Detailed Description

Participants included in the study will randomly divide were randomly divided into 2 groups as intervention (IG, n=15) and control (CG, n=15). IG was given augmented and virtual reality gait training together with conventional training (CT). CG was given CT only. The training was applied 3 days per week for 6 weeks in both groups. All evaluations will be made by the same physiotherapist by meeting with participants face to face. Inclusion in the research will be on a voluntary basis. As outcome measures, motor symptoms, balance, balance confidence and gait analyses were performed before and after intervention.

Conditions

Parkinson Disease

Study Design

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

Study Groups

Intervention

Group Type: EXPERIMENTAL

Augmented and Virtual Reality Gait and balanceTraining

Intervention Type: OTHER

C-Mill VR+ device used for training. The training was carried out 3 days a week for 6 weeks, with each exercise session lasting approximately 1.5 hours, accompanied by a physiotherapist. Training started with conventional exercises, continued with C-Mill VR+ training, and ended with stretching and relaxation exercises. The patients in the intervention group were applied the exercises with the same principles with conventional training, except the exercises performed in standing and walking. Patients performed 10 exercises in AR and VR gait training for 4 minutes and resting the individuals by sitting for 1 minute between exercises.

Conventional Training

Group Type: ACTIVE_COMPARATOR

Conventional Training

Intervention Type: OTHER

Conventional training was applied to the patients in the control group. Conventional training was planned taking into account the following goals: increasing mobility by improving the impaired kinesthetic sensation; improving axial rotation, coordination, flexibility of soft tissues, mobility in and out of bed; increasing body image perception by improving upright and proper posture; and improving balance and gait. The training was applied 3 days a week for 6 weeks, with each exercise session lasting 40-50 minutes, accompanied by a physiotherapist. Each of the exercises was done in 2 sets of 10 repetitions. In gait training, each exercise was performed for 4 minutes.

Interventions

Augmented and Virtual Reality Gait and balanceTraining

C-Mill VR+ device used for training. The training was carried out 3 days a week for 6 weeks, with each exercise session lasting approximately 1.5 hours, accompanied by a physiotherapist. Training started with conventional exercises, continued with C-Mill VR+ training, and ended with stretching and relaxation exercises. The patients in the intervention group were applied the exercises with the same principles with conventional training, except the exercises performed in standing and walking. Patients performed 10 exercises in AR and VR gait training for 4 minutes and resting the individuals by sitting for 1 minute between exercises.

Intervention Type: OTHER

Conventional Training

Conventional training was applied to the patients in the control group. Conventional training was planned taking into account the following goals: increasing mobility by improving the impaired kinesthetic sensation; improving axial rotation, coordination, flexibility of soft tissues, mobility in and out of bed; increasing body image perception by improving upright and proper posture; and improving balance and gait. The training was applied 3 days a week for 6 weeks, with each exercise session lasting 40-50 minutes, accompanied by a physiotherapist. Each of the exercises was done in 2 sets of 10 repetitions. In gait training, each exercise was performed for 4 minutes.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• being diagnosed with Parkinson's Disease by a specialist physician
• being grade 1-3 on the Hoehn and Yahr Staging Scale
• being 40 years or older; and
• individuals agreed to be included in the study after adequate information was given about the study

Exclusion Criteria

• People who standardised Mini-Mental State Examination score < 24
• Having any cardiovascular, vestibular, musculoskeletal, or additional neurological disease.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

Fettah Saygılı

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

1-PD C-Mill

Identifier Type: -

Identifier Source: org_study_id