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

June 30, 2022 updated by: Fettah Saygılı, Gazi University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Other: 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.
Active Comparator: Conventional Training
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Unified Parkinson's Disease Rating Scale (UPDRS-III)-Baseline
Time Frame: Assessment will be conducted before intervention
The severity of motor symptoms is evaluated with 13 items in UPDRS-III. Items are scored between 0 and 4; 0 = no impairment, 4 = severe impairment. Higher scores indicate more serious impairment
Assessment will be conducted before intervention
Unified Parkinson's Disease Rating Scale (UPDRS-III)-Post Intervention
Time Frame: Assessment will be conducted immediately after the intervention
The severity of motor symptoms is evaluated with 13 items in UPDRS-III. Items are scored between 0 and 4; 0 = no impairment, 4 = severe impairment. Higher scores indicate more serious impairment
Assessment will be conducted immediately after the intervention
Hoehn and Yahr Staging Scale -Baseline
Time Frame: Assessment will be conducted before intervention
H&Y defines individuals with PD in 5 different clinical stages according to their functional disability status and clinical findings. As the stage of H&Y increases, the functional disability status of patients also increases
Assessment will be conducted before intervention
Hoehn and Yahr Staging Scale -Post Intervention
Time Frame: Assessment will be conducted immediately after the intervention
H&Y defines individuals with PD in 5 different clinical stages according to their functional disability status and clinical findings. As the stage of H&Y increases, the functional disability status of patients also increases
Assessment will be conducted immediately after the intervention
Huber 360° Evolution System-baseline
Time Frame: Assessment will be conducted before intervention
Static and dynamic standing balance was evaluated with the Huber 360° Evolution System(LPG Systems, Valence, France), which objectively evaluated postural sway and limits of stability. Stability test and stability limit test were performed with the system. The stability test was performed by recording the amount of sway of the center of pressure (CoP) under standing on double-leg and standing on single-leg conditions. The test was performed under eyes open and eyes closed conditions. The lower values obtained as a result of the test means that the amount of sway is low and the postural stability is better. In the limits of stability test, while on standing and with fixed feet position patients are asked to shift their weight in a total of eight directions according to the trigonometric coordinate system. The high values obtained as a result of the test means that the amount of CoP sway is high and the stability limits of the patient is good.
Assessment will be conducted before intervention
Huber 360° Evolution System-Post Intervention
Time Frame: Assessment will be conducted immediately after the intervention
Static and dynamic standing balance was evaluated with the Huber 360° Evolution System(LPG Systems, Valence, France), which objectively evaluated postural sway and limits of stability. Stability test and stability limit test were performed with the system. The stability test was performed by recording the amount of sway of the center of pressure (CoP) under standing on double-leg and standing on single-leg conditions. The test was performed under eyes open and eyes closed conditions. The lower values obtained as a result of the test means that the amount of sway is low and the postural stability is better. In the limits of stability test, while on standing and with fixed feet position patients are asked to shift their weight in a total of eight directions according to the trigonometric coordinate system. The high values obtained as a result of the test means that the amount of CoP sway is high and the stability limits of the patient is good.
Assessment will be conducted immediately after the intervention
Berg Balance Scale (BBS)-Baseline
Time Frame: Assessment will be conducted before intervention
Functional balance was evaluated with BBS . It consists of 14 functional activities that evaluate the static and proactive balance, in which the individual is observed directly by the evaluator in terms of desired performance. Each item is scored between 0 (inability to perform the activity) and 4 (doing the activity completely independently) according to the performance of the individual to perform the desired functional activity according to the time and distance conditions of the test. BBS is scored between 0 and 56, and higher test scores mean that the individual's balance is better
Assessment will be conducted before intervention
Berg Balance Scale-Post Intervention
Time Frame: Assessment will be conducted immediately after the intervention
Functional balance was evaluated with BBS . It consists of 14 functional activities that evaluate the static and proactive balance, in which the individual is observed directly by the evaluator in terms of desired performance. Each item is scored between 0 (inability to perform the activity) and 4 (doing the activity completely independently) according to the performance of the individual to perform the desired functional activity according to the time and distance conditions of the test. BBS is scored between 0 and 56, and higher test scores mean that the individual's balance is better
Assessment will be conducted immediately after the intervention
Activities-specific Balance Confidence Scale (ABC) -Baseline
Time Frame: Assessment will be conducted before intervention
The level of confidence that an individual feels during activities of daily living related to balance was evaluated with ABC. With 16 questions asked directly to the individual by the evaluator, the level of confidence ranged from 0% (totally unsafe) to 100% (totally safe). The total score is determined by summing the values of 16 items and dividing by 16, which is the total number of question items. A total score between 0 and 49 indicates a low functional level, between 50 and 80 indicates a moderate functional level, and between 81 and 100 indicates a high functional level.
Assessment will be conducted before intervention
Activities-specific Balance Confidence Scale (ABC) -Post Intervention
Time Frame: Assessment will be conducted immediately after the intervention
The level of confidence that an individual feels during activities of daily living related to balance was evaluated with ABC. With 16 questions asked directly to the individual by the evaluator, the level of confidence ranged from 0% (totally unsafe) to 100% (totally safe). The total score is determined by summing the values of 16 items and dividing by 16, which is the total number of question items. A total score between 0 and 49 indicates a low functional level, between 50 and 80 indicates a moderate functional level, and between 81 and 100 indicates a high functional level.
Assessment will be conducted immediately after the intervention
Spatio-temporal gait analysis -Baseline
Time Frame: Assessment will be conducted before intervention
In the evaluation of spatio-temporal parameters of gait, patients were asked to walk on the platform of the C-Mill VR+ device for 3 minutes at the highest confident speed they felt safe. Right-left step lengths, stride length, and step width were recorded in meters from the spatial parameters, while the right-left stance phase duration, right-left swing phase duration and total double support phase duration were recorded in seconds for the evaluation of temporal parameters. Additionally, walking speed and distance were recorded during these analyses.
Assessment will be conducted before intervention
Spatio-temporal gait analysis -Post Intervention
Time Frame: Assessment will be conducted immediately after the intervention
In the evaluation of spatio-temporal parameters of gait, patients were asked to walk on the platform of the C-Mill VR+ device for 3 minutes at the highest confident speed they felt safe. Right-left step lengths, stride length, and step width were recorded in meters from the spatial parameters, while the right-left stance phase duration, right-left swing phase duration and total double support phase duration were recorded in seconds for the evaluation of temporal parameters. Additionally, walking speed and distance were recorded during these analyses.
Assessment will be conducted immediately after the intervention
Timed Up and Go Test (TUG)- Baseline
Time Frame: Assessment will be conducted before intervention
Functional mobility was assessed with TUG. The patient was asked to stand up from the chair with the "walk" command, walk 3 m, turn around and sit back on the chair. The test was carried out on a flat 3 meter surface. In addition, TUG has been shown to be highly reliable in PD.
Assessment will be conducted before intervention
Timed Up and Go Test (TUG)- Post Intervention
Time Frame: Assessment will be conducted immediately after the intervention
Functional mobility was assessed with TUG. The patient was asked to stand up from the chair with the "walk" command, walk 3 m, turn around and sit back on the chair. The test was carried out on a flat 3 meter surface. In addition, TUG has been shown to be highly reliable in PD.
Assessment will be conducted immediately after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1-PD C-Mill

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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