Virtual Reality-based Interactive Treadmill Gait Training System for Parkinson's Disease

Study Overview
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Brief Summary
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Virtual-reality-based interactive treadmill system will be applied to the Parkinsons' disease patients who can walk (Hoehn and Yahr stage 2 to 4). Subjects will be randomly allocated to either VR-based treadmill training group or treadmill training without VR-based interaction. The training will be provided for 3 sessions (30min/session)/week for 4weeks, the total of 12 sessions. The outcomes will be measured at baseline, immediately after the completion of the intervention and 1 month after the intervention.

Official Title
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Virtual Reality-based Interactive Treadmill Gait Training System for Parkinson's Disease: A Randomized, Double-blind, Sham-controlled Pilot Study

Conditions
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Virtual Reality; Rehabilitation; Parkinson's Disease

Intervention / Treatment
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* Device: Virtual reality-based interactive treadmill training
* Device: Treadmill training without VR-based interaction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: definite or probable idiopathic Parkinson disease patient age from 18 to 80 years old H&Y stage 2 to 4 and who can walk 10 meter independently regardless of the use of gait aids Exclusion Criteria: unstable medical conditions cognitive impairments which interfere with participation in virtual-reality based training hemispatial neglect, visual disturbance, apraxia other pre-existing disease involving the central nervous system (e.g. stroke, brain tumor) requiring the continuous manual assist with touch during the treadmill training can not give a consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality-based interactive treadmill training<br>In this group, the subjects will receive virtual reality (VR)-based interactive treadmill training. During the 30-min training session, VR based interaction and feedback will be provided; the foot location will be visualized in the VR screen (semi-immersive condition), the obstacles will be seen in the screen from which subjects has to avoid, gait speed will be visualized, slopes of the treadmill will be changed according to the slope changes in VR and distractors will be added. Dual tasks will also be provided. Subjects in this group will receive a 30min/session, 3 sessions/week for 4 weeks, the total of 12 sessions of VR-based training. | Device: Virtual reality-based interactive treadmill training<br>* During the 30-min training session, VR based interaction and feedback will be provided; the foot location will be visualized in the VR screen (semi-immersive condition), the obstacles will be seen in the screen from which subjects has to avoid, gait speed will be visualized, slopes of the treadmill will be changed according to the slope changes in VR and distractors will be added. Dual tasks will also be provided. Subjects in this group will receive a 30min/session, 3 sessions/week for 4 weeks, the total of 12 sessions of VR-based training.<br>|
| Sham Comparator: Treadmill training without VR-based interaction<br>The subjects in this group will receive the treadmill gait training. Virtual reality environment will be provided during the gait training but no feedback and interaction will be provided. Subjects in this group will receive a 30min/session, 3 sessions/week for 4 weeks, the total of 12 sessions of treadmill-based training. | Device: Treadmill training without VR-based interaction<br>* Treadmill training without VR-based interaction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unified Parkinson's disease rating scale (UPDRS) part III | motor domain of UPDRS, range: 0 (best) -52 (worst) | Change from Baseline UPDRS III at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10 meter walk test (10MWT) | gait speed (m/s) | Change from Baseline 10MWT at 4 weeks | 
| 10 meter walk test (10MWT) | gait speed (m/s) | Change from Baseline 10MWT at 8 weeks | 
| Berg balance scale (BBS) | range: 0 (worst) -52 (best) | Change from Baseline BBS at 4 weeks | 
| Berg balance scale (BBS) | range: 0 (worst) -52 (best) | Change from Baseline BBS at 8 weeks | 
| Freezing of gait questionnaire | range: 0 (best) -24 (worst) | Change from Baseline Freezing of gait questionnaire at 4 weeks | 
| Freezing of gait questionnaire | range: 0 (best) -24 (worst) | Change from Baseline Freezing of gait questionnaire at 8 weeks | 
| Fear of falling | Numeric rating scale ranging from 0 (no fear) to 10 (most severe fear of falling). | Change from Baseline fear of falling at 4 weeks | 
| Fear of falling | Numeric rating scale ranging from 0 (no fear) to 10 (most severe fear of falling). | Change from Baseline fear of falling at 8 weeks | 
| Total number of falls during the recent 1 month |  | Change from Baseline total number of falls at 4 weeks | 
| Total number of falls during the recent 1 month |  | Change from Baseline total number of falls at 8 weeks | 
| User satisfaction evaluation questionnaire |  | At 4weeks (after the completion of whole interventions) | 
| Gait parameters from gait analysis | gait speed, step length, cadence | Change from Baseline gait parameters at 4 weeks | 
| Gait parameters from gait analysis | gait speed, step length, cadence | Change from Baseline gait parameters at 8 weeks | 
| Unified Parkinson's disease rating scale (UPDRS) part III | motor domain of UPDRS, range: 0 (best) -52 (worst) | Change from Baseline UPDRS III at 8 weeks |