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| Name | Class |
|---|---|
| Ministry of Trade, Industry & Energy(MOTIE, Korea) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality-based interactive treadmill training | Experimental | 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. |
|
| Treadmill training without VR-based interaction | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality-based interactive treadmill training | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
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| Treadmill training without VR-based interaction | Device | Treadmill training without VR-based interaction |
|
| 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 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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