Virtual Reality; Rehabilitation; Parkinson's Disease Clinical Trial
Official title:
Virtual Reality-based Interactive Treadmill Gait Training System for Parkinson's Disease: A Randomized, Double-blind, Sham-controlled Pilot Study
| Verified date | December 2019 |
| Source | Seoul National University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 22 |
| Est. completion date | November 11, 2019 |
| Est. primary completion date | November 11, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Hospital | Ministry of Trade, Industry & Energy(MOTIE, Korea) |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 10 meter walk test (10MWT) | gait speed (m/s) | Change from Baseline 10MWT at 4 weeks | |
| Secondary | 10 meter walk test (10MWT) | gait speed (m/s) | Change from Baseline 10MWT at 8 weeks | |
| Secondary | Berg balance scale (BBS) | range: 0 (worst) -52 (best) | Change from Baseline BBS at 4 weeks | |
| Secondary | Berg balance scale (BBS) | range: 0 (worst) -52 (best) | Change from Baseline BBS at 8 weeks | |
| Secondary | Freezing of gait questionnaire | range: 0 (best) -24 (worst) | Change from Baseline Freezing of gait questionnaire at 4 weeks | |
| Secondary | Freezing of gait questionnaire | range: 0 (best) -24 (worst) | Change from Baseline Freezing of gait questionnaire at 8 weeks | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Total number of falls during the recent 1 month | Change from Baseline total number of falls at 4 weeks | ||
| Secondary | Total number of falls during the recent 1 month | Change from Baseline total number of falls at 8 weeks | ||
| Secondary | User satisfaction evaluation questionnaire | At 4weeks (after the completion of whole interventions) | ||
| Secondary | Gait parameters from gait analysis | gait speed, step length, cadence | Change from Baseline gait parameters at 4 weeks | |
| Secondary | Gait parameters from gait analysis | gait speed, step length, cadence | Change from Baseline gait parameters at 8 weeks | |
| Secondary | 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 |