Virtual Reality; Rehabilitation; Parkinson's Disease
Conditions
Brief summary
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.
Interventions
DEVICEVirtual reality-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.
DEVICETreadmill training without VR-based interaction
Treadmill training without VR-based interaction
Sponsors
Ministry of Trade, Industry & Energy(MOTIE, Korea)
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unified Parkinson's disease rating scale (UPDRS) part III | Change from Baseline UPDRS III at 4 weeks | motor domain of UPDRS, range: 0 (best) -52 (worst) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freezing of gait questionnaire | Change from Baseline Freezing of gait questionnaire at 4 weeks | range: 0 (best) -24 (worst) |
| Fear of falling | Change from Baseline fear of falling at 4 weeks | Numeric rating scale ranging from 0 (no fear) to 10 (most severe fear of falling). |
| Total number of falls during the recent 1 month | Change from Baseline total number of falls at 4 weeks | — |
| User satisfaction evaluation questionnaire | At 4weeks (after the completion of whole interventions) | — |
| Berg balance scale (BBS) | Change from Baseline BBS at 4 weeks | range: 0 (worst) -52 (best) |
| Gait parameters from gait analysis | Change from Baseline gait parameters at 4 weeks | gait speed, step length, cadence |
| Unified Parkinson's disease rating scale (UPDRS) part III | Change from Baseline UPDRS III at 8 weeks | motor domain of UPDRS, range: 0 (best) -52 (worst) |
| 10 meter walk test (10MWT) | Change from Baseline 10MWT at 4 weeks | gait speed (m/s) |
Countries
South Korea
Outcome results
None listed