Clinical trial NCT03686462: Virtual Reality-based Interactive Treadmill Gait Training System for Parkinson's Disease
Official title: Virtual Reality-based Interactive Treadmill Gait Training System for Parkinson's Disease: A Randomized, Double-blind, Sham-controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Virtual Reality; Rehabilitation; Parkinson's Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Trade, Industry & Energy(MOTIE, Korea)
First posted: 2018-09-27
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Unified Parkinson's disease rating scale (UPDRS) part III
timeFrame: Change from Baseline UPDRS III at 4 weeks
Secondary outcomes:
measure: 10 meter walk test (10MWT)
timeFrame: Change from Baseline 10MWT at 4 weeks
measure: 10 meter walk test (10MWT)
timeFrame: Change from Baseline 10MWT at 8 weeks
measure: Berg balance scale (BBS)
timeFrame: Change from Baseline BBS at 4 weeks
measure: Berg balance scale (BBS)
timeFrame: Change from Baseline BBS at 8 weeks
measure: Freezing of gait questionnaire
timeFrame: Change from Baseline Freezing of gait questionnaire at 4 weeks
measure: Freezing of gait questionnaire
timeFrame: Change from Baseline Freezing of gait questionnaire at 8 weeks
measure: Fear of falling
timeFrame: Change from Baseline fear of falling at 4 weeks
measure: Fear of falling
timeFrame: Change from Baseline fear of falling at 8 weeks
measure: Total number of falls during the recent 1 month
timeFrame: Change from Baseline total number of falls at 4 weeks
measure: Total number of falls during the recent 1 month
timeFrame: Change from Baseline total number of falls at 8 weeks
measure: User satisfaction evaluation questionnaire
timeFrame: At 4weeks (after the completion of whole interventions)
measure: Gait parameters from gait analysis
timeFrame: Change from Baseline gait parameters at 4 weeks
measure: Gait parameters from gait analysis
timeFrame: Change from Baseline gait parameters at 8 weeks
measure: Unified Parkinson's disease rating scale (UPDRS) part III
timeFrame: Change from Baseline UPDRS III at 8 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References: