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

Seoul National University Hospital1 site in 1 country22 target enrollmentOctober 15, 2018

ConditionsVirtual Reality; Rehabilitation; Parkinson's Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Virtual Reality; Rehabilitation; Parkinson's Disease
Sponsor: Seoul National University Hospital
Enrollment: 22
Locations: 1
Primary Endpoint: Unified Parkinson's disease rating scale (UPDRS) part III
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 15, 2018

End Date

November 11, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Won-Seok Kim

Assistant professor

Seoul National University Bundang Hospital

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

Outcomes

Primary Outcomes

Unified Parkinson's disease rating scale (UPDRS) part III

Time Frame: Change from Baseline UPDRS III at 4 weeks

motor domain of UPDRS, range: 0 (best) -52 (worst)

Secondary Outcomes

10 meter walk test (10MWT)(Change from Baseline 10MWT at 8 weeks)
User satisfaction evaluation questionnaire(At 4weeks (after the completion of whole interventions))
Berg balance scale (BBS)(Change from Baseline BBS at 8 weeks)
Freezing of gait questionnaire(Change from Baseline Freezing of gait questionnaire at 8 weeks)
Fear of falling(Change from Baseline fear of falling at 8 weeks)
Unified Parkinson's disease rating scale (UPDRS) part III(Change from Baseline UPDRS III at 8 weeks)
Gait parameters from gait analysis(Change from Baseline gait parameters at 8 weeks)
Total number of falls during the recent 1 month(Change from Baseline total number of falls at 8 weeks)