Virtual Reality-based Interactive Treadmill Gait Training System for Parkinson's Disease

Not Applicable

Completed

• Conditions: Virtual Reality; Rehabilitation; Parkinson's Disease

• Registration Number: NCT03686462
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-25
• Study First Submitted QC: 2018-09-25
• Study First Posted: 2018-09-27
• Study Start: 2018-10-15
• Primary Completion: 2019-11-11
• Study Completion: 2019-11-11
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-09
• Last Update Posted: 2019-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Fear of falling	Change from Baseline fear of falling at 8 weeks	Numeric rating scale ranging from 0 (no fear) to 10 (most severe fear of falling).
10 meter walk test (10MWT)	Change from Baseline 10MWT at 8 weeks	gait speed (m/s)
Freezing of gait questionnaire	Change from Baseline Freezing of gait questionnaire at 8 weeks	range: 0 (best) -24 (worst)
Gait parameters from gait analysis	Change from Baseline gait parameters at 8 weeks	gait speed, step length, cadence
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)
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)
Berg balance scale (BBS)	Change from Baseline BBS at 8 weeks	range: 0 (worst) -52 (best)

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of