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

Not Applicable

Completed

• Conditions: Virtual Reality; Rehabilitation; Parkinson's Disease
• Interventions: Device: Virtual reality-based interactive treadmill training; Device: Treadmill training without VR-based interaction

• 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

Arm && Interventions

Group	Intervention	Description
Virtual reality-based interactive treadmill training	Virtual reality-based interactive treadmill training	In this group, the subjects will receive virtual reality (VR)-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.
Treadmill training without VR-based interaction	Treadmill training without VR-based interaction	The subjects in this group will receive the treadmill gait training. Virtual reality environment will be provided during the gait training but no feedback and interaction will be provided. Subjects in this group will receive a 30min/session, 3 sessions/week for 4 weeks, the total of 12 sessions of treadmill-based training.

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
Freezing of gait questionnaire	Change from Baseline Freezing of gait questionnaire at 8 weeks	range: 0 (best) -24 (worst)
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).
Berg balance scale (BBS)	Change from Baseline BBS at 8 weeks	range: 0 (worst) -52 (best)
10 meter walk test (10MWT)	Change from Baseline 10MWT at 8 weeks	gait speed (m/s)
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)

Trial Locations

Locations (1)

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