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

Seoul National University Hospital22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Virtual Reality; Rehabilitation; Parkinson's Disease

Interventions

Virtual reality-based interactive treadmill trainingDEVICE

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 interactionDEVICE

Treadmill training without VR-based interaction

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

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

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

Time frame: Change from Baseline UPDRS III at 4 weeks

Secondary Outcomes

10 meter walk test (10MWT)

gait speed (m/s)

Time frame: Change from Baseline 10MWT at 4 weeks

10 meter walk test (10MWT)

gait speed (m/s)

Time frame: Change from Baseline 10MWT at 8 weeks

Berg balance scale (BBS)

range: 0 (worst) -52 (best)

Time frame: Change from Baseline BBS at 4 weeks

Berg balance scale (BBS)

range: 0 (worst) -52 (best)

Time frame: Change from Baseline BBS at 8 weeks

Freezing of gait questionnaire

range: 0 (best) -24 (worst)

Time frame: Change from Baseline Freezing of gait questionnaire at 4 weeks

Freezing of gait questionnaire

range: 0 (best) -24 (worst)

Time frame: Change from Baseline Freezing of gait questionnaire at 8 weeks

Fear of falling

Numeric rating scale ranging from 0 (no fear) to 10 (most severe fear of falling).

Time frame: Change from Baseline fear of falling at 4 weeks

Fear of falling

Data from ClinicalTrials.gov

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