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

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

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 Overview

• Status: Completed
• Conditions: Virtual Reality; Rehabilitation; Parkinson's Disease
• Intervention / Treatment: Device: Virtual reality-based interactive treadmill training; Device: Treadmill training without VR-based interaction

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: Virtual reality-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.
SHAM_COMPARATOR: 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.	Device: Treadmill training without VR-based interaction; Treadmill training without VR-based interaction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unified Parkinson's disease rating scale (UPDRS) part III	motor domain of UPDRS, range: 0 (best) -52 (worst)	Change from Baseline UPDRS III at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10 meter walk test (10MWT)	gait speed (m/s)	Change from Baseline 10MWT at 4 weeks
10 meter walk test (10MWT)	gait speed (m/s)	Change from Baseline 10MWT at 8 weeks
Berg balance scale (BBS)	range: 0 (worst) -52 (best)	Change from Baseline BBS at 4 weeks
Berg balance scale (BBS)	range: 0 (worst) -52 (best)	Change from Baseline BBS at 8 weeks
Freezing of gait questionnaire	range: 0 (best) -24 (worst)	Change from Baseline Freezing of gait questionnaire at 4 weeks
Freezing of gait questionnaire	range: 0 (best) -24 (worst)	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).	Change from Baseline fear of falling at 4 weeks
Fear of falling	Numeric rating scale ranging from 0 (no fear) to 10 (most severe fear of falling).	Change from Baseline fear of falling at 8 weeks
Total number of falls during the recent 1 month		Change from Baseline total number of falls at 4 weeks
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)
Gait parameters from gait analysis	gait speed, step length, cadence	Change from Baseline gait parameters at 4 weeks
Gait parameters from gait analysis	gait speed, step length, cadence	Change from Baseline gait parameters at 8 weeks
Unified Parkinson's disease rating scale (UPDRS) part III	motor domain of UPDRS, range: 0 (best) -52 (worst)	Change from Baseline UPDRS III at 8 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Ministry of Trade, Industry & Energy(MOTIE, Korea)

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2018
• Primary Completion (ACTUAL): November 11, 2019
• Study Completion (ACTUAL): November 11, 2019

Study Registration Dates

• First Submitted: September 25, 2018
• First Submitted That Met QC Criteria: September 25, 2018
• First Posted (ACTUAL): September 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 11, 2019
• Last Update Submitted That Met QC Criteria: December 9, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: B-1806/474-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No