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

Primary Purpose

Virtual Reality; Rehabilitation; Parkinson's Disease

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Virtual reality-based interactive treadmill training

Treadmill training without VR-based interaction

About this trial

This is an interventional treatment trial for Virtual Reality; Rehabilitation; Parkinson's Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Virtual reality-based interactive treadmill training

Treadmill training without VR-based interaction

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

10 meter walk test (10MWT)

gait speed (m/s)

10 meter walk test (10MWT)

gait speed (m/s)

Berg balance scale (BBS)

range: 0 (worst) -52 (best)

Berg balance scale (BBS)

range: 0 (worst) -52 (best)

Freezing of gait questionnaire

range: 0 (best) -24 (worst)

Freezing of gait questionnaire

range: 0 (best) -24 (worst)

Fear of falling

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

Fear of falling

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

Total number of falls during the recent 1 month

User satisfaction evaluation questionnaire

Gait parameters from gait analysis

gait speed, step length, cadence

Gait parameters from gait analysis

gait speed, step length, cadence

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

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

Full Information

NCT ID

NCT03686462

First Posted

September 25, 2018

Last Updated

December 9, 2019

Sponsor

Seoul National University Hospital

Collaborators

Ministry of Trade, Industry & Energy(MOTIE, Korea)

1. Study Identification

Unique Protocol Identification Number

NCT03686462

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

October 15, 2018 (Actual)

Primary Completion Date

November 11, 2019 (Actual)

Study Completion Date

November 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

Collaborators

Ministry of Trade, Industry & Energy(MOTIE, Korea)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Virtual Reality; Rehabilitation; Parkinson's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Virtual reality-based interactive treadmill training

Arm Type

Experimental

Arm Description

Arm Title

Treadmill training without VR-based interaction

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Virtual reality-based interactive treadmill training

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Treadmill training without VR-based interaction

Intervention Description

Treadmill training without VR-based interaction

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Change from Baseline UPDRS III at 4 weeks

Secondary Outcome Measure Information:

Title

10 meter walk test (10MWT)

Description

gait speed (m/s)

Time Frame

Change from Baseline 10MWT at 4 weeks

Title

10 meter walk test (10MWT)

Description

gait speed (m/s)

Time Frame

Change from Baseline 10MWT at 8 weeks

Title

Berg balance scale (BBS)

Description

range: 0 (worst) -52 (best)

Time Frame

Change from Baseline BBS at 4 weeks

Title

Berg balance scale (BBS)

Description

range: 0 (worst) -52 (best)

Time Frame

Change from Baseline BBS at 8 weeks

Title

Freezing of gait questionnaire

Description

range: 0 (best) -24 (worst)

Time Frame

Change from Baseline Freezing of gait questionnaire at 4 weeks

Title

Freezing of gait questionnaire

Description

range: 0 (best) -24 (worst)

Time Frame

Change from Baseline Freezing of gait questionnaire at 8 weeks

Title

Fear of falling

Description

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

Title

Fear of falling

Description

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

Time Frame

Change from Baseline fear of falling at 8 weeks

Title

Total number of falls during the recent 1 month

Time Frame

Change from Baseline total number of falls at 4 weeks

Title

Total number of falls during the recent 1 month

Time Frame

Change from Baseline total number of falls at 8 weeks

Title

User satisfaction evaluation questionnaire

Time Frame

At 4weeks (after the completion of whole interventions)

Title

Gait parameters from gait analysis

Description

gait speed, step length, cadence

Time Frame

Change from Baseline gait parameters at 4 weeks

Title

Gait parameters from gait analysis

Description

gait speed, step length, cadence

Time Frame

Change from Baseline gait parameters at 8 weeks

Title

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

Description

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

Time Frame

Change from Baseline UPDRS III at 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Seoul National University Bundang Hospital

City

Seongnam-si

State/Province

Gyeonggi-do

ZIP/Postal Code

13620

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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