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

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ClinicalTrials.gov Identifier: NCT03686462
Recruitment Status : Recruiting
First Posted : September 27, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
Ministry of Trade, Industry & Energy(MOTIE, Korea)
Information provided by (Responsible Party):
Won-Seok Kim, Seoul National University Bundang 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.

Condition or disease Intervention/treatment Phase
Virtual Reality; Rehabilitation; Parkinson's Disease Device: Virtual reality-based interactive treadmill training Device: Treadmill training without VR-based interaction Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Virtual Reality-based Interactive Treadmill Gait Training System for Parkinson's Disease: A Randomized, Double-blind, Sham-controlled Pilot Study
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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




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


Secondary Outcome Measures :
  1. 10 meter walk test (10MWT) [ Time Frame: Change from Baseline 10MWT at 4 weeks ]
    gait speed (m/s)

  2. 10 meter walk test (10MWT) [ Time Frame: Change from Baseline 10MWT at 8 weeks ]
    gait speed (m/s)

  3. Berg balance scale (BBS) [ Time Frame: Change from Baseline BBS at 4 weeks ]
    range: 0 (worst) -52 (best)

  4. Berg balance scale (BBS) [ Time Frame: Change from Baseline BBS at 8 weeks ]
    range: 0 (worst) -52 (best)

  5. Freezing of gait questionnaire [ Time Frame: Change from Baseline Freezing of gait questionnaire at 4 weeks ]
    range: 0 (best) -24 (worst)

  6. Freezing of gait questionnaire [ Time Frame: Change from Baseline Freezing of gait questionnaire at 8 weeks ]
    range: 0 (best) -24 (worst)

  7. Fear of falling [ Time Frame: Change from Baseline fear of falling at 4 weeks ]
    Numeric rating scale ranging from 0 (no fear) to 10 (most severe fear of falling).

  8. Fear of falling [ Time Frame: Change from Baseline fear of falling at 8 weeks ]
    Numeric rating scale ranging from 0 (no fear) to 10 (most severe fear of falling).

  9. Total number of falls during the recent 1 month [ Time Frame: Change from Baseline total number of falls at 4 weeks ]
  10. Total number of falls during the recent 1 month [ Time Frame: Change from Baseline total number of falls at 8 weeks ]
  11. User satisfaction evaluation questionnaire [ Time Frame: At 4weeks (after the completion of whole interventions) ]
  12. Gait parameters from gait analysis [ Time Frame: Change from Baseline gait parameters at 4 weeks ]
    gait speed, step length, cadence

  13. Gait parameters from gait analysis [ Time Frame: Change from Baseline gait parameters at 8 weeks ]
    gait speed, step length, cadence

  14. Unified Parkinson's disease rating scale (UPDRS) part III [ Time Frame: Change from Baseline UPDRS III at 8 weeks ]
    motor domain of UPDRS, range: 0 (best) -52 (worst)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686462


Contacts
Contact: Won-Seok Kim, MD, PhD +82317877735 wondol77@gmail.com

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
Contact: Won-Seok Kim, MD    317877735      
Sponsors and Collaborators
Seoul National University Hospital
Ministry of Trade, Industry & Energy(MOTIE, Korea)

Responsible Party: Won-Seok Kim, Assistant professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03686462     History of Changes
Other Study ID Numbers: B-1806/474-002
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases