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Completed

NCT Number: NCT03686462

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

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.

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Key information

Conditions

Virtual Reality; Rehabilitation; Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality-based interactive treadmill training

Device

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

Device

Treadmill training without VR-based interaction

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 27, 2018
Registry last updated
Dec 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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