Virtual Reality; Rehabilitation; Parkinson's DiseaseNCT03686462

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

A study testing Virtual reality-based interactive treadmill training and Treadmill training without VR-based interaction in people with Virtual Reality; Rehabilitation; Parkinson's Disease, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Virtual Reality; Rehabilitation; Parkinson's Disease
What is being tested?: Virtual reality-based interactive treadmill training and Treadmill training without VR-based interaction
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 1 siteSouth Korea
Study dates: 15 Oct 2018to 11 Nov 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620

Other trials in South Korea

About this study

Official title: 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.

Conditions: Virtual Reality; Rehabilitation; Parkinson's Disease
Being tested: Virtual reality-based interactive treadmill training, Treadmill training without VR-based interaction
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03686462
Study group	Role	What they receive
Virtual reality-based interactive treadmill training	Experimental	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. Receives: Device: Virtual reality-based interactive treadmill training
Treadmill training without VR-based interaction	Sham comparator	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. Receives: Device: Treadmill training without VR-based interaction

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (14)

10 meter walk test (10MWT)
gait speed (m/s)
Measured: Change from Baseline 10MWT at 4 weeks
10 meter walk test (10MWT)
gait speed (m/s)
Measured: Change from Baseline 10MWT at 8 weeks
Berg balance scale (BBS)
range: 0 (worst) -52 (best)
Measured: Change from Baseline BBS at 4 weeks
Berg balance scale (BBS)
range: 0 (worst) -52 (best)
Measured: Change from Baseline BBS at 8 weeks
Freezing of gait questionnaire
range: 0 (best) -24 (worst)
Measured: Change from Baseline Freezing of gait questionnaire at 4 weeks
Freezing of gait questionnaire
range: 0 (best) -24 (worst)
Measured: 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).
Measured: 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).
Measured: Change from Baseline fear of falling at 8 weeks
Total number of falls during the recent 1 month
Measured: Change from Baseline total number of falls at 4 weeks
Total number of falls during the recent 1 month
Measured: Change from Baseline total number of falls at 8 weeks
User satisfaction evaluation questionnaire
Measured: At 4weeks (after the completion of whole interventions)
Gait parameters from gait analysis
gait speed, step length, cadence
Measured: Change from Baseline gait parameters at 4 weeks
Gait parameters from gait analysis
gait speed, step length, cadence
Measured: 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)
Measured: Change from Baseline UPDRS III at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 201811 Nov 2019

First posted27 Sep 2018
Study start15 Oct 2018
Primary completion11 Nov 2019
Study completion11 Nov 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Virtual Reality; Rehabilitation; Parkinson's DiseaseStudies of the same condition, open and under way.
More trials run by Seoul National University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03686462
Sponsor's protocol ID: B-1806/474-002
Status last verified: Dec 2019
First submitted: 25 Sep 2018
Last updated: 11 Dec 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Cognitive-Based Balance Rehabilitation in Parkinson's Disease: Virtual Reality vs. Dual Task
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Comparative Effects of Virtual Reality and Proprioceptive Neuromuscular Facilitation in Patients With Parkinson's Disease
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All Virtual Reality; Rehabilitation; Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Virtual Reality-based Interactive Treadmill Gait Training System for Parkinson's Disease: A Randomized, Double-blind, Sham-controlled Pilot Study
ClinicalTrials.gov ID: NCT03686462
Acronym / sponsor ID: B-1806/474-002
Conditions: Virtual Reality; Rehabilitation; Parkinson's Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Collaborators: Ministry of Trade, Industry & Energy(MOTIE, Korea)
Study start: 15 Oct 2018 (actual)
Primary completion: 11 Nov 2019 (actual)
Study completion: 11 Nov 2019 (actual)
First posted: 27 Sep 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Virtual reality-based interactive treadmill training	Experimental	Device: Virtual reality-based interactive treadmill trainingIn 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.
Treadmill training without VR-based interaction	Sham comparator	Device: Treadmill training without VR-based interactionThe 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.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Virtual reality-based interactive treadmill trainingDuring 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
Treadmill training without VR-based interactionTreadmill training without VR-based interaction	Device	Treadmill training without VR-based interaction

Primary outcome

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)

14 secondary outcomes

10 meter walk test (10MWT)
Time frame: Change from Baseline 10MWT at 4 weeks
10 meter walk test (10MWT)
Time frame: Change from Baseline 10MWT at 8 weeks
Berg balance scale (BBS)
Time frame: Change from Baseline BBS at 4 weeks
Berg balance scale (BBS)
Time frame: Change from Baseline BBS at 8 weeks
Freezing of gait questionnaire
Time frame: Change from Baseline Freezing of gait questionnaire at 4 weeks
Freezing of gait questionnaire
Time frame: Change from Baseline Freezing of gait questionnaire at 8 weeks
Fear of falling
Time frame: Change from Baseline fear of falling at 4 weeks
Fear of falling
Time frame: Change from Baseline fear of falling at 8 weeks
Total number of falls during the recent 1 month
Time frame: Change from Baseline total number of falls at 4 weeks
Total number of falls during the recent 1 month
Time frame: Change from Baseline total number of falls at 8 weeks
User satisfaction evaluation questionnaire
Time frame: At 4weeks (after the completion of whole interventions)
Gait parameters from gait analysis
Time frame: Change from Baseline gait parameters at 4 weeks
Gait parameters from gait analysis
Time frame: Change from Baseline gait parameters at 8 weeks
Unified Parkinson's disease rating scale (UPDRS) part III
Time frame: Change from Baseline UPDRS III at 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
Individual participant dataSharing planned: Undecided

Related trials for Virtual Reality; Rehabilitation; Parkinson's Disease

Not yet recruiting
Cognitive-Based Balance Rehabilitation in Parkinson's Disease: Virtual Reality vs. Dual Task
PARKINSON DISEASE (Disorder), Parkinson Disease (PD)
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Collaborative vs Non-Immersive VR in Parkinson's Rehabilitation
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Not yet recruiting
Comparative Effects of Virtual Reality and Proprioceptive Neuromuscular Facilitation in Patients With Parkinson's Disease
Parkinson Disease
Active, not recruiting
Design And Analysis of The Effectiveness of CVRE VS Non-Immersive VR in the Rehabilitation of Parkinson
Parkinson Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Unified Parkinson's disease rating scale (UPDRS) part III (time frame: Change from Baseline UPDRS III at 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03686462.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.