StrokeNCT05709587
Impacts of Application of Virtual Reality on Gait and Balance for Stroke Patients
A study testing Virtual reality training in people with Stroke, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to learn about effects of virtual reality combined with conventional therapy on the balance, gait, and quality of life in stroke patients in the subacute and chronic stages. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Virtual reality training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jun 2020to 7 Oct 2020
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Clinical diagnosis of Stroke. 2. Must be able to ambulation with or without devices. 3. Were able to communicate and follow instructions. 4. Were rehabilitated at Kaohsiung Municipal Ta-Tung Hospital.
Who cannot join
- 1. Limb apraxia. 2. Any vision impairments. 3. Any hearing impairments. 4. Any vestibular impairments. 5. Any comorbidities that affected movements.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Kaohsiung Municipal Ta-Tung Hospital (operation under entrustment with Kaohsiung Medical University Hospital)
Kaohsiung City, 801
About this study
Official title: Effects of Virtual Reality Training on the Balance, Gait, and Quality of Life Improvements of Patients With Stroke in the Subacute and Chronic Stages.
The goal of this clinical trial is to learn about effects of virtual reality combined with conventional therapy on the balance, gait, and quality of life in stroke patients in the subacute and chronic stages. The main questions it aims to answer are:
- Virtual reality combined conventional therapy interventions can improve the gait, balance and functional status of stroke patients or not?
Participants will asked to do about 3 tasks in virtual reality intervention
- Walk in the flat ground
- Cross the obstacle on the ground
- Cross to moving obstacles
Read the detailed description
The investigators referred to the scenes designed by previous studies to develop the three virtual environments employed in this study and made slight modifications according to Taiwan's conditions. Google Earth Virtual Reality (Google Inc., Mountain View, California, U.S., 2017) was uesd for the first and second task and Street Champ Virtual Reality (Zynk Software Srl , Cluj, Romania, 2016) was used for the third task.
Time constraints, terrain changes, and moving obstacles were set to increase the difficulty of the walking task. The speed obtained by the 10-m walking pretest was used as the training benchmark. The participants had to complete a task three times to proceed to the next level.
For Patient Registries: on-site audit.The subjects were referred from the rehabilitation Clinic of Kaohsiung Municipal Ta-Tung Hospital
- Conditions
- Stroke
- Being tested
- Virtual reality training
- Keywords
- stroke, balance, virtual reality, walking pace, gait
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality trainingOther
Virtual reality Training for 12 sessions, two to three times for one week, one training session last for 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality training group | Experimental | Virtual Reality training group: Three virtual environments employed in this study,time constraints,terrain changes, and moving obstacles were set to increase the difficulty of the walking task.The participants had to complete a task three times to proceed to the next level. Receives: Other: Virtual reality training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking pace
Use the 10 meters walking test to show the outcomes that presents in m/s.
Measured: Measure changes from baseline walking pace tested before the intervention to one week after completion of all interventions.
Walking endurance
Use the 6 minutes walking test to show the outcomes that calculate the distance in meters.
Measured: Measure changes from baseline walking distance tested before the intervention to one week after completion of all interventions.
Balance test
Use the Berg Balance Scale to show the balance outcomes. It consists of 14 items scored 0 to 4 for a total of 56 points. A higher score means lower fall risk.
Measured: Measure changes from baseline Berg Balance Scale score tested before the intervention to one week after completion of all interventions.
Activities-specific balance confidence scale
Use the Chinese version of the activities-specific balance confidence scale to show the outcomes.It consists of 15 items every item score on 0 to 100. 0 means no confidence to perform the tasks, 100 means fully confidence to finish tasks.
Measured: Measure changes from baseline score of Chinese version of the activities-specific balance confidence scale tested before the intervention to one week after completion of all interventions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start1 Jun 2020
- Primary completion7 Oct 2020
- Study completion7 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial 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
- Not applicable
- Intervention model
- Single group
- Model description
- The subjects that received virtual reality functional gait training for 12 sessions. During the virtual reality intervention, they also received routine conventional rehabilitation therapy for twice a week, and training lasted for one hour. The 6-minute walking test (6MWT), 10-meter walk test (10MWT), Berg balance scale (BBS) and Chinese version of the Activities specific Balance Confidence scale were assessed pre- and post-intervention.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi-Chueh Tsai, BS, Principal investigator, Kaohsiung Municipal Ta-Tung Hospital (Operation under entrustment with KMUH )
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709587
- Sponsor's protocol ID
- KMUHIRB-F(I)-20190135
- Status last verified
- Jan 2020
- First submitted
- 11 Jan 2023
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fung J, Richards CL, Malouin F, McFadyen BJ, Lamontagne A. A treadmill and motion coupled virtual reality system for gait training post-stroke. Cyberpsychol Behav. 2006 Apr;9(2):157-62. doi: 10.1089/cpb.2006.9.157.
PubMed 16640470Richards CL, Malouin F, Lamontagne A, McFadyen BJ, Dumas F, Comeau F, Robitaille NM, Fung J. Gait Training after Stroke on a Self-Paced Treadmill with and without Virtual Environment Scenarios: A Proof-of-Principle Study. Physiother Can. 2018 Summer;70(3):221-230. doi: 10.3138/ptc.2016-97.
PubMed 30275647
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality Training on the Balance, Gait, and Quality of Life Improvements of Patients With Stroke in the Subacute and Chronic Stages.
- ClinicalTrials.gov ID
- NCT05709587
- Acronym / sponsor ID
- KMUHIRB-F(I)-20190135
- Conditions
- Stroke
- Keywords
- stroke, balance, virtual reality, walking pace, gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 7 Oct 2020 (actual)
- First posted
- 2 Feb 2023 (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.
The goal of this clinical trial is to learn about effects of virtual reality combined with conventional therapy on the balance, gait, and quality of life in stroke patients in the subacute and chronic stages. The main questions it aims to answer are:
- Virtual reality combined conventional therapy interventions can improve the gait, balance and functional status of stroke patients or not?
Participants will asked to do about 3 tasks in virtual reality intervention
- Walk in the flat ground
- Cross the obstacle on the ground
- Cross to moving obstacles
Detailed description
The investigators referred to the scenes designed by previous studies to develop the three virtual environments employed in this study and made slight modifications according to Taiwan's conditions. Google Earth Virtual Reality (Google Inc., Mountain View, California, U.S., 2017) was uesd for the first and second task and Street Champ Virtual Reality (Zynk Software Srl , Cluj, Romania, 2016) was used for the third task.
Time constraints, terrain changes, and moving obstacles were set to increase the difficulty of the walking task. The speed obtained by the 10-m walking pretest was used as the training benchmark. The participants had to complete a task three times to proceed to the next level.
For Patient Registries: on-site audit.The subjects were referred from the rehabilitation Clinic of Kaohsiung Municipal Ta-Tung Hospital
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The subjects that received virtual reality functional gait training for 12 sessions. During the virtual reality intervention, they also received routine conventional rehabilitation therapy for twice a week, and training lasted for one hour. The 6-minute walking test (6MWT), 10-meter walk test (10MWT), Berg balance scale (BBS) and Chinese version of the Activities specific Balance Confidence scale were assessed pre- and post-intervention.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality training group | Experimental | Other: Virtual reality trainingVirtual Reality training group: Three virtual environments employed in this study,time constraints,terrain changes, and moving obstacles were set to increase the difficulty of the walking task.The participants had to complete a task three times to proceed to the next level. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Clinical diagnosis of Stroke. 2. Must be able to ambulation with or without devices. 3. Were able to communicate and follow instructions. 4. Were rehabilitated at Kaohsiung Municipal Ta-Tung Hospital.
Key exclusion criteria (1 listed)
- 1. Limb apraxia. 2. Any vision impairments. 3. Any hearing impairments. 4. Any vestibular impairments. 5. Any comorbidities that affected movements.
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 trainingVirtual reality Training for 12 sessions, two to three times for one week, one training session last for 20 minutes | Other | Virtual Reality training group |
Primary outcome
Walking pace
Time frame: Measure changes from baseline walking pace tested before the intervention to one week after completion of all interventions.
Use the 10 meters walking test to show the outcomes that presents in m/s.
Walking endurance
Time frame: Measure changes from baseline walking distance tested before the intervention to one week after completion of all interventions.
Use the 6 minutes walking test to show the outcomes that calculate the distance in meters.
Balance test
Time frame: Measure changes from baseline Berg Balance Scale score tested before the intervention to one week after completion of all interventions.
Use the Berg Balance Scale to show the balance outcomes. It consists of 14 items scored 0 to 4 for a total of 56 points. A higher score means lower fall risk.
Activities-specific balance confidence scale
Time frame: Measure changes from baseline score of Chinese version of the activities-specific balance confidence scale tested before the intervention to one week after completion of all interventions.
Use the Chinese version of the activities-specific balance confidence scale to show the outcomes.It consists of 15 items every item score on 0 to 100. 0 means no confidence to perform the tasks, 100 means fully confidence to finish tasks.
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 2 Feb 2023.
- Background: PubMed 16640470Fung J, Richards CL, Malouin F, McFadyen BJ, Lamontagne A. A treadmill and motion coupled virtual reality system for gait training post-stroke. Cyberpsychol Behav. 2006 Apr;9(2):157-62. doi: 10.1089/cpb.2006.9.157.
- Background: PubMed 30275647Richards CL, Malouin F, Lamontagne A, McFadyen BJ, Dumas F, Comeau F, Robitaille NM, Fung J. Gait Training after Stroke on a Self-Paced Treadmill with and without Virtual Environment Scenarios: A Proof-of-Principle Study. Physiother Can. 2018 Summer;70(3):221-230. doi: 10.3138/ptc.2016-97.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Yi-Chueh Tsai, BS principal investigator
Kaohsiung Municipal Ta-Tung Hospital (Operation under entrustment with KMUH )
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality training in people with Stroke, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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 2 Feb 2023. 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 Taiwan. 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. 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?
Walking pace (time frame: Measure changes from baseline walking pace tested before the intervention to one week after completion of all interventions.). The study lists 4 primary outcomes in all. 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 NCT05709587, which also lists 2 linked publications.
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 2 Feb 2023.