StrokeNCT02735265
Rehabilitation Effects on Balance With Kinect for Xbox Virtual Reality Games
A study testing Virtual reality and Standard treatment in people with Stroke, run by Taipei Medical University Shuang Ho Hospital.
Trial summary
Virtual reality balance training has already been used in stroke rehabilitation, and previous studies supported that could improve balance ability. Although the treatment effects were supported in studies, there are still limitations in clinical intervention and the study power is not enough. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Virtual reality and Standard treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Feb 2016
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic stroke person (onset>6m)
- Could understand game command
- Could stand unsupported or stand with advice at least 15 minute
- Brunnstrom stage of LE ≥Ⅲ
Who cannot join
- Age >75 years old or <20 years old
- Severe visual or auditory impairment
- Modified Ashworth Scale of LE ≥ 3
- The Montreal Cognitive Assessment<16
- Other medication(neural, cardio-pulmonary, musculoskeletal) that influence motor command during the game
About this study
Official title: Evaluation of the Rehabilitation Effects on Balance With Kinect for Xbox Virtual Reality Games for Patients With Stroke
Virtual reality balance training has already been used in stroke rehabilitation, and previous studies supported that could improve balance ability. Although the treatment effects were supported in studies, there are still limitations in clinical intervention and the study power is not enough.
Study will use Kinect for Xbox games for balance intervention. Investigators will recruit 60 patients with chronic stroke from Shung-ho hospital clinical rehabilitation and randomly assign participants to "standard treatment plus virtual reality group" (N=30) and "standard treatment only group" (N=30). There are total 12 sessions (2 times weekly) for both groups. Investigators will assess subjects' ability for 3 times (pre- and post-intervention, follow up in post 3 month).Investigators will also record the pleasure scale and adverse event after every training session. Hypothesis is that Kinect for Xbox intervention can significantly improve subjects' balance ability, confidence of balance, ADL, and QOL compared to the conventional rehabilitation. It may help to develop a new clinical model of virtual reality training for patients with chronic stroke.
Read the detailed description
Many stroke survivors suffered postural and balance problems. Decreased mobility limits their daily life activities. Virtual reality balance training has already been used in stroke rehabilitation, and previous studies supported that could improve balance ability. The mechanism is multi-sensory feedback and repeated practices that could facilitate motor learning and brain neuroplasticity. Compared to conventional rehabilitation, VR rehabilitation could increase subjects' motivation and pleasure. Although the treatment effects were supported in studies, there are still limitations in clinical intervention and the study power is not enough.
The study will use Kinect for Xbox games for balance intervention. Kinect for Xbox doesn't need additional controller held by subjects and can detect the movement in real time to give subjects visual and auditory feedback immediately. Investigators will recruit 60 patients with chronic stroke from Shung-ho hospital clinical rehabilitation and randomly assign them to "standard treatment plus virtual reality group" (N=30) and "standard treatment only group" (N=30). There are total 12 sessions (2 times weekly) for both groups. Investigators will assess subjects' ability for 3 times (pre- and post-intervention, follow up in post 3 month). The outcome measures include Force plate, Functional reach test, Berg Balance Scale, Time up and go for balance evaluations, Modified barthel index for ADL ability, Activities-specific Balance Confidence scale for balance confidence, and Stroke Impact Scale for quality of life. Investigators will also record the pleasure scale and adverse event after every training session. Collected data will be analyzed with repeated measures 2-way analysis of variance (ANOVA), Turkey test post hoc and independent T sample test. Hypothesis is that Kinect for Xbox intervention can significantly improve subjects' balance ability, confidence of balance, ADL, and QOL compared to the conventional rehabilitation. It may help to develop a new clinical model of virtual reality training for patients with chronic stroke.
- Conditions
- Stroke
- Being tested
- Virtual reality, Standard treatment
- Keywords
- Rehabilitation, Virtual reality
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityBehavioural
12 training sessions (90 minutes a time, 2 times a week) IG:45 minute of Kinect for Xbox games and 45 minute of standard treatment.
Standard treatmentBehavioural
CG: 90 minute of standard treatment. 12 training sessions (90 minutes a time, 2 times a week)
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality group | Experimental | 45 min standard treatment plus 45 min virtual reality balance training used by Kinect for Xbox game. Game choosed based on motor learning principle. Training task such as reach or stepping in various direction, squat, stand up, upper trunk forward or lateral bench. Receives: Behavioral: Virtual reality; Behavioral: Standard treatment |
| Standard treatment only group | Active comparator | 90 min standard treatment. Depended on patient's ability, principle used by motor learning, sensory process, motor control, task oriented training, symmetry w't bearing. Receives: Behavioral: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
balance function
Measured: Change from Baseline at 6 weeks and 3 month follow up
Secondary outcomes (8)
Modified barthel index
Activity of daily live ability
Measured: Change from Baseline at 6 weeks and 3 month follow up
Activities-specific Balance Confidence scale
balance confidence
Measured: Change from Baseline at 6 weeks and 3 month follow up
Stroke Impact Scale
quality of life
Measured: Change from Baseline at 6 weeks and 3 month follow up
Modified Physical Activity Enjoyment Scale
pleasure scale
Measured: Every training session during 6 weeks (total 12 sessions (2 times weekly))
Adverse event times
Measured: Every training session during 6 weeks (total 12 sessions (2 times weekly))
Force plate
balance function for Weight bearing symmetry and dynamic standing balance
Measured: Change from Baseline at 6 weeks and 3 month follow up
Functional reach test
balance function
Measured: Change from Baseline at 6 weeks and 3 month follow up
Timed up and go-cognition
balance function
Measured: Change from Baseline at 6 weeks and 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startFeb 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsinchieh Lee, master, Study chair, Taipei Medical University, Taiwan, R.O.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02735265
- Sponsor's protocol ID
- TMU-JIRB 201412023
- Status last verified
- Mar 2016
- First submitted
- 21 Mar 2016
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Celinder D, Peoples H. Stroke patients' experiences with Wii Sports(R) during inpatient rehabilitation. Scand J Occup Ther. 2012 Sep;19(5):457-63. doi: 10.3109/11038128.2012.655307. Epub 2012 Feb 20.
PubMed 22339207Cho K, Lee G. Impaired dynamic balance is associated with falling in post-stroke patients. Tohoku J Exp Med. 2013 Aug;230(4):233-9. doi: 10.1620/tjem.230.233.
PubMed 23933665Cho KH, Lee KJ, Song CH. Virtual-reality balance training with a video-game system improves dynamic balance in chronic stroke patients. Tohoku J Exp Med. 2012 Sep;228(1):69-74. doi: 10.1620/tjem.228.69.
PubMed 22976384Cuthbert JP, Staniszewski K, Hays K, Gerber D, Natale A, O'Dell D. Virtual reality-based therapy for the treatment of balance deficits in patients receiving inpatient rehabilitation for traumatic brain injury. Brain Inj. 2014;28(2):181-8. doi: 10.3109/02699052.2013.860475.
PubMed 24456057Deutsch J, R. D., Morrison J, Guarrera Bowlby P ( 2009). Wii-Based Compared to Standard of Care Balance and Mobility Rehabilitation for Two Individuals Post-Stroke. 117-120.
Deutsch JE. Using virtual reality to improve walking post-stroke: translation to individuals with diabetes. J Diabetes Sci Technol. 2011 Mar 1;5(2):309-14. doi: 10.1177/193229681100500216.
PubMed 21527098Deutsch JE, Borbely M, Filler J, Huhn K, Guarrera-Bowlby P. Use of a low-cost, commercially available gaming console (Wii) for rehabilitation of an adolescent with cerebral palsy. Phys Ther. 2008 Oct;88(10):1196-207. doi: 10.2522/ptj.20080062. Epub 2008 Aug 8.
PubMed 18689607Deutsch JE, Brettler A, Smith C, Welsh J, John R, Guarrera-Bowlby P, Kafri M. Nintendo wii sports and wii fit game analysis, validation, and application to stroke rehabilitation. Top Stroke Rehabil. 2011 Nov-Dec;18(6):701-19. doi: 10.1310/tsr1806-701.
PubMed 22436308Deutsch JE, R. D., Morrison J, Guarrera Bowlby P (2009). Wii-Based Compared to Standard of Care Balance and Mobility Rehabilitation for Two Individuals Post-Stroke. In Virtual Rehabilitation International Conference; Haifa., 117-120.
Gil-Gomez JA, Llorens R, Alcaniz M, Colomer C. Effectiveness of a Wii balance board-based system (eBaViR) for balance rehabilitation: a pilot randomized clinical trial in patients with acquired brain injury. J Neuroeng Rehabil. 2011 May 23;8:30. doi: 10.1186/1743-0003-8-30.
PubMed 21600066Kim JH, Jang SH, Kim CS, Jung JH, You JH. Use of virtual reality to enhance balance and ambulation in chronic stroke: a double-blind, randomized controlled study. Am J Phys Med Rehabil. 2009 Sep;88(9):693-701. doi: 10.1097/PHM.0b013e3181b33350.
PubMed 19692788Kizony R, Levin MF, Hughey L, Perez C, Fung J. Cognitive load and dual-task performance during locomotion poststroke: a feasibility study using a functional virtual environment. Phys Ther. 2010 Feb;90(2):252-60. doi: 10.2522/ptj.20090061. Epub 2009 Dec 18.
PubMed 20023003Kizony R, Raz L, Katz N, Weingarden H, Weiss PL. Video-capture virtual reality system for patients with paraplegic spinal cord injury. J Rehabil Res Dev. 2005 Sep-Oct;42(5):595-608. doi: 10.1682/jrrd.2005.01.0023.
PubMed 16586185Koepp MJ, Gunn RN, Lawrence AD, Cunningham VJ, Dagher A, Jones T, Brooks DJ, Bench CJ, Grasby PM. Evidence for striatal dopamine release during a video game. Nature. 1998 May 21;393(6682):266-8. doi: 10.1038/30498.
PubMed 9607763Lange B, Flynn S, Proffitt R, Chang CY, Rizzo AS. Development of an interactive game-based rehabilitation tool for dynamic balance training. Top Stroke Rehabil. 2010 Sep-Oct;17(5):345-52. doi: 10.1310/tsr1705-345.
PubMed 21131259
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Rehabilitation Effects on Balance With Kinect for Xbox Virtual Reality Games for Patients With Stroke
- ClinicalTrials.gov ID
- NCT02735265
- Acronym / sponsor ID
- TMU-JIRB 201412023
- Conditions
- Stroke
- Keywords
- Rehabilitation, Virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 12 Apr 2016 (estimated)
- 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.
Virtual reality balance training has already been used in stroke rehabilitation, and previous studies supported that could improve balance ability. Although the treatment effects were supported in studies, there are still limitations in clinical intervention and the study power is not enough.
Study will use Kinect for Xbox games for balance intervention. Investigators will recruit 60 patients with chronic stroke from Shung-ho hospital clinical rehabilitation and randomly assign participants to "standard treatment plus virtual reality group" (N=30) and "standard treatment only group" (N=30). There are total 12 sessions (2 times weekly) for both groups. Investigators will assess subjects' ability for 3 times (pre- and post-intervention, follow up in post 3 month).Investigators will also record the pleasure scale and adverse event after every training session. Hypothesis is that Kinect for Xbox intervention can significantly improve subjects' balance ability, confidence of balance, ADL, and QOL compared to the conventional rehabilitation. It may help to develop a new clinical model of virtual reality training for patients with chronic stroke.
Detailed description
Many stroke survivors suffered postural and balance problems. Decreased mobility limits their daily life activities. Virtual reality balance training has already been used in stroke rehabilitation, and previous studies supported that could improve balance ability. The mechanism is multi-sensory feedback and repeated practices that could facilitate motor learning and brain neuroplasticity. Compared to conventional rehabilitation, VR rehabilitation could increase subjects' motivation and pleasure. Although the treatment effects were supported in studies, there are still limitations in clinical intervention and the study power is not enough.
The study will use Kinect for Xbox games for balance intervention. Kinect for Xbox doesn't need additional controller held by subjects and can detect the movement in real time to give subjects visual and auditory feedback immediately. Investigators will recruit 60 patients with chronic stroke from Shung-ho hospital clinical rehabilitation and randomly assign them to "standard treatment plus virtual reality group" (N=30) and "standard treatment only group" (N=30). There are total 12 sessions (2 times weekly) for both groups. Investigators will assess subjects' ability for 3 times (pre- and post-intervention, follow up in post 3 month). The outcome measures include Force plate, Functional reach test, Berg Balance Scale, Time up and go for balance evaluations, Modified barthel index for ADL ability, Activities-specific Balance Confidence scale for balance confidence, and Stroke Impact Scale for quality of life. Investigators will also record the pleasure scale and adverse event after every training session. Collected data will be analyzed with repeated measures 2-way analysis of variance (ANOVA), Turkey test post hoc and independent T sample test. Hypothesis is that Kinect for Xbox intervention can significantly improve subjects' balance ability, confidence of balance, ADL, and QOL compared to the conventional rehabilitation. It may help to develop a new clinical model of virtual reality training for patients with chronic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality group | Experimental | Behavioral: Virtual reality, Behavioral: Standard treatment45 min standard treatment plus 45 min virtual reality balance training used by Kinect for Xbox game. Game choosed based on motor learning principle. Training task such as reach or stepping in various direction, squat, stand up, upper trunk forward or lateral bench. |
| Standard treatment only group | Active comparator | Behavioral: Standard treatment90 min standard treatment. Depended on patient's ability, principle used by motor learning, sensory process, motor control, task oriented training, symmetry w't bearing. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic stroke person (onset>6m)
- Could understand game command
- Could stand unsupported or stand with advice at least 15 minute
- Brunnstrom stage of LE ≥Ⅲ
Key exclusion criteria (5 listed)
- Age >75 years old or <20 years old
- Severe visual or auditory impairment
- Modified Ashworth Scale of LE ≥ 3
- The Montreal Cognitive Assessment<16
- Other medication(neural, cardio-pulmonary, musculoskeletal) that influence motor command during the game
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 reality12 training sessions (90 minutes a time, 2 times a week) IG:45 minute of Kinect for Xbox games and 45 minute of standard treatment. | Behavioural | Virtual reality group |
| Standard treatmentCG: 90 minute of standard treatment. 12 training sessions (90 minutes a time, 2 times a week) | Behavioural | Standard treatment only group, Virtual reality group |
Primary outcome
Berg Balance Scale
Time frame: Change from Baseline at 6 weeks and 3 month follow up
balance function
8 secondary outcomes
Modified barthel index
Time frame: Change from Baseline at 6 weeks and 3 month follow up
Activities-specific Balance Confidence scale
Time frame: Change from Baseline at 6 weeks and 3 month follow up
Stroke Impact Scale
Time frame: Change from Baseline at 6 weeks and 3 month follow up
Modified Physical Activity Enjoyment Scale
Time frame: Every training session during 6 weeks (total 12 sessions (2 times weekly))
Adverse event times
Time frame: Every training session during 6 weeks (total 12 sessions (2 times weekly))
Force plate
Time frame: Change from Baseline at 6 weeks and 3 month follow up
Functional reach test
Time frame: Change from Baseline at 6 weeks and 3 month follow up
Timed up and go-cognition
Time frame: Change from Baseline at 6 weeks and 3 month follow up
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 12 Apr 2016.
- Background: PubMed 22339207Celinder D, Peoples H. Stroke patients' experiences with Wii Sports(R) during inpatient rehabilitation. Scand J Occup Ther. 2012 Sep;19(5):457-63. doi: 10.3109/11038128.2012.655307. Epub 2012 Feb 20.
- Background: PubMed 23933665Cho K, Lee G. Impaired dynamic balance is associated with falling in post-stroke patients. Tohoku J Exp Med. 2013 Aug;230(4):233-9. doi: 10.1620/tjem.230.233.
- Background: PubMed 22976384Cho KH, Lee KJ, Song CH. Virtual-reality balance training with a video-game system improves dynamic balance in chronic stroke patients. Tohoku J Exp Med. 2012 Sep;228(1):69-74. doi: 10.1620/tjem.228.69.
- Background: PubMed 24456057Cuthbert JP, Staniszewski K, Hays K, Gerber D, Natale A, O'Dell D. Virtual reality-based therapy for the treatment of balance deficits in patients receiving inpatient rehabilitation for traumatic brain injury. Brain Inj. 2014;28(2):181-8. doi: 10.3109/02699052.2013.860475.
- BackgroundDeutsch J, R. D., Morrison J, Guarrera Bowlby P ( 2009). Wii-Based Compared to Standard of Care Balance and Mobility Rehabilitation for Two Individuals Post-Stroke. 117-120.
- Background: PubMed 21527098Deutsch JE. Using virtual reality to improve walking post-stroke: translation to individuals with diabetes. J Diabetes Sci Technol. 2011 Mar 1;5(2):309-14. doi: 10.1177/193229681100500216.
- Background: PubMed 18689607Deutsch JE, Borbely M, Filler J, Huhn K, Guarrera-Bowlby P. Use of a low-cost, commercially available gaming console (Wii) for rehabilitation of an adolescent with cerebral palsy. Phys Ther. 2008 Oct;88(10):1196-207. doi: 10.2522/ptj.20080062. Epub 2008 Aug 8.
- Background: PubMed 22436308Deutsch JE, Brettler A, Smith C, Welsh J, John R, Guarrera-Bowlby P, Kafri M. Nintendo wii sports and wii fit game analysis, validation, and application to stroke rehabilitation. Top Stroke Rehabil. 2011 Nov-Dec;18(6):701-19. doi: 10.1310/tsr1806-701.
- BackgroundDeutsch JE, R. D., Morrison J, Guarrera Bowlby P (2009). Wii-Based Compared to Standard of Care Balance and Mobility Rehabilitation for Two Individuals Post-Stroke. In Virtual Rehabilitation International Conference; Haifa., 117-120.
- Background: PubMed 21600066Gil-Gomez JA, Llorens R, Alcaniz M, Colomer C. Effectiveness of a Wii balance board-based system (eBaViR) for balance rehabilitation: a pilot randomized clinical trial in patients with acquired brain injury. J Neuroeng Rehabil. 2011 May 23;8:30. doi: 10.1186/1743-0003-8-30.
- Background: PubMed 19692788Kim JH, Jang SH, Kim CS, Jung JH, You JH. Use of virtual reality to enhance balance and ambulation in chronic stroke: a double-blind, randomized controlled study. Am J Phys Med Rehabil. 2009 Sep;88(9):693-701. doi: 10.1097/PHM.0b013e3181b33350.
- Background: PubMed 20023003Kizony R, Levin MF, Hughey L, Perez C, Fung J. Cognitive load and dual-task performance during locomotion poststroke: a feasibility study using a functional virtual environment. Phys Ther. 2010 Feb;90(2):252-60. doi: 10.2522/ptj.20090061. Epub 2009 Dec 18.
- Individual participant dataSharing planned: Yes
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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.
Hsinchieh Lee, master study chair
Taipei Medical University, Taiwan, R.O.C.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality and Standard treatment in people with Stroke, run by Taipei Medical University Shuang Ho Hospital.
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 4 inclusion and 5 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 12 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Berg Balance Scale (time frame: Change from Baseline at 6 weeks and 3 month follow up). 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 NCT02735265, which also lists 36 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 12 Apr 2016.