Rehabilitation Effects on Balance With Kinect for Xbox Virtual Reality Games
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual reality
Standard treatment
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring Rehabilitation, Virtual reality
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Virtual reality group
Standard treatment only group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Berg Balance Scale
balance function
Secondary Outcome Measures
Modified barthel index
Activity of daily live ability
Activities-specific Balance Confidence scale
balance confidence
Stroke Impact Scale
quality of life
Modified Physical Activity Enjoyment Scale
pleasure scale
Adverse event times
Force plate
balance function for Weight bearing symmetry and dynamic standing balance
Functional reach test
balance function
Timed up and go-cognition
balance function
Full Information
NCT ID
NCT02735265
First Posted
March 21, 2016
Last Updated
April 11, 2016
Sponsor
Taipei Medical University Shuang Ho Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02735265
Brief Title
Rehabilitation Effects on Balance With Kinect for Xbox Virtual Reality Games
Official Title
Evaluation of the Rehabilitation Effects on Balance With Kinect for Xbox Virtual Reality Games for Patients With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University Shuang Ho Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Rehabilitation, Virtual reality
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality group
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard treatment only group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual reality
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard treatment
Intervention Description
CG: 90 minute of standard treatment. 12 training sessions (90 minutes a time, 2 times a week)
Primary Outcome Measure Information:
Title
Berg Balance Scale
Description
balance function
Time Frame
Change from Baseline at 6 weeks and 3 month follow up
Secondary Outcome Measure Information:
Title
Modified barthel index
Description
Activity of daily live ability
Time Frame
Change from Baseline at 6 weeks and 3 month follow up
Title
Activities-specific Balance Confidence scale
Description
balance confidence
Time Frame
Change from Baseline at 6 weeks and 3 month follow up
Title
Stroke Impact Scale
Description
quality of life
Time Frame
Change from Baseline at 6 weeks and 3 month follow up
Title
Modified Physical Activity Enjoyment Scale
Description
pleasure scale
Time Frame
Every training session during 6 weeks (total 12 sessions (2 times weekly))
Title
Adverse event times
Time Frame
Every training session during 6 weeks (total 12 sessions (2 times weekly))
Title
Force plate
Description
balance function for Weight bearing symmetry and dynamic standing balance
Time Frame
Change from Baseline at 6 weeks and 3 month follow up
Title
Functional reach test
Description
balance function
Time Frame
Change from Baseline at 6 weeks and 3 month follow up
Title
Timed up and go-cognition
Description
balance function
Time Frame
Change from Baseline at 6 weeks and 3 month follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsinchieh Lee, master
Organizational Affiliation
Taipei Medical University, Taiwan, R.O.C.
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
22339207
Citation
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.
Results Reference
background
PubMed Identifier
23933665
Citation
Cho 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.
Results Reference
background
PubMed Identifier
22976384
Citation
Cho 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.
Results Reference
background
PubMed Identifier
24456057
Citation
Cuthbert 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.
Results Reference
background
Citation
Deutsch 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.
Results Reference
background
PubMed Identifier
21527098
Citation
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.
Results Reference
background
PubMed Identifier
18689607
Citation
Deutsch 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.
Results Reference
background
PubMed Identifier
22436308
Citation
Deutsch 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.
Results Reference
background
Citation
Deutsch 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.
Results Reference
background
PubMed Identifier
21600066
Citation
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.
Results Reference
background
PubMed Identifier
19692788
Citation
Kim 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.
Results Reference
background
PubMed Identifier
20023003
Citation
Kizony 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.
Results Reference
background
PubMed Identifier
16586185
Citation
Kizony 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.
Results Reference
background
PubMed Identifier
9607763
Citation
Koepp 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.
Results Reference
background
PubMed Identifier
21131259
Citation
Lange 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.
Results Reference
background
Citation
Lange, B., Flynn, S., & Rizzo, A. (2009). Initial usability assessment of off-the-shelf video game consoles for clinical game-based motor rehabilitation. Physical Therapy Reviews, 14(5), 355.
Results Reference
background
PubMed Identifier
19443914
Citation
Larsen CR, Soerensen JL, Grantcharov TP, Dalsgaard T, Schouenborg L, Ottosen C, Schroeder TV, Ottesen BS. Effect of virtual reality training on laparoscopic surgery: randomised controlled trial. BMJ. 2009 May 14;338:b1802. doi: 10.1136/bmj.b1802. Erratum In: BMJ. 2009;338. doi: 10.1136/bmj.b2074.
Results Reference
background
PubMed Identifier
22713539
Citation
Laver K, George S, Thomas S, Deutsch JE, Crotty M. Cochrane review: virtual reality for stroke rehabilitation. Eur J Phys Rehabil Med. 2012 Sep;48(3):523-30. Epub 2012 Jun 20.
Results Reference
background
PubMed Identifier
24259810
Citation
Lee G. Effects of training using video games on the muscle strength, muscle tone, and activities of daily living of chronic stroke patients. J Phys Ther Sci. 2013 May;25(5):595-7. doi: 10.1589/jpts.25.595. Epub 2013 Jun 29.
Results Reference
background
Citation
Lintern G, R. S., Koonce J, Segal L (1990). Display principles,control dynamics and environmental factors in pilot training and transfer. . Human Factors, 32, 299-317.
Results Reference
background
PubMed Identifier
24232363
Citation
Lohse K, Shirzad N, Verster A, Hodges N, Van der Loos HF. Video games and rehabilitation: using design principles to enhance engagement in physical therapy. J Neurol Phys Ther. 2013 Dec;37(4):166-75. doi: 10.1097/NPT.0000000000000017.
Results Reference
background
PubMed Identifier
16084807
Citation
Michael KM, Allen JK, Macko RF. Reduced ambulatory activity after stroke: the role of balance, gait, and cardiovascular fitness. Arch Phys Med Rehabil. 2005 Aug;86(8):1552-6. doi: 10.1016/j.apmr.2004.12.026.
Results Reference
background
PubMed Identifier
24296065
Citation
Parry I, Carbullido C, Kawada J, Bagley A, Sen S, Greenhalgh D, Palmieri T. Keeping up with video game technology: objective analysis of Xbox Kinect and PlayStation 3 Move for use in burn rehabilitation. Burns. 2014 Aug;40(5):852-9. doi: 10.1016/j.burns.2013.11.005. Epub 2013 Dec 2.
Results Reference
background
PubMed Identifier
23872681
Citation
Peters DM, McPherson AK, Fletcher B, McClenaghan BA, Fritz SL. Counting repetitions: an observational study of video game play in people with chronic poststroke hemiparesis. J Neurol Phys Ther. 2013 Sep;37(3):105-11. doi: 10.1097/NPT.0b013e31829ee9bc.
Results Reference
background
PubMed Identifier
21651800
Citation
Pichierri G, Wolf P, Murer K, de Bruin ED. Cognitive and cognitive-motor interventions affecting physical functioning: a systematic review. BMC Geriatr. 2011 Jun 8;11:29. doi: 10.1186/1471-2318-11-29.
Results Reference
background
Citation
Schultheis M, R. A. (2001). The application of virtual reality technology in rehabilitation. Rehabilitation Psychology, 46, 296-311.
Results Reference
background
PubMed Identifier
24597650
Citation
Shin JH, Ryu H, Jang SH. A task-specific interactive game-based virtual reality rehabilitation system for patients with stroke: a usability test and two clinical experiments. J Neuroeng Rehabil. 2014 Mar 6;11:32. doi: 10.1186/1743-0003-11-32.
Results Reference
background
PubMed Identifier
24051993
Citation
Sin H, Lee G. Additional virtual reality training using Xbox Kinect in stroke survivors with hemiplegia. Am J Phys Med Rehabil. 2013 Oct;92(10):871-80. doi: 10.1097/PHM.0b013e3182a38e40.
Results Reference
background
Citation
Singh, D. K. A., Nordin, N. A.M., Aziz,N. A., Zarim, S.N. A., Kooi, L. B., Ching, S. L. . (2014). Can virtual reality balance games enhance activities of daily living among stroke survivors? BMC Public Health, 14, 1.
Results Reference
background
Citation
Smith, C., Read, J., Bennie, C., Hale, L., & Milosavljevic, S. (2012). Can non-immersive virtual reality improve physical outcomes of rehabilitation? Physical Therapy Reviews, 17(1), 1-15.
Results Reference
background
PubMed Identifier
24702281
Citation
Ustinova KI, Perkins J, Leonard WA, Hausbeck CJ. Virtual reality game-based therapy for treatment of postural and co-ordination abnormalities secondary to TBI: a pilot study. Brain Inj. 2014;28(4):486-95. doi: 10.3109/02699052.2014.888593. Epub 2014 Apr 4.
Results Reference
background
PubMed Identifier
24239167
Citation
Vernadakis N, Derri V, Tsitskari E, Antoniou P. The effect of Xbox Kinect intervention on balance ability for previously injured young competitive male athletes: a preliminary study. Phys Ther Sport. 2014 Aug;15(3):148-55. doi: 10.1016/j.ptsp.2013.08.004. Epub 2013 Sep 4.
Results Reference
background
PubMed Identifier
25309631
Citation
Wuest S, van de Langenberg R, de Bruin ED. Design considerations for a theory-driven exergame-based rehabilitation program to improve walking of persons with stroke. Eur Rev Aging Phys Act. 2014;11(2):119-129. doi: 10.1007/s11556-013-0136-6. Epub 2013 Dec 7.
Results Reference
background
PubMed Identifier
20544153
Citation
Yong Joo L, Soon Yin T, Xu D, Thia E, Pei Fen C, Kuah CW, Kong KH. A feasibility study using interactive commercial off-the-shelf computer gaming in upper limb rehabilitation in patients after stroke. J Rehabil Med. 2010 May;42(5):437-41. doi: 10.2340/16501977-0528.
Results Reference
background
PubMed Identifier
15890990
Citation
You SH, Jang SH, Kim YH, Hallett M, Ahn SH, Kwon YH, Kim JH, Lee MY. Virtual reality-induced cortical reorganization and associated locomotor recovery in chronic stroke: an experimenter-blind randomized study. Stroke. 2005 Jun;36(6):1166-71. doi: 10.1161/01.STR.0000162715.43417.91. Epub 2005 May 12. Erratum In: Stroke. 2005 Jul;36(7):1625.
Results Reference
background
PubMed Identifier
12917848
Citation
Zhang L, Abreu BC, Seale GS, Masel B, Christiansen CH, Ottenbacher KJ. A virtual reality environment for evaluation of a daily living skill in brain injury rehabilitation: reliability and validity. Arch Phys Med Rehabil. 2003 Aug;84(8):1118-24. doi: 10.1016/s0003-9993(03)00203-x.
Results Reference
background
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Rehabilitation Effects on Balance With Kinect for Xbox Virtual Reality Games
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