Effects of Wearable Sensor Based Virtual Reality Game on Balance for Stroke
NCT ID: NCT04297774
Last Updated: 2021-09-29
Study Results
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Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2020-05-02
2021-07-25
Brief Summary
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Detailed Description
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PURPOSE: The purpose of this study is to investigate the effects of virtual reality training through Pablo system in patients with chronic stroke.
METHODS: A prospective, randomized, controlled, blinded assessor design was used. Patients with stroke were recruited and randomly assigned to a "virtual reality(VR) group" (n = 20) and "functional balance training (FBT) group" (n = 20). After 18 training sessions (60 minutes per session, 2 sessions per week), outcome measures which included the Berg Balance Scale, the Timed Up and Go Test (cognition), a gait analysis, the Activities-Specific Balance Confidence scale, Stroke Impact Scale (SIS), Level of pleasure, and frequency of adverse events. The data were analyzed using nonparametric tests, and significance was indicated at α \< 0.05.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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virtual reality group
18 sessions of standard treatment plus virtual reality treatment.
virtual reality treatment
18 virtual reality training through Pablo system (30 minutes a time, 2-3 times a week). Postural transition included sit-to-stand, sit down, reaching to different directions, stepping to different directions with weight transfer, and bending the trunk forward and side to side. The controller was attached to lower extremity or trunk to control the game, such as elevator, hot air balloon, shooting cans, etc.
standard treatment
18 standard rehabilitation sessions (60 minutes a time, 2-3 times a week). The rehabilitative protocol focus on strengthening, endurance training, ambulation, and ADL training that included: (1) Hip flexor and knee extensor strengthening with resistance progressing used by weight bag or Thera-band. (2) Cycle ergometer riding with increase speed and resistance. (3) Gait pattern and speed correcting through treadmill and parallel bar. (4) Hand functional training and strategy teaching for feeding, dressing, and toileting.
standard treatment group
18 sessions of standard treatment plus balance training.
standard treatment
18 standard rehabilitation sessions (60 minutes a time, 2-3 times a week). The rehabilitative protocol focus on strengthening, endurance training, ambulation, and ADL training that included: (1) Hip flexor and knee extensor strengthening with resistance progressing used by weight bag or Thera-band. (2) Cycle ergometer riding with increase speed and resistance. (3) Gait pattern and speed correcting through treadmill and parallel bar. (4) Hand functional training and strategy teaching for feeding, dressing, and toileting.
balance training
18 balance training sessions (30 minutes a time, 2-3 times a week) (1) Facilitated the balance reaction through weight shifting exercise with standing on even surface to uneven surface, such as tilting board.(2) Postural transition included sit-to-stand, sit down, reaching to different directions, stepping to different directions with weight transfer, and bending the trunk forward and side to side. (3) Changed the standing requirement, such as single legged stance or lunge stance. (4) Increased perception complications through cognition or upper extremity task to improve dual task attention.
Interventions
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virtual reality treatment
18 virtual reality training through Pablo system (30 minutes a time, 2-3 times a week). Postural transition included sit-to-stand, sit down, reaching to different directions, stepping to different directions with weight transfer, and bending the trunk forward and side to side. The controller was attached to lower extremity or trunk to control the game, such as elevator, hot air balloon, shooting cans, etc.
standard treatment
18 standard rehabilitation sessions (60 minutes a time, 2-3 times a week). The rehabilitative protocol focus on strengthening, endurance training, ambulation, and ADL training that included: (1) Hip flexor and knee extensor strengthening with resistance progressing used by weight bag or Thera-band. (2) Cycle ergometer riding with increase speed and resistance. (3) Gait pattern and speed correcting through treadmill and parallel bar. (4) Hand functional training and strategy teaching for feeding, dressing, and toileting.
balance training
18 balance training sessions (30 minutes a time, 2-3 times a week) (1) Facilitated the balance reaction through weight shifting exercise with standing on even surface to uneven surface, such as tilting board.(2) Postural transition included sit-to-stand, sit down, reaching to different directions, stepping to different directions with weight transfer, and bending the trunk forward and side to side. (3) Changed the standing requirement, such as single legged stance or lunge stance. (4) Increased perception complications through cognition or upper extremity task to improve dual task attention.
Eligibility Criteria
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Inclusion Criteria
* Could stand for 5 minutes without support.
* Chronicity of \>6 months.
* Could understand instructions.
* Brunnstrom stage of LE ≥Ⅲ.
Exclusion Criteria
* Patients with visual or auditory impairment who were unable to see or hear the feedback from the device clearly
* Montreal Cognitive Assessment \<16
* Modified Ashworth Scale score of \>2
* Patients with other medical symptoms that can affect movement.
20 Years
75 Years
ALL
No
Sponsors
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Taipei Medical University Shuang Ho Hospital
OTHER
Responsible Party
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Principal Investigators
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Hsinchieh Lee, master
Role: PRINCIPAL_INVESTIGATOR
Taipei Medical University, Taiwan, R.O.C.
Locations
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Taipei Medical University Shuang Ho Hospital
Taipei, , Taiwan
Countries
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References
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Volpe BT, Lynch D, Rykman-Berland A, Ferraro M, Galgano M, Hogan N, Krebs HI. Intensive sensorimotor arm training mediated by therapist or robot improves hemiparesis in patients with chronic stroke. Neurorehabil Neural Repair. 2008 May-Jun;22(3):305-10. doi: 10.1177/1545968307311102. Epub 2008 Jan 9.
Hatano S. Experience from a multicentre stroke register: a preliminary report. Bull World Health Organ. 1976;54(5):541-53.
Gobbens RJ, van Assen MA. The Prediction of ADL and IADL Disability Using Six Physical Indicators of Frailty: A Longitudinal Study in the Netherlands. Curr Gerontol Geriatr Res. 2014;2014:358137. doi: 10.1155/2014/358137. Epub 2014 Mar 24.
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Deutsch, J.E., Robbins, D., Morrison, J., Guarrera, B.P. , Wii-Based Compared to Standard of Care Balance and Mobility Rehabilitation for Two Individuals Post-Stroke. In Virtual Rehabilitation International Conference; Haifa., 2009: p. 117-120.
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Buracchio TJ, Mattek NC, Dodge HH, Hayes TL, Pavel M, Howieson DB, Kaye JA. Executive function predicts risk of falls in older adults without balance impairment. BMC Geriatr. 2011 Nov 9;11:74. doi: 10.1186/1471-2318-11-74.
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Ordahan B, Karahan AY, Basaran A, Turkoglu G, Kucuksarac S, Cubukcu M, Tekin L, Polat AD, Kuran B. Impact of exercises administered to stroke patients with balance trainer on rehabilitation results: a randomized controlled study. Hippokratia. 2015 Apr-Jun;19(2):125-30.
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.
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.
Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2015 Feb 12;2015(2):CD008349. doi: 10.1002/14651858.CD008349.pub3.
Smith, C., et al., Can non-immersive virtual reality improve physical outcomes of rehabilitation? Physical Therapy Reviews, 2012. 17(1): p. 1-15.
Lohse KR, Hilderman CG, Cheung KL, Tatla S, Van der Loos HF. Virtual reality therapy for adults post-stroke: a systematic review and meta-analysis exploring virtual environments and commercial games in therapy. PLoS One. 2014 Mar 28;9(3):e93318. doi: 10.1371/journal.pone.0093318. eCollection 2014.
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.
Powell LE, Myers AM. The Activities-specific Balance Confidence (ABC) Scale. J Gerontol A Biol Sci Med Sci. 1995 Jan;50A(1):M28-34. doi: 10.1093/gerona/50a.1.m28.
Schmid AA, Van Puymbroeck M, Altenburger PA, Dierks TA, Miller KK, Damush TM, Williams LS. Balance and balance self-efficacy are associated with activity and participation after stroke: a cross-sectional study in people with chronic stroke. Arch Phys Med Rehabil. 2012 Jun;93(6):1101-7. doi: 10.1016/j.apmr.2012.01.020. Epub 2012 Apr 11.
Other Identifiers
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TMU-JIRB N201912048
Identifier Type: -
Identifier Source: org_study_id
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