Effects of Wearable Sensor Based Virtual Reality Game on Balance for Stroke

NCT04297774 | Completed

• 1 other identifier: TMU-JIRB N201912048
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Pablo is a new virtual reality (VR) game combined with wearable motion sensor system which can targeted intervention in an interactive environment, immediate and sensitive feedback about the user's performance, a motivating effect due to game-based feature. Unlike commercial camera systems such as Kinect or force platforms, the systems require a continuous sightline or restrict the base of support which may increase risk of falling. Few of studies had investigated the rehabilitation effects on balance with Pablo for patients with stroke. The purpose of this study is to investigate the effects of virtual reality training through Pablo system in patients with chronic stroke.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale

  It is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.

  Change from Baseline to 9 weeks follow up

Secondary Outcomes (6)

• Functional reach test

  Change from Baseline to 9 weeks follow up

• Time up and go-cognition

  Change from Baseline to 9 weeks follow up

• Activities-specific Balance Confidence scale

  Change from Baseline to 9 weeks follow up

• Stroke Impact Scale-physical domain

  Change from Baseline to 9 weeks follow up

• Modified Physical Activity Enjoyment Scale

  Every training session during 18 sessions, total sessions continued to 9 weeks

Study Arms (2)

virtual reality group

EXPERIMENTAL

18 sessions of standard treatment plus virtual reality treatment.

Behavioral: virtual reality treatment; Behavioral: standard treatment

standard treatment group

ACTIVE COMPARATOR

18 sessions of standard treatment plus balance training.

Behavioral: standard treatment; Behavioral: balance training

Interventions

virtual reality treatment BEHAVIORAL

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.

virtual reality group

standard treatment BEHAVIORAL

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; virtual reality group

balance training BEHAVIORAL

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.

standard treatment group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients were included if they had first stroke with hemiplegia.
• Could stand for 5 minutes without support.
• Chronicity of \>6 months.
• Could understand instructions.
• Brunnstrom stage of LE ≥Ⅲ.

You may not qualify if:

• Patients who were aged \<20 years and \>75 years
• 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.

Sponsors & Collaborators

• Taipei Medical University Shuang Ho Hospital: lead

Study Sites (1)

Taipei Medical University Shuang Ho Hospital

Taipei, Taiwan

Location

Related Publications (19)

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  PMID: 18184932 BACKGROUND

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  PMID: 1088404 BACKGROUND

• 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.

  PMID: 24782894 BACKGROUND

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• Lange, B., S. Flynn, and A. Rizzo, Initial usability assessment of off-the-shelf video game consoles for clinical game-based motor rehabilitation. Physical Therapy Reviews, 2009. 14(5): p. 355.

  BACKGROUND

• 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.

  BACKGROUND

• de Haart M, Geurts AC, Huidekoper SC, Fasotti L, van Limbeek J. Recovery of standing balance in postacute stroke patients: a rehabilitation cohort study. Arch Phys Med Rehabil. 2004 Jun;85(6):886-95. doi: 10.1016/j.apmr.2003.05.012.

  PMID: 15179641 BACKGROUND

• 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.

  PMID: 22070602 BACKGROUND

• 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.

  PMID: 24456057 BACKGROUND

• 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.

  PMID: 27418760 BACKGROUND

• 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.

  PMID: 21651800 BACKGROUND

• 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.

  PMID: 20544153 BACKGROUND

• 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.

  PMID: 25927099 BACKGROUND

• Smith, C., et al., Can non-immersive virtual reality improve physical outcomes of rehabilitation? Physical Therapy Reviews, 2012. 17(1): p. 1-15.

  BACKGROUND

• 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.

  PMID: 24681826 BACKGROUND

• 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.

  PMID: 23872681 BACKGROUND

• 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.

  PMID: 7814786 BACKGROUND

• 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.

  PMID: 22502804 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hsinchieh Lee, master

  Taipei Medical University, Taiwan, R.O.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 5, 2020
• Study Start: May 2, 2020
• Primary Completion: May 30, 2021
• Study Completion: July 25, 2021
• Last Updated: September 29, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)