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Xbox Kinect™ Training for Stroke Rehabilitation

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Xbox Kinect™ training
Conventional rehabilitation
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Rehabilitation, Serious games, Virtual reality, Xbox Kinect™

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • First-time ischemic or hemorrhagic stroke occurring in the last 9 months
  • Between 18 and 80 years of age
  • Brunnstrom motor recovery stage in the affected upper extremity ≥ 3
  • Ability to understand and follow simple explanations and commands
  • Mini-Mental State Examination score of ≥ 24

Exclusion Criteria:

  • History of epilepsy or seizure (except childhood febrile seizures)
  • Arthritis or pain restricting the repetitive training of the affected upper extremity
  • Severe aphasia
  • Neglect phenomena
  • Cognitive or psychiatric disorders
  • ≥ Grade 3 spasticity in the affected upper extremity according to Modified Ashworth Scale
  • Medical conditions which may affect physical performance or the physical activity may become unsafe (unstable angina, myocardial infarction within the last 3 months, uncontrolled blood pressure, pulmonary disease, etc.)
  • Participation in another clinical trial

Sites / Locations

  • Ankara University Faculty of Medicine, Cebeci Research and Application Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Xbox Kinect™ training group

Conventional rehabilitation group

Arm Description

60 minutes/day, 5 days/week, 4 weeks (20 sessions) conventional rehabilitation program plus 60 minutes/day, 5 days/week, 4 weeks (20 sessions) Xbox Kinect™ upper extremity training. Two games both of which require using upper extremities, were chosen and each game was played for 30 minutes per session.

60 minutes/day, 5 days/week, 4 weeks (20 sessions) conventional rehabilitation program only. The treatment protocol was individualized according to the goals which were determined depending on each patient's needs and functional level.

Outcomes

Primary Outcome Measures

Treatment attendance ratios
A feasibility outcome. The proportion of the completed training time to the planned training time.
Number of patients with adverse events
A safety outcome.

Secondary Outcome Measures

Box and Blocks Test
Gross manual dexterity
Wolf Motor Function Test
Motor function of the upper extremity
Functional Independence Measure
Self-care subscale of FIM will be used to evaluate the upper extremity related functional independence level
Brunnstrom Motor Assessment Scale
Motor recovery of the upper extremity
Patient feedback survey
Participant's opinions related to ease-of-use and enjoyment of the game system, pain or fatigue during or after the training, duration of sessions, contribution to recovery, using as a treatment approach and suggestion to the other patients.
Borg 10 Point Scale
A safety outcome. Rating of perceived exertion and fatigue.

Full Information

First Posted
April 28, 2016
Last Updated
April 29, 2016
Sponsor
Ankara University
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1. Study Identification

Unique Protocol Identification Number
NCT02759328
Brief Title
Xbox Kinect™ Training for Stroke Rehabilitation
Official Title
Clinical Feasibility of the Xbox Kinect™ Training for Stroke Rehabilitation: a Single Blind Randomized Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Commercial interactive game consoles including the Nintendo Wii™ and the Sony Playstation Eyetoy™ have been used in stroke rehabilitation with variable success and seemed to be safe, feasible and effective treatment options. The more recently released Xbox Kinect™ game console has superiorities to the others such as not requiring any special controller and having a more sensitive sensor which provides more accurate motion-capturing. However, there is limited evidence on clinical utility of the Xbox Kinect™ in stroke rehabilitation. Currently it has been designed for physically and mentally healthy people just like previous consoles. Therefore, the safety and feasibility of the system should be evaluated in first place before using it as an alternative or adjunctive training method in stroke patients. To the best of our knowledge, no studies have evaluated the clinical feasibility of the Xbox Kinect™ in stroke rehabilitation. The aim of this pilot study was to evaluate the feasibility and safety of the Xbox Kinect™ training of upper extremity in subacute stroke rehabilitation. The secondary aim was to evaluate its efficacy on upper extremity motor and functional recovery.
Detailed Description
This study was planned as a single-blind, randomized controlled, pilot trial. It was approved by the Ankara University Faculty of Medicine Ethics Committee and was conducted in accordance with the Declaration of Helsinki. Stroke patients who were hospitalized for inpatient rehabilitation at the Ankara University Faculty of Medicine, Cebeci Research and Application Hospital, Physical Medicine and Rehabilitation Clinic from December 2012 to March 2014, were assessed to determine their eligibility for the study. All patients were diagnosed with stroke by a neurologist according to World Health Organization stroke definition and confirmed by neuroimaging (computed tomography or magnetic resonance imaging). All patients who fulfilled the inclusion criteria received a detailed explanation of the study and written informed consent was obtained from all participants prior to enrollment. Patient characteristics were collected at baseline including socio-demographic features (age, gender, marital status, educational level, vocation), stroke type, time from stroke onset to enrollment, affected side, handedness, comorbid conditions, spasticity grade (according to Modified Ashworth Scale) and motor recovery stages according to Brunnstrom Motor Assessment Scale (BMAS). Affected upper extremity was examined using the Box and Blocks Test (BBT) and the Wolf Motor Function Test (WMFT). Baseline level of functional independence was assessed using the Functional Independence Measure (FIM). Participants were randomly allocated to two groups; the experimental group and the control group. Both the experimental group and the control group received a conventional rehabilitation program for 4 weeks (60 minutes/day, 5 days/week). The experimental group underwent an additional training with the Xbox Kinect™ for 4 weeks (60 minutes/day, 5 days/week). The primary outcome measures of this pilot study are related to feasibility and safety of the Xbox Kinect™ in subacute stroke rehabilitation. Treatment attendance ratio, which is the proportion of the completed training time to the planned training time, was used as the primary feasibility outcome. The treatment attendance ratios were calculated for three different measurements: total training time, training time per session and the number of sessions. In addition, the result obtained from patient feedback survey was also used as a feasibility outcome. The ratio of patients who had adverse events related to the intervention or any serious adverse event during the study was defined as the primary safety outcome. Rating of perceived exertion measured according to the Borg 10 Point Scale was also used as a safety outcome. To determine the efficacy of the intervention, BBT, WMFT, FIM, BMAS were used as secondary outcome measures. Mean, standard deviation, median, min-max and percentile values were calculated for the socio-demographic and clinical features, primary and secondary outcome measures by descriptive statistics. The Shapiro-Wilk test was used for normality testing. The Wilcoxon signed rank test was used to evaluate differences within groups. The Mann Whitney U test was used to evaluate differences between groups. P value of less than .05 was considered as statistically significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Rehabilitation, Serious games, Virtual reality, Xbox Kinect™

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Xbox Kinect™ training group
Arm Type
Experimental
Arm Description
60 minutes/day, 5 days/week, 4 weeks (20 sessions) conventional rehabilitation program plus 60 minutes/day, 5 days/week, 4 weeks (20 sessions) Xbox Kinect™ upper extremity training. Two games both of which require using upper extremities, were chosen and each game was played for 30 minutes per session.
Arm Title
Conventional rehabilitation group
Arm Type
Active Comparator
Arm Description
60 minutes/day, 5 days/week, 4 weeks (20 sessions) conventional rehabilitation program only. The treatment protocol was individualized according to the goals which were determined depending on each patient's needs and functional level.
Intervention Type
Behavioral
Intervention Name(s)
Xbox Kinect™ training
Intervention Description
Xbox Kinect™ (Xbox 360, Microsoft, United States) game console which is one of the commercial interactive game consoles was used. It was comprised of 3 components; Kinect™ sensor, Xbox 360™ game console and 42 inch Liquid crystal display (LCD) television.
Intervention Type
Behavioral
Intervention Name(s)
Conventional rehabilitation
Intervention Description
The conventional rehabilitation program consisted of passive and active range of motion exercises, therapeutic stretching, muscle strengthening, neurophysiologic exercises, sitting, standing, balance and gait exercises, occupational therapy and activities of daily living training such as eating, grooming, dressing, toileting and transfer.
Primary Outcome Measure Information:
Title
Treatment attendance ratios
Description
A feasibility outcome. The proportion of the completed training time to the planned training time.
Time Frame
Every training session during 4 weeks (total 20 sessions)
Title
Number of patients with adverse events
Description
A safety outcome.
Time Frame
Every training session during 4 weeks (total 20 sessions)
Secondary Outcome Measure Information:
Title
Box and Blocks Test
Description
Gross manual dexterity
Time Frame
Change from baseline at 4 weeks
Title
Wolf Motor Function Test
Description
Motor function of the upper extremity
Time Frame
Change from baseline at 4 weeks
Title
Functional Independence Measure
Description
Self-care subscale of FIM will be used to evaluate the upper extremity related functional independence level
Time Frame
Change from baseline at 4 weeks
Title
Brunnstrom Motor Assessment Scale
Description
Motor recovery of the upper extremity
Time Frame
Change from baseline at 4 weeks
Title
Patient feedback survey
Description
Participant's opinions related to ease-of-use and enjoyment of the game system, pain or fatigue during or after the training, duration of sessions, contribution to recovery, using as a treatment approach and suggestion to the other patients.
Time Frame
At 4 weeks (after completion of all treatment sessions (total 20 sessions))
Title
Borg 10 Point Scale
Description
A safety outcome. Rating of perceived exertion and fatigue.
Time Frame
Every training session during 4 weeks (total 20 sessions)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: First-time ischemic or hemorrhagic stroke occurring in the last 9 months Between 18 and 80 years of age Brunnstrom motor recovery stage in the affected upper extremity ≥ 3 Ability to understand and follow simple explanations and commands Mini-Mental State Examination score of ≥ 24 Exclusion Criteria: History of epilepsy or seizure (except childhood febrile seizures) Arthritis or pain restricting the repetitive training of the affected upper extremity Severe aphasia Neglect phenomena Cognitive or psychiatric disorders ≥ Grade 3 spasticity in the affected upper extremity according to Modified Ashworth Scale Medical conditions which may affect physical performance or the physical activity may become unsafe (unstable angina, myocardial infarction within the last 3 months, uncontrolled blood pressure, pulmonary disease, etc.) Participation in another clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haydar GOK, Professor
Organizational Affiliation
Ankara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara University Faculty of Medicine, Cebeci Research and Application Hospital
City
Ankara
ZIP/Postal Code
06620
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19164398
Citation
Edmans J, Gladman J, Hilton D, Walker M, Sunderland A, Cobb S, Pridmore T, Thomas S. Clinical evaluation of a non-immersive virtual environment in stroke rehabilitation. Clin Rehabil. 2009 Feb;23(2):106-16. doi: 10.1177/0269215508095875.
Results Reference
background
PubMed Identifier
17613000
Citation
Crosbie JH, Lennon S, Basford JR, McDonough SM. Virtual reality in stroke rehabilitation: still more virtual than real. Disabil Rehabil. 2007 Jul 30;29(14):1139-46; discussion 1147-52. doi: 10.1080/09638280600960909.
Results Reference
background
PubMed Identifier
25927099
Citation
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.
Results Reference
background
PubMed Identifier
25586794
Citation
Paquin K, Ali S, Carr K, Crawley J, McGowan C, Horton S. Effectiveness of commercial video gaming on fine motor control in chronic stroke within community-level rehabilitation. Disabil Rehabil. 2015;37(23):2184-91. doi: 10.3109/09638288.2014.1002574. Epub 2015 Jan 14.
Results Reference
background
PubMed Identifier
15679945
Citation
Sveistrup H. Motor rehabilitation using virtual reality. J Neuroeng Rehabil. 2004 Dec 10;1(1):10. doi: 10.1186/1743-0003-1-10.
Results Reference
background
PubMed Identifier
24710975
Citation
Pietrzak E, Cotea C, Pullman S. Using commercial video games for upper limb stroke rehabilitation: is this the way of the future? Top Stroke Rehabil. 2014 Mar-Apr;21(2):152-62. doi: 10.1310/tsr2102-152.
Results Reference
background
PubMed Identifier
24661797
Citation
Thomson K, Pollock A, Bugge C, Brady M. Commercial gaming devices for stroke upper limb rehabilitation: a systematic review. Int J Stroke. 2014 Jun;9(4):479-88. doi: 10.1111/ijs.12263. Epub 2014 Mar 24.
Results Reference
background
PubMed Identifier
24668359
Citation
Bower KJ, Clark RA, McGinley JL, Martin CL, Miller KJ. Clinical feasibility of the Nintendo Wii for balance training post-stroke: a phase II randomized controlled trial in an inpatient setting. Clin Rehabil. 2014 Sep;28(9):912-23. doi: 10.1177/0269215514527597. Epub 2014 Mar 25.
Results Reference
background
PubMed Identifier
23366134
Citation
Pastor I, Hayes HA, Bamberg SJ. A feasibility study of an upper limb rehabilitation system using Kinect and computer games. Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:1286-9. doi: 10.1109/EMBC.2012.6346173.
Results Reference
background
PubMed Identifier
23920709
Citation
Hors-Fraile S, Browne J, Brox E, Evertsen G. Evaluation of sensors for inputting data in exergames for the elderly. Stud Health Technol Inform. 2013;192:935.
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
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
PubMed Identifier
24990008
Citation
Fernandes AB, Passos JO, Brito DP, Campos TF. Comparison of the immediate effect of the training with a virtual reality game in stroke patients according side brain injury. NeuroRehabilitation. 2014;35(1):39-45. doi: 10.3233/NRE-141105.
Results Reference
background
PubMed Identifier
25206611
Citation
Bao X, Mao Y, Lin Q, Qiu Y, Chen S, Li L, Cates RS, Zhou S, Huang D. Mechanism of Kinect-based virtual reality training for motor functional recovery of upper limbs after subacute stroke. Neural Regen Res. 2013 Nov 5;8(31):2904-13. doi: 10.3969/j.issn.1673-5374.2013.31.003.
Results Reference
background
PubMed Identifier
26311925
Citation
Song GB, Park EC. Effect of virtual reality games on stroke patients' balance, gait, depression, and interpersonal relationships. J Phys Ther Sci. 2015 Jul;27(7):2057-60. doi: 10.1589/jpts.27.2057. Epub 2015 Jul 22.
Results Reference
background
PubMed Identifier
24024033
Citation
Rajaratnam BS, Gui Kaien J, Lee Jialin K, Sweesin K, Sim Fenru S, Enting L, Ang Yihsia E, Keathwee N, Yunfeng S, Woo Yinghowe W, Teo Siaoting S. Does the Inclusion of Virtual Reality Games within Conventional Rehabilitation Enhance Balance Retraining after a Recent Episode of Stroke? Rehabil Res Pract. 2013;2013:649561. doi: 10.1155/2013/649561. Epub 2013 Aug 18.
Results Reference
background
PubMed Identifier
3809245
Citation
Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
Results Reference
background
PubMed Identifier
10489001
Citation
Gregson JM, Leathley M, Moore AP, Sharma AK, Smith TL, Watkins CL. Reliability of the Tone Assessment Scale and the modified Ashworth scale as clinical tools for assessing poststroke spasticity. Arch Phys Med Rehabil. 1999 Sep;80(9):1013-6. doi: 10.1016/s0003-9993(99)90053-9.
Results Reference
background
PubMed Identifier
8024419
Citation
Desrosiers J, Bravo G, Hebert R, Dutil E, Mercier L. Validation of the Box and Block Test as a measure of dexterity of elderly people: reliability, validity, and norms studies. Arch Phys Med Rehabil. 1994 Jul;75(7):751-5.
Results Reference
background
PubMed Identifier
12837123
Citation
Ahmed S, Mayo NE, Higgins J, Salbach NM, Finch L, Wood-Dauphinee SL. The Stroke Rehabilitation Assessment of Movement (STREAM): a comparison with other measures used to evaluate effects of stroke and rehabilitation. Phys Ther. 2003 Jul;83(7):617-30.
Results Reference
background
PubMed Identifier
2707361
Citation
Wolf SL, Lecraw DE, Barton LA, Jann BB. Forced use of hemiplegic upper extremities to reverse the effect of learned nonuse among chronic stroke and head-injured patients. Exp Neurol. 1989 May;104(2):125-32. doi: 10.1016/s0014-4886(89)80005-6.
Results Reference
background
PubMed Identifier
16093410
Citation
Wolf SL, Thompson PA, Morris DM, Rose DK, Winstein CJ, Taub E, Giuliani C, Pearson SL. The EXCITE trial: attributes of the Wolf Motor Function Test in patients with subacute stroke. Neurorehabil Neural Repair. 2005 Sep;19(3):194-205. doi: 10.1177/1545968305276663.
Results Reference
background
PubMed Identifier
11387578
Citation
Morris DM, Uswatte G, Crago JE, Cook EW 3rd, Taub E. The reliability of the wolf motor function test for assessing upper extremity function after stroke. Arch Phys Med Rehabil. 2001 Jun;82(6):750-5. doi: 10.1053/apmr.2001.23183.
Results Reference
background
PubMed Identifier
11386402
Citation
Kucukdeveci AA, Yavuzer G, Elhan AH, Sonel B, Tennant A. Adaptation of the Functional Independence Measure for use in Turkey. Clin Rehabil. 2001 Jun;15(3):311-9. doi: 10.1191/026921501676877265.
Results Reference
background
PubMed Identifier
7154893
Citation
Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
Results Reference
background
PubMed Identifier
18256679
Citation
Dobkin BH. Training and exercise to drive poststroke recovery. Nat Clin Pract Neurol. 2008 Feb;4(2):76-85. doi: 10.1038/ncpneuro0709.
Results Reference
background
PubMed Identifier
26233677
Citation
Bower KJ, Louie J, Landesrocha Y, Seedy P, Gorelik A, Bernhardt J. Clinical feasibility of interactive motion-controlled games for stroke rehabilitation. J Neuroeng Rehabil. 2015 Aug 2;12:63. doi: 10.1186/s12984-015-0057-x.
Results Reference
background
PubMed Identifier
20508185
Citation
Saposnik G, Teasell R, Mamdani M, Hall J, McIlroy W, Cheung D, Thorpe KE, Cohen LG, Bayley M; Stroke Outcome Research Canada (SORCan) Working Group. Effectiveness of virtual reality using Wii gaming technology in stroke rehabilitation: a pilot randomized clinical trial and proof of principle. Stroke. 2010 Jul;41(7):1477-84. doi: 10.1161/STROKEAHA.110.584979. Epub 2010 May 27.
Results Reference
background

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Xbox Kinect™ Training for Stroke Rehabilitation

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