Clinical feasibility of interactive motion-controlled games for stroke rehabilitation

Background Active gaming technologies, including the Nintendo Wii and Xbox Kinect, have become increasingly popular for use in stroke rehabilitation. However, these systems are not specifically designed for this purpose and have limitations. The aim of this study was to investigate the feasibility of using a suite of motion-controlled games in individuals with stroke undergoing rehabilitation. Methods Four games, which utilised a depth-sensing camera (PrimeSense), were developed and tested. The games could be played in a seated or standing position. Three games were controlled by movement of the torso and one by upper limb movement. Phase 1 involved consecutive recruitment of 40 individuals with stroke who were able to sit unsupported. Participants were randomly assigned to trial one game during a single session. Sixteen individuals from Phase 1 were recruited to Phase 2. These participants were randomly assigned to an intervention or control group. Intervention participants performed an additional eight sessions over four weeks using all four game activities. Feasibility was assessed by examining recruitment, adherence, acceptability and safety in both phases of the study. Results Forty individuals (mean age 63 years) completed Phase 1, with an average session time of 34 min. The majority of Phase 1 participants reported the session to be enjoyable (93 %), helpful (80 %) and something they would like to include in their therapy (88 %). Sixteen individuals (mean age 61 years) took part in Phase 2, with an average of seven 26-min sessions over four weeks. Reported acceptability was high for the intervention group and improvements over time were seen in several functional outcome measures. There were no serious adverse safety events reported in either phase of the study; however, a number of participants reported minor increases in pain. Conclusions A post-stroke intervention using interactive motion-controlled games shows promise as a feasible and potentially effective treatment approach. This paper presents important recommendations for future game development and research to further explore long-term adherence, acceptability, safety and efficacy. Trial registration Australian and New Zealand Clinical Trials Registry (ACTRN12613000220763)

safety in both phases of the study. 23 Results: Forty individuals (mean age 63 years) completed Phase 1, with an average session time of 34 min. The 24 majority of Phase 1 participants reported the session to be enjoyable (93 %), helpful (80 %) and something they 25 would like to include in their therapy (88 %). Sixteen individuals (mean age 61 years) took part in Phase 2, with an 26 average of seven 26-min sessions over four weeks. Reported acceptability was high for the intervention group and 27 improvements over time were seen in several functional outcome measures. There were no serious adverse safety 28 events reported in either phase of the study; however a number of participants reported minor increases in pain. 29 Conclusions: A post-stroke intervention using interactive motion-controlled games shows promise as a feasible 30 and potentially effective treatment approach. This paper presents important recommendations for future game 31 development and research to further explore long-term adherence, acceptability, safety and efficacy. 32 Trial registration: Australian and New Zealand Clinical Trials Registry ( Q3 ACTRN12613000220763) 33 Background 34 Stroke is a leading cause of disability world-wide [1]. 35 Common stroke-related impairments, such as loss of 36 strength, sensation and coordination, lead to difficulties 37 in walking [2], balance [3], and upper limb function [4]. 38 This can have a significant impact on an individual's 39 independence, safety and quality of life [5,6]. Therefore, 40 the implementation of effective interventions to optimise 41 recovery is critical. 42 Physical therapy has been shown to aid recovery after

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Features were built into the games to allow for object-220 ive monitoring and feedback on performance. All four 221 games had scoring and time counts as previously de-222 scribed. Additionally, a small depth representation of the 223 user could be seen in the upper left corner (Fig. 1). This 224 allowed immediate feedback on movement; however, 225 given the focus on the game activity it was unlikely to be 226 used as a key feedback mechanism. Simple auditory 227 feedback was provided in each game in response to either 228 successful or unsuccessful movements or 'hits'. . Feasibility outcomes addressed: 1) recruitment 256 rate and willingness to participate; 2) adherence, through 257 documentation of session attendance and length; 3) ac-258 ceptability, using 5-point Likert scales [34] to rate enjoy-259 ment (from 1: "really didn't enjoy" to 5: "really enjoyed" in 260 response to "I enjoyed my treatment session") and per-261 ceived helpfulness (from 1: "really not helpful" to 5: "really 262 helpful" in response to "I thought my session today was 263 helpful for my recovery"), and 'yes/no' response for con-264 tinued use of the game; and 4) safety, through documenta-265 tion of any adverse events, including pre-and post-session  sures at baseline for both Phase 1 and Phase 2 participants 322 were summarised using descriptive statistics. The normal-323 ity of data distribution was evaluated using Shapiro-Wilk 324 tests. One-way analysis of variance (ANOVA) or Kruskall-325 Wallis tests were used to assess baseline differences 326 between the four groups in Phase 1. Independent t-tests, 327 Mann-Whitney U tests or Chi square tests were used to 328 assess differences in baseline characteristics between 329 the two Phase 2 groups, and between the Phase 1 and 330 Phase 2 groups.

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Descriptive statistics were used to summarise ses-332 sion times, times spent in each game activity, stand-333 ing versus sitting times, and difficulty levels reached. 334 Likert ratings of enjoyment and perceived helpfulness 335 were reported descriptively for participants in both 336 phases. Kruskall-Wallis tests were used to assess dif-337 ferences in acceptability ratings between the four Phase 1 338 groups. Participant feedback was compiled by a member 339 of the research team and key themes and comments 340 described.

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Changes in pain and fatigue were reported descrip-342 tively for participants in both phases. One-way ANOVA 343 were used to examine differences in changes in pain and 344 fatigue within and between the four Phase 1 groups. 345 Borg ratings of perceived exertion were compared be-346 tween Phase 1 groups using a Kruskal-Wallis test, and 347 between Phase 1 and Phase 2 groups using a Mann-348 Whitney U test.      422 Acceptability 423 Phase 1: The majority of participants reported the ses-424 sions to be enjoyable (92.5 % rated "enjoyed" or "really 425 enjoyed" on the 5-point Likert scale) and felt the session 426 was helpful for their recovery (80 % rated "helpful" or 427 "really helpful"). One participant did not find the game-428 based session to be enjoyable or helpful, whereas others 429 were neutral in their response. When asked whether 430 they would like to continue the game intervention as 431 part of their ongoing therapy, 87.5 % responded 'Yes'. 432 There were no significant differences in acceptability 433 ratings of enjoyment (P = 0.74) or perceived helpfulness 434 (P = 0.29) between the four games in Phase 1.      Phase 2: Six of eight Phase 2 participants reported an 503 increase in pain (ranging from 1 to 8 points) in 13 of 58 504 total sessions. Pain reductions were seen in 10 sessions 505 (ranging from 1 to 2 points). The highest rating of 506 increased pain was reported in the participant who 507 discontinued the study after four sessions due to neck 508 discomfort. Although these symptoms were likely exac-509 erbated by study participation, they were also reported 510 during their usual physiotherapy sessions. Furthermore, 511 one participant in Phase 2 complained of dizziness, 512 which increased by 2 to 3 points (on an 11-point scale) 513 during each session and limited their study session dur-514 ation. This dizziness was also reported during their usual 515 physiotherapy sessions and was related to their type 516 of stroke.

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Overall pre to post-session fatigue in Phase 1 par-518 ticipants increased by a mean (SD) of 1.6 (2.4) on an 519 11-point VAS (P < 0.001). Fatigue increase (ranging from 520 1 to 8 points) occurred in 22 of 40 Phase 1 participants. 521 Three participants reported a decrease in fatigue, ranging 522 from 1 to 2 points. There was no significant difference 523 between change in fatigue scores between the four game 524 groups in Phase 1 (P = 0.41). Similarly, Phase 2 partici-525 pants were found to have fatigue increases in 25 of the 58 526 total sessions (ranging from 1 to 5 points and re-527 ported by all eight participants), and decreases in 528 three sessions (ranging from 1 to 3 points and reported by 529 three individual participants). The post-session Borg 530 rating of perceived exertion was a median (IQR) of 531 11.0 (9.5-13) in Phase 1, with no significant differ-532 ences between the four groups (P = 0.45). Phase 2 533 participants reported a median (IQR) of11.9 (8.9-13.1), 534 which was not significantly different than Phase 1 ratings 535 (P = 0.97).
536 Phase 2 functional outcomes 537 Outcome data for Phase 2 are presented in Table   Q6 3. 538 There were no significant between-group differences at 539 baseline or at 4 weeks on any outcome measure. The 540 intervention group improved significantly over time on 541 several outcomes including FIM transfers (P = 0.04), FIM 542 mobility (P = 0.03), and the 6-min walk test (P = 0.01). 543 There were no significant within-group changes in the 544 control group in any of the outcomes measures. A large 545 number of participants were unable to perform the Step 546 Test at either baseline or after 4 weeks (50 %; n = 8); and 547 the 6-min walk test at baseline (37.5 %; n = 6). The 548 number of usual therapy sessions (including physio-549 therapy, allied health assistant and exercise group ses-550 sions) received during the period of study participation 551 did not significantly differ between the two Phase 2 552 groups (mean (SD) session number 15.5 (10.4) and 12.3 553 (10.5) in the intervention and control group, respectively; 554 P = 0.54).

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This study found that a treatment approach utilising 3D 557 motion-tracking games was a feasible option for use in 558 people with stroke, with high levels of acceptability.   check if the tables and their corresponding table legends are captured and  presented appropriately. Q5 Table "2" was received; however, no citation was provided in the manuscript. Please provide the location of where to insert the citation in the main body of the text. Otherwise, kindly advise us on how to proceed. Please note that tables should be cited in ascending numerical order in the main body of the text. Q6 Table "3" was mentioned in the manuscript; however, no corresponding table body was provided. Please supply. Otherwise, kindly advise us on how to proceed. Please note that all figures or tables referring to elements of a separate manuscript must be spelt out rather than in numeric form to avoid confusion with in-text citations of tables within the manuscript.