CRITICALLY APPRAISED PAPER (CAP) Shin, J., Bog Park, S., & Ho Jang, S. (2015). Effects of game-based virtual reality on healthrelated quality of life in chronic stroke patients: A randomized, controlled study. Computers in Biology and Medicine, 63, 92 98. http://dx.doi.org/10.1016/j.compbiomed.2015.03.011 CLINICAL BOTTOM LINE: This study evaluated the effects of game-based virtual reality (VR) rehabilitation plus conventional occupational therapy on improving health-related quality of life (HRQOL), depression, and upper extremity function. Because VR has been suggested to provide highintensity, repetitive, and task-specific training, the researchers sought to determine whether game-based VR rehabilitation plus conventional occupational therapy was a more effective approach to poststroke rehabilitation than conventional occupational therapy alone. Participants in the study received either a combination of game-based VR rehabilitation and conventional occupational therapy or conventional occupational therapy alone. The results of the study indicate that, among patients with chronic hemiparetic stroke, conventional occupational therapy plus VR rehabilitation had specific positive effects on HRQOL, depression, and upper extremity function. The researchers found a statistically significant improvement in role limitation due to emotional problems in the group receiving VR rehabilitation plus conventional occupational therapy. A significant improvement was also indicated in role limitation due to physical problems in the same group. These findings imply that VR rehabilitation can be used to decrease role limitations, which is essential in the use of a top-down approach to occupational therapy. The authors suggested that VR rehabilitation, because of its immersive and motivating capabilities, functions in a special capacity in reducing physical limitations and improving quality of life in patients with chronic hemiparetic stroke. Overall, the researchers performed a valid randomized controlled study, attempting to limit biases when possible. They used trained therapists to administer the therapy. However, the study does not indicate whether any of the participants were receiving cotreatment, and the small sample size could be a hindrance to the number of significant differences noted in the results. Yet the results of the study do suggest that in occupational therapy, VR could be beneficial in either an inpatient or an outpatient rehabilitation setting. RESEARCH OBJECTIVE(S) List study objectives. Determine the effectiveness of game-based VR rehabilitation plus conventional occupational therapy, compared with the same amount of conventional occupational therapy alone, on 1
improving HRQOL, depression, and upper extremity function in adults with chronic hemiparesis after stroke DESIGN TYPE AND LEVEL OF EVIDENCE: Level I: Randomized controlled trial SAMPLE SELECTION How were subjects recruited and selected to participate? Please describe. Participants were recruited between January 2012 and March 2014 from one university hospital and one rehabilitation hospital after having a first-time stroke resulting in chronic hemiparetic upper limb dysfunction. Participants were adults aged 18 or older who were randomly divided into control and intervention groups according to a computer-generated randomization schedule in a 1:1 ratio. All participants provided written informed consent. Inclusion Criteria Participants were considered eligible if they had Medical Research Council Scale scores of 2 (when in a gravity-reduced position, able to move extremity the full range of motion) and 4 (able to move extremity against gravity through the full range of motion with moderate resistance). They also needed to have Brunnstrom motor recovery stage scores for the proximal upper extremity of 2 (after stage of flaccidity, limb synergies emerge and spasticity appears) and 5 (spasticity decreases, and moderate independence from limb synergies is seen). Exclusion Criteria Any potential participants were excluded if they had a severe cognitive impairment or aphasia, preexisting mental illness or arm impairment, difficulty in sitting for 30 min, or uncontrolled medical illness. SAMPLE CHARACTERISTICS N= (Number of participants taking part in the study) 35; dropout = 3 (9%) #/ (%) Male 24 (69%) #/ (%) Female 11 (31%) Ethnicity NR Disease/disability diagnosis Chronic hemiparetic upper limb dysfunction, secondary to first-time stroke INTERVENTION(S) AND CONTROL GROUPS Group 1: Occupational therapy only Brief description of the intervention This group received 30 min of conventional occupational therapy, plus an additional 30 min of occupational therapy, for a total of 1 hr. 2
How many participants in the group? Where did the intervention take place? Who Delivered? How often? For how long? The conventional occupational therapy consisted of range of motion and strengthening exercises for the affected limb, training for activities of daily living, and tabletop activities. The therapy was designed to promote the use of the affected limb and movement of the trunk, dependent on the functional status of the patient, and improve compromised motions, such as reaching, grasping, catching, and wrist flexion or extension. The difficulty of the therapy was adjusted by the occupational therapist, who controlled the target s placement or weight or the task speed. 17 NR The additional 30-min occupational therapy session was conducted variably by two trained occupational therapists who were exclusively dedicated to this study. Outcomes were evaluated by a trained and blinded outcome assessor who performed all assessments. Therapy took place 5 days/week for a total of 1 hr/day. The intervention lasted for 4 weeks. Group 2: VR plus occupational therapy group Brief description of the intervention How many participants in the group? Where did the intervention take place? This group received 30 min of conventional occupational therapy plus 30 min of game-based VR rehabilitation with the RehabMaster system. The conventional occupational therapy was the same as for the occupational therapy only group. VR through the RehabMaster system consisted of 10 min of rehabilitation training and 20 min of rehabilitation games; selected by the occupational therapist, these aimed to encourage active arm and trunk movements and promote successful rehabilitation. During the VR, the participant sat upright in a chair in front of the monitor and depth sensor and moved his or her upper limb or trunk according to the training the occupation therapist had chosen to address specific functional deficits. By manipulating range of motion; speed of activity; or number, size, location, speed, or trajectories of the targets, the therapists were able to adjust the difficulty level of the VR rehabilitation. 18 NR 3
Who Delivered? How often? For how long? The 30-min VR session was conducted variably by two trained occupational therapists who were exclusively dedicated to this study. Outcomes were evaluated by a trained and blinded outcome assessor who performed all assessments. Therapy took place 5 days/week for a total of 1 hr/day. The intervention lasted for 4 weeks. Intervention Biases: Check yes, no, or NR and explain, if needed. Contamination: The study does not specifically indicate whether the researchers controlled for the possibility that the control group members might have received VR therapy elsewhere. Co-intervention: Timing: Site: The researchers did not state whether the participants were receiving any other forms of therapy outside of the research study. This study lacks a follow-up, which would have indicated whether the results of the study were long lasting or temporary. Also, although all participants had chronic hemiparesis, no indication is given as to the exact length of time from stroke onset to the time therapy was received. Use of different therapists to provide intervention: The additional occupational therapy or VR was conducted by two trained therapists, dedicated exclusively to this study. MEASURES AND OUTCOMES Complete for each measure relevant to occupational therapy: Measure 1: Name/type of Korean version of the Short Form Health Survey (SF-36) measure used: What outcome was measured? Assessment measured HRQOL in eight of the domains of the SF-36: physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. 4
reliable? valid? When is the measure used? Measure 2: Name/type of measure used: What outcome was measured? reliable? valid? When is the measure used? Measure 3: Name/type of measure used: What outcome was measured? reliable? valid? When is the measure used? The participants were pretested at the initial visit and posttested at the conclusion of the intervention, 1 month later. Korean version of Hamilton Depression Rating Scale (HAMD) Assessment measures depression in participants The participants were pretested at the initial visit and posttested at the conclusion of the intervention, 1 month later. Upper extremity Fugl Meyer Assessment (FMA) Measures upper limb function The participants were given the assessment at the initial visit and posttested at the conclusion of the intervention, 1 month later. Measurement Biases Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. Recall or memory bias. Check yes, no, or NR, and if yes, explain. Both the SF-36 and the HAMD are survey assessments. Although the SF-36 is valid and reliable and the HAMD is valid, there is the possibility of recall bias, because the participants might not have replied to the selfreport questions in full honesty. RESULTS List key findings based on study objectives 5
Include statistical significance where appropriate (p < 0.05) Include effect size if reported Statistical analyses were performed with SPSS software; differences with p <.05 were considered statistically significant. The Kolmogorov Smirnov test evaluated the normality of the data. To assess the intergroup and intragroup data, the authors used nonparametric tests. Changes over time were analyzed with the Wilcoxon signed-rank test, and the two-tailed Mann Whitney U test was used to compare the intergroup differences at baseline and at the end of the study. No significant differences were found at baseline between the groups in terms of age, sex, duration from stroke onset, handedness, affected side, HAMD score, FMA score, and all of the SF-36 items (except mental health). The VR plus occupational therapy group displayed a statistically significant improvement, compared with baseline, in role limitation due to emotional problems (p =.047). A statistically significant difference between the VR plus occupational therapy group and the occupational therapy only group was observed for role limitation due to physical problems (p =.031). Although a significant difference was not shown, vitality improved in the VR plus occupational therapy group, compared with the occupational therapy only group (p =.065). Although no intergroup differences were observed, compared with baseline, statistically significant improvements in HAMD and FMA scores were observed in both groups. Was this study adequately powered (large enough to show a difference)? Check yes, no, or NR, and if no, explain. The number of participants after dropout was 32, a small participant population. The researchers noted the limitation and stated that a similar study reported that 96 participants per group are required to determine significant differences in upper extremity FMA scores. Were appropriate analytic methods used? Check yes, no, or NR, and if no, explain. Were statistics appropriately reported (in written or table format)? Check yes or no, and if no, explain. Was the percent/number of subjects/participants who dropped out of the study reported? Limitations: What are the overall study limitations? 6
The researchers reported four limitations to the study. The first limitation is the time from stroke onset to enrollment in the research study. Most participants experienced their stroke 6 months prior to enrollment, with chief complaints being motor-related functional impairments. Therefore, a direct comparison of VR-based rehabilitation and conventional occupational therapy could not be conducted. Second, the SF-36 has been questioned when used with participants with specific diseases; despite this, the researchers used the assessment. To provide some consistency, they administered the SF-36 in a standardized face-to-face interview, because poor completion rates are associated with mailed questionnaires. Another limitation of this study is that the researchers did not perform follow-up evaluations, which confines the results to shortterm effects only. Last, potentially significant results might have been compromised by the small participation sample. CONCLUSIONS State the authors conclusions related to the research objectives. The authors concluded that when combined with conventional occupational therapy, gamebased VR rehabilitation does provide improvements in specific HRQOL items, depression, and upper extremity function. They also determined that the benefits achieved through combined game-based VR rehabilitation and occupational therapy may not be achievable through conventional occupational therapy alone. The authors suggested that game-based VR rehabilitation may play a unique role in addressing the physical limitations and quality of life of patients with chronic stroke. This work is based on the evidence-based literature review completed in November 2015 by Lindsay Kozumplik, OTS, and Kelly Erickson PhD, OTR/L, Faculty Advisor, College of Saint Scholastica. CAP Worksheet adapted from Critical Review Form Quantitative Studies. Copyright 1998, by M. Law, D. Stewart, N. Pollack, L. Letts, J. Bosch, & M. Westmorland, McMaster University. Used with permission. For personal or educational use only. All other uses require permission from AOTA. Contact: www.copyright.com 7