CRITICALLY APPRAISED PAPER (CAP) Kwon, J., Park, M., Yoon, I., & Park, S. (2012). Effects of virtual reality on upper extremity function and activities of daily living performance in acute stroke: A double-blind randomized clinical trial. Neurorehabilitation, 31(4), 379 385. http://dx.doi.org/10.3233/nre-2012-00807 CLINICAL BOTTOM LINE: This study was a double-blind randomized controlled trial aimed to determine the effectiveness of virtual reality (VR) therapy combined with conventional therapy (CT) during the acute stage following a stroke. The VR therapy in this study was intensive and used in conjunction with CT. The objective was to determine whether this form of combined therapy would improve upper extremity function and increase performance in activities of daily living (ADLs). The trial studied 26 adults who were placed in the VR group or the CT group. Improvement in use and function of the upper limb was measured by the Fugl Myer Assessment (FMA), the Manual Function Test (MFT), and the Korean version of the Modified Barthel Index (K-MBI). The results of the study show that the addition of VR therapy improved upper extremity function but did not improve performance in ADLs. The study examined CT with added VR therapy, which can improve upper extremity function; the motivation levels were unknown in this study; and the use of VR therapy is more of a home supplement and not a stand-alone intervention. Furthermore, the study indicates that continued research is needed to measure therapy motivation levels of the participants, increase the length of VR intervention, and evaluate the long-term progress of the participants. Given the nature of the VR system used, the researchers felt that clients might need increased time to transfer skills to realize the full improvement of upper limb function and the possibility of increased performance in ADLs. The study suggests that the improvements were most beneficial during intensive training in the acute stage of stroke. RESEARCH OBJECTIVE(S) List study objectives. To determine the effectiveness of the combination of VR therapy with CT on the function of upper extremities and ADLs in individuals during the acute phase of stroke rehabilitation DESIGN TYPE AND LEVEL OF EVIDENCE: Level I: double-blind randomized controlled trial 1
SAMPLE SELECTION How were subjects recruited and selected to participate? Please describe. From a general teaching hospital in Seoul, Republic of Korea, 26 participants (12 women and 14 men; mean age = 57.54 + 13.68) with hemiparetic stroke during the acute phase of rehabilitation were enrolled in this study. Inclusion Criteria Adults who were within a 3-month poststroke period Individuals with the capacity to understand and follow simple instructions Adults who demonstrated three grades on the Manual Muscle Test of elbow joint movement The ability to grasp and release the affected hand Ability to maintain standing or sitting position independently No visual deficit Exclusion Criteria NR SAMPLE CHARACTERISTICS N= (Number of participants taking part in the study) 26 #/ (%) Male 14/(54%) #/ (%) Female 12/(46%) Ethnicity NR Disease/disability diagnosis Stroke in acute stage of rehabilitation INTERVENTION(S) AND CONTROL GROUPS Add groups if necessary Group 1: Experimental group (VR therapy and CT) Brief description of the intervention How many participants in the group? Where did the intervention take place? Who Delivered? The authors implemented the IREX VR system, which uses a video camera, television monitor, cyber gloves, virtual objects, and scenes displayed on a large back display. Five games based on upper limb movement were selected: Bird and Ball, Drum, Coconutz, Soccer, and Conveyor games 13 Hospital One occupational therapist who was professionally familiar with VR 2
How often? For how long? intervention 30 min per day, 5 days per week. The 30 min per day of the VR intervention were in addition to the 70 min per day of the CT intervention for the control group. 4 weeks Group 2: Control group (CT only) Brief description of the intervention How many participants in the group? Where did the intervention take place? Who Delivered? How often? For how long? CT included gait training, balance training, tabletop activities, strengthening exercise of upper limb, and ADL training 13 Hospital Each individual s physical therapist and occupational therapist 70 min per day, 5 days per week 4 weeks Intervention Biases: Check yes, no, or NR and explain, if needed. Contamination: YES NO Co-intervention: YES NR Timing: Contamination did not occur, because the therapists carried out the prescribed interventions and evaluations and there were no instances reported of breaking the blind. No additional therapies or medications were reported as part of the study. Both groups received the designated interventions for 5 days per week for a relatively short period of 4 weeks. Because the VR therapy used was a game-based and not a reality-based program, transference of these skills might have taken longer for the effectiveness of the VR intervention to be fully attained. It is possible that the experimental group made improvements because they received more time for services in addition to CT. Site: 3
YES NR Use of different therapists to provide intervention: The control group consisted of individuals who received CT from their own occupational therapist and physical therapist. The experimental group consisted of individuals who received VR therapy and CT from one occupational therapist who was professionally familiar with VR intervention. MEASURES AND OUTCOMES Complete for each measure relevant to occupational therapy: Measure 1: Name/type of FMA measure used: What outcome was measured? reliable? valid? When is the measure used? The Upper Extremity subtest was used to examine the following: sensation, range of motion, reflexes, synergy, and fine and gross motor movements. Each movement is determined on a 3-point scale, and the total score for the upper extremity ranges from 0 to 60 points. The higher score reflects more function of upper limbs. YES NR Preintervention and postintervention Measure 2: Name/type of measure used: What outcome was measured? reliable? valid? When is the measure used? MFT Upper extremity function was measured in individuals who experienced a stroke. The MFT is composed of eight subtests that measure gross motor of upper limb (four subtests), grip (two subtests), and in-hand manipulation (two subtests). Each item is scored on a 3 9-point scale, with a total possible score of 32 points. Preintervention and postintervention 4
Measure 3: Name/type of measure used: What outcome was measured? reliable? valid? When is the measure used? K-MBI Among individuals recovering from a stroke, this assessment determines the level of independence in 10 subtests of ADL performance. The K- MBI has been restandardized from the MBI for Korean culture appropriateness. Preintervention and postintervention Measurement Biases Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. 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. YES NO Others (list and explain): NR RESULTS List key findings based on study objectives Include statistical significance where appropriate (p<0.05) Include effect size if reported 5
Experimental (VR) Group FMA scores at pretest and posttest showed significant improvement (p <.05). MFT scores at pretest and posttest showed significant improvement (p <.05). K-MBI scores at pretest and posttest in each group of ADL performance showed significant differences (p <.05). Control (CT) Group FMA scores at pretest and posttest showed significant improvement (p <.05). MFT scores at pretest and posttest showed no significant improvement (p >.05). K-MBI scores at pretest and posttest in each group of ADL performance showed significant differences (p <.05). The authors conducted an independent t test to compare the results between the experimental and control groups at both pretest and posttest. The FMA, MFT, and K- MBI scores between the VR and CT groups showed no significant statistical difference (p >.05). After the intervention in the VR and CT groups, the effect sizes of change in the outcome variables were within the medium range on the FMA (Cohen s d = 0.48 ~ 0.51) and within the large range on the K-BMI (Cohen s d = 1.02 ~ 1.29). Was this study adequately powered (large enough to show a difference)? Check yes, no, or NR, and if no, explain. YES NO This study had a small sample size of 26 patients. 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
Small sample size (26 individuals) Short-term study (4 weeks) Evaluation of subjective motivation was not conducted. CONCLUSIONS State the authors conclusions related to the research objectives. The authors concluded that VR therapy, when used in conjunction with CT therapy, improved upper extremity function more than did CT used by itself. However, VR therapy did not enhance ADL performance. This study determined that rigorous and repetitive VR therapy, during the acute stage of stroke rehabilitation, clinically demonstrated an advantage over the use of CT alone. This work is based on the evidence-based literature review completed by Stacie Argade, OTAS, and Megan Cook, OTD, OTR/L, faculty advisor, Northern Virginia Community College. CAP Worksheet adapted from Critical Review Form Quantitative Studies. Copyright 1998 by M. Law, D. Stewart, N. Pollack, L. Letts, J. Bosch, and M. Westmorland, McMaster University. Used with permission. 7