CRITICALLY APPRAISED PAPER (CAP) Yin, C., Sien, N., Ying, L., Chung, S., & Leng, D. (2014). Virtual reality for upper extremity rehabilitation in early stroke: A pilot randomized controlled trial. Clinical Rehabilitation, 28(11), 1107 1114. http://dx.doi.org/10.1177/0269215514532851 CLINICAL BOTTOM LINE: Virtual reality programs have been used in rehabilitation settings to aid in the therapeutic stroke rehabilitation process. This randomized controlled trial addressed how nonimmersive virtual reality rehabilitation affected the motor performance of the upper extremity in patients with early stroke. The study used 23 participants who were acute stroke recovery patients in an inpatient rehabilitation unit in Singapore. The virtual reality training was a nonimmersive program by Sixense, which consisted of highly repetitive yet functional tasks in an encouraging environment. Participants in the experimental virtual reality group completed 15 sets of 2-min trials during each virtual reality session. This program used a local grocery store as the setting and a task involving placing fruit into a basket. The tasks used extrinsic feedback, and the improvement could be tracked through recorded movement trajectories. The experimental virtual reality group also received conventional therapy, which consisted of physical and occupational therapy. The control group, which received only conventional therapy, had 30-min daily therapy sessions for 9 consecutive days. The experimental group received 30-min virtual reality sessions plus 30- min conventional therapy sessions daily for 9 consecutive days. The virtual reality training program in addition to conventional therapy was not found to be more effective on upper extremity performance than conventional therapy. The difference between the results from nonimmersive virtual reality training and the results from conventional therapy was not statistically significant. The study establishes the practicality of virtual reality training in early stroke rehabilitation in an inpatient stroke rehabilitation setting in Singapore. Virtual reality training on upper extremity performance is an emerging area of practice in occupational therapy that requires additional research and education for practitioners. The limitations of the study affect the generalizability of the results, given the small sample size and heterogeneity of stroke lesions as well as the limited duration of virtual reality training. Additional research is required for more conclusive results on the effectiveness of virtual reality training on upper extremity performance. 1
RESEARCH OBJECTIVE(S) List study objectives. The study objective was to explore how a nonimmersive virtual reality rehabilitation program affected the motor performance of the upper extremity of an individual with acute stroke. DESIGN TYPE AND LEVEL OF EVIDENCE: Randomized controlled trial, Level I SAMPLE SELECTION How were subjects recruited and selected to participate? Please describe. The inpatient rehabilitation unit, where the study was completed, treated acute stroke patients in the initial stages of rehabilitation. Patients at the inpatient rehabilitation unit in Singapore were able to be part of the randomized controlled trial if they met the inclusion criteria and did not meet any of the exclusion criteria. Inclusion Criteria Participants of the study needed to be medically stable to take part in rehabilitation and more than 21 years old. Participants were also required to stand unsupported for 30 s. The researchers used two baseline measures to determine eligibility: Participants needed to score below 62 on the Fugl Meyer Assessment and above 20 on the Mini Mental State Examination. Exclusion Criteria Participants were excluded from the study if they had been diagnosed with epilepsy or photophobia or had experienced known side effects from watching digital media. They were excluded if they were pregnant; had implanted electronic devices, such as pacemakers or defibrillators; or had joint pain that could limit participation in the study. Other exclusion criteria were severe visual deficits and a spasticity score above 2 on the Modified Ashworth Scale in the affected upper extremity. SAMPLE CHARACTERISTICS N= (Number of participants taking part in the study) 23 #/ (%) Male 16/(70%) #/ (%) Female 7/(30%) Ethnicity NR Disease/disability diagnosis Stroke INTERVENTION(S) AND CONTROL GROUPS 2
Add groups if necessary Group 1: Experimental virtual reality with conventional therapy Brief description of the intervention How many participants in the group? Where did the intervention take place? Who Delivered? How often? For how long? The experimental virtual reality training was a nonimmersive program of highly repetitive but functional tasks in a motivating environment. The virtual reality system was a Sixense electromagnetic sensor system that is able to detect movement in three dimensions. It consists of a hand-held remote controller that is detected by a base movement sensor. A laptop computer, customized rehabilitation gaming software, and a 32-in. screen were also part of the training program. The program had customizable difficulty levels and could be calibrated to the participant s active range of motion in the affected upper extremity. Improvement could be tracked through recorded movement trajectories. If a participant was not able to hold the remote controller because of insufficient grip strength, it was strapped to the affected hand with nonallergenic tape and elastic bandage. Also, if the participant was not able to hold his or her arm against gravity, then a table and upper extremity skateboard were available. A local supermarket was chosen as the setting in the virtual reality program because of its familiarity to the participants. Participants completed 15 sets of 2-min trials during each virtual reality session, where they attempted to place fruit from a shelf into a basket as many times as possible. Participants were able to take a rest break between each trial or as needed. Extrinsic motivators, such as cheering and clapping, were used during the sessions. The participants also received conventional therapy, which consisted of physical therapy and occupational therapy, with strength, balance, gait, and functional training, as well as stretching. 11 Inpatient rehabilitation facility in Singapore Two trained and experienced therapists 30 min daily Group 2: Control conventional therapy Brief description of the intervention Nine consecutive weekdays over 2 weeks Conventional therapy consisted of physical therapy and occupational therapy, with strength, balance, gait, and functional training, as well as stretching. 3
How many participants in the group? Where did the intervention take place? Who Delivered? How often? For how long? 12 Inpatient rehabilitation facility in Singapore NR 30 min daily Nine consecutive weekdays over 2 weeks Intervention Biases: Check yes, no, or NR and explain, if needed. Contamination: NR Comment: The study does not state whether any of the conventional therapy group participants might have received the virtual reality therapy. Co-intervention: Comment: Participants in the experimental group also received conventional therapy in addition to the virtual reality program. The authors did not address whether participants were receiving other interventions outside of the study. Timing: Comment: The timing of the intervention might have affected the outcome measures, given that the study was conducted early in the participant s rehabilitation process. Because participants were in the acute stages of rehabilitation, there might have been spontaneous recovery. Site: NR Comment: The article only states that the participants were recruited from an inpatient rehabilitation unit in Singapore; there is no information regarding the space used for either intervention group. Use of different therapists to provide intervention: NR Comment: The virtual reality program had two trained and experienced therapists, yet the study does not report which therapists led the conventional therapy group. 4
MEASURES AND OUTCOMES Measure 1: Name/type of Fugl Meyer Assessment (FMA) What outcome Upper extremity motor impairment, evaluated on a 3-point rating scale NR NR Baseline assessment, postintervention assessment, 1-month postintervention assessment Measure 2: Name/type of What outcome Measure 3: Name/type of What outcome Measure 4: Name/type of What outcome Action Research Arm Test (ARAT) Upper extremity function in grasping, gripping, pinching, and gross movement, evaluated a 4-point rating scale NR NR Baseline assessment, postintervention assessment, 1-month postintervention assessment Motor Activity Log (MAL): Amount scale (AS), How Well scale (HW) The amount of usage of the affected hand in daily tasks, and the quality of hand performance during these tasks NR NR Baseline assessment, postintervention assessment, 1-month postintervention assessment Functional Independence Measure (FIM) General disability NR 5
Measure 5: Name/type of What outcome NR Baseline assessment, postintervention assessment, 1-month postintervention assessment Questionnaire Virtual reality experience NR NR Postintervention assessment for the experimental group Measurement Biases Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. NO Comment: Evaluators were not able to be blinded to the treatment status of the groups, given the limited number of evaluators on staff. Recall or memory bias. Check yes, no, or NR, and if yes, explain. Others (list and explain): Comment: The MAL was self-report, which might have influenced the outcome measure, because participants had to recall information regarding motor activity. RESULTS List key findings based on study objectives Include statistical significance where appropriate (p<0.05) Include effect size if reported Both the virtual reality experimental group and the conventional group improved in all outcome measures, although there was no statistical significance. The FMA results between the experimental and conventional groups were not statistically significant at postintervention (Δ = 2.5, p =.65; d = 0.14) or at 1 month postintervention (Δ = 3.5, p =.97; d = 0.14). 6
The results for the secondary outcome measures were not statistically significant between groups at postintervention: ARAT (Δ = 5.0, p =.65), MAL AS (Δ = 0.23, p =.74), MAL HW (Δ = 0.23, p =.83), FIM (Δ = 1.0, p =.076). The secondary outcome measures were also assessed for between-groups comparisons at 1 month postintervention, with no statistically significant results: ARAT (Δ = 12.0, p =.25), MAL AS (Δ = 0.23, p =.65), MAL HW (Δ = 0.76, p =.097), FIM (Δ = 1.0, p =.82). Was this study adequately powered (large enough to show a difference)? Check yes, no, or NR, and if no, explain. NO Comment: The authors stated that the study was limited by its sample size; therefore, significant changes were not detected. Were appropriate analytic methods used? Check yes, no, or NR, and if no, explain. Comment: Were statistics appropriately reported (in written or table format)? Check yes or no, and if no, explain. Comment: Was the percent/number of subjects/participants who dropped out of the study reported? Limitations: What are the overall study limitations? The study is limited by its small sample size, which contributed to a lack of generalizability of trial results and difficulty detecting significant changes. The heterogeneity of stroke lesions, as well as the limited duration of virtual reality training, were both limitations that affected this randomized controlled trial. Another limitation is the differences in treatment sessions among the conventional therapy patients. There might have been discrepancies in the physical and occupational therapies that patients received, given the vague definition of individual treatment sessions. CONCLUSIONS State the authors conclusions related to the research objectives. 7
The results indicate that both the conventional therapy group and the nonimmersive virtual reality training group helped patients improve hand motor impairment, hand function, and general disability rating on the FIM. There were not statistically significant differences between the experimental and conventional therapy groups when evaluated at the postintervention assessment and at the 1-month postintervention assessment for the FMA, ARAT, MAL AS, MAL HW, and FIM. The results also suggest that virtual reality training along with conventional therapy is a realistic treatment option for patients with early stroke. Future research regarding virtual reality training is recommended that uses a higher intensity treatment and a larger sample size. This work is based on the evidence-based literature review completed by Elizabeth Elling, OTS, and Kelly Erickson, PhD, OTR/L, Assistant Professor, The 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, and M. Westmorland, McMaster University. Used with permission. For personal or educational use only. All other uses require permission from AOTA. Contact: www.copyright.com 8