This process allowed us to assess the arms of the study, and informed consent forms were approved by the effectiveness of blinding the assessor to group allocation. Analysis Given the pilot nature of this study, primarily descriptive statistics Outcome Measures were calculated. The average total therapy time, the average therapy Primary Outcome Measures time per session, and differences 4 weeks after intervention from The coprimary end points of the present study relate to feasibility baseline in clinical outcomes were computed for each group, along and safety.
The Welch t test was used to rule out large differences been formally tested in stroke patients. Therefore, the primary in therapy times. For relevant clinical outcomes, descriptive statistics feasibility outcome was defined as the total time receiving the mean, SD, median, and quartiles were computed for each assess- VRWii intervention. Adjusted treatment analysis was planned a priori assuming The primary safety outcome was defined as the proportion of differences in baseline characteristics as expected in a small sample patients experiencing intervention-related adverse events or any study.
Adjustment treatment effects were obtained from the param- serious adverse event during the study period. A serious adverse eter estimate pertaining to treatment group from multiple linear event was defined as any untoward medical occurrence, whether or regression, for which age, Canadian Neurological Scale, and the not considered to be causally related to the study intervention, that baseline score for the particular outcome being analyzed were resulted in death, life-threatening illness or injury, required inpatient adjusted.
An examination of the residual plots did not suggest hospitalization or prolonged inpatient hospitalization, or resulted in concerns regarding the normality of the errors. A 2-sided P value of persistent disability or incapacity.
All statistical analysis was used to determine fatigability or level of effort required to was performed in the R language for statistical computing R perform tasks at the end of the sessions.
Flow of patients through the trial. A In assessing the success of blinding, we found no evidence total of 88 patients were excluded.
Ten patients refused of failure of concealment at the end of the study. Although 11 patients were randomized to each adverse event during the study period. Table 2 summarizes group, one patient in each arm dropped out after the first the primary outcomes.
There was no difference in the training session, leaving 20 patients randomized 10 to each proportion of patients reporting any symptom during the intervention arm. Baseline characteristics are presented during therapy. The difference in the proportion of patients in Table 1. Relative to patients randomized to the RT groups, ever reporting fatigue was not significant.
The interventions were successfully Canadian Neurological Scale 9. There were no significant imbalances be- The primary end point for time of delivered interventions tween groups with respect to gender, comorbidities, affected showed no difference between groups.
The mean time for the side, handedness, stroke type. Handedness, right 10 91 10 91 Multivariable analyses using linear regression 4 weeks Comorbidities after intervention were performed using baseline measures as Hypertension 5 45 9 82 covariates to evaluate the efficacy of VRWii versus RT.
Similarly, participants Stroke type, hemorrhagic 2 18 2 18 randomized to VRWii achieved a nonsignificant improve- Affected side, right 6 55 6 55 ment in grip strengths when compared with RT after adjust- Baseline functional status at ing for age, baseline grip strength, and stroke severity 1.
No significant differences were observed Chedocke—McMaster, 4. Stroke severity, median The current Modified Rankin scale paradigm of stroke rehabilitation strategies to improve motor 1 1 9 0 0 function is focused on high-intensity, repetitive, and task- 2 3 27 2 18 specific practice.
As reported in recent studies,2,14 the extent to Numbers between brackets represent percentages unless otherwise specified. Secondary End-Points: Clinically The EVREST trial represents the first randomized con- Relevant Outcomes trolled study to systematically test an interactive 3D VR Table 3 summarizes the unadjusted changes in clinical technology using the Wii gaming system as neurorehabilita- outcomes at baseline through 4 weeks after the interventions tion therapy among patients who experienced a first stroke Table 2.
SIS composite includes the following physical domains: strength, hand function, mobility, and activities of daily living. The effect of the VRWii Most of the reported studies focused on lower extremities, gaming technology was compared with RT among patients especially in gait training, including the use of a treadmill.
We found that VRWii Only 3 studies addressed upper limb rehabilitation, and none use was feasible and safe when performed under the prespeci- of them were randomized trials. None of the studies reported fied criteria.
For the efficacy outcomes secondary clinical any significant adverse effects. Moreover, several studies end points , this feasibility study showed a significant im- compared an intervention plus conventional physical therapy provement in motor function WMFT in the unadjusted versus conventional physical therapy alone, which, by neces- Table 3 and adjusted analysis for the VRWii group.
When sity allowed for more rehabilitation time in the experimental reporting outcomes, it is worth knowing whether an observed group.
A more recent systematic review on VR gaming and to 2-second change reported as a the minimal clinically arm motor function found only 2 randomized clinical trials, important difference in previous studies. Finally, the authors of stroke rehabilitation by showing that constraint-induced mo- this systematic review highlighted the potential value and tor therapy can produce a clinically relevant improvement in safety of VR gaming as a tool for stroke rehabilitation but arm function for patients within 6 months of a stroke.
Two recent systematic re- any definitive conclusions about the efficacy of VRWii. However, 3 randomized clinical trials with diverse outcomes measures these results will allow for an informed estimate of the sample memory retraining, walking, gait, and postural stability.
Second, because this study was single- the trial. We also appreciate the use of this treatment and also may have inadvertently dis- support, comments, and suggestions from Drs Vladimir Hachinski closed their treatment allocation to the examiner.
Neverthe- and Sandra Black during conception of the study. No difference was found. Fourth, the VRWii implementation and conduction of the study. Older subjects typically have slower reaction times, with an appar- Sources of Funding ent poorer performance in the RT group.
Finally, the short duration of the intervention 8 HSFO. We are most grateful for the initial funding provided by sessions within 2 weeks may underestimate the effect of South East Toronto Stroke Network, which helped with the early VRWii gaming technology.
In addition, the Wii system only organization of the study design and coordination. Some of these strategies eg, significant The authors declare no financial conflicts of interest.
Repetitive intense training 2. Motor recovery after stroke: a sys- tematic review. Lancet Neurol. Treatment interventions for screen of task-specific activities can facilitate brain plasticity the paretic upper limb of stroke survivors: a critical review.
Neurorehabil mechanisms that engage the mirror neuron system or long- Neural Repair. Effect of constraint-induced movement In summary, the EVREST study constitutes the initial step therapy on upper extremity function 3 to 9 months after stroke: the in the understanding of potential benefits of a novel interac- EXCITE randomized clinical trial.
J Am Med Assoc. The necessity and limitations of evidence-based easily implemented in routine clinical practice. Further, VR practice in stroke rehabilitation. Top Stroke Rehabil. As Salter K. Stroke rehabilitation: an international perspective. Top Stroke such, it provides hope for enhancing motor function and Rehabil. The primary safety outcome was the proportion of patients experiencing intervention-related adverse events during the study period. The mean age range was Two participants dropped out after a training session.
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