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1 CRITICALLY APPRAISED PAPER (CAP) Tsang, M. H., Sze, K. H., & Fong, K. N. K. (2008). Occupational therapy treatment with right half-field eye-patching for patients with subacute stroke and unilateral neglect: A randomized controlled trial. Disability and Rehabilitation, 31(8), CLINICAL BOTTOM LINE: Clients with unilateral neglect as a result of a stroke require more time to recover from their stroke, need more assistance with activities of daily living (ADL), and have difficulty executing motor plans. Occupational therapists often see clients with a diagnosis of stroke, and currently there is no reliable intervention that has a lasting, generalizable effect on functioning for clients with unilateral neglect. This Level I randomized controlled trial used blinded evaluators to compare the effectiveness of right half-field blinding during therapy versus conventional therapy treatment in a rehabilitation hospital setting. Findings showed a significant gain on the Behavioral Inattention Test (BIT) with the use of right half-field blinding in patients who had a stroke and unilateral neglect. Blinding, however, did not have an effect on functional abilities as measured by the Functional Independence Measure (FIM). Blinding in a rehabilitation setting was found to be an inexpensive and practical clinical intervention that can easily be used during functional tasks. Limitations of this study include that the BIT and FIM may be too insensitive to measure change, small sample size, intervention may not have been long enough to allow for transfer and generalization, and no follow-up was done to see if the effects of the intervention were maintained. Biases reported included timing, but co-intervention may have contributed to the gains made by the participants. RESEARCH OBJECTIVE(S) List study objectives. Examine the efficacy of conventional occupational therapy treatment with right half-field occlusion in clients who have had a stroke with unilateral neglect. DESIGN TYPE AND LEVEL OF EVIDENCE: Level I: Randomized controlled trial, pretest, posttest design 1

2 SAMPLE SELECTION How were subjects recruited and selected to participate? Please describe. Subjects were recruited by purposive sampling in a rehabilitation hospital setting. Participants from the initial recruitment were assessed using the BIT to confirm unilateral neglect with a score less than 129. Inclusion Criteria Right cerebral vascular disease proven by computer tomography (CT) or magnetic resonance imaging (MRI) Neurological representation compatible with a unilateral (right hemisphere) involvement Evidence on neurological testing of left visual field inattention Right-handed Within 8 weeks of onset of stroke Glasgow coma scale = 15 Exclusion Criteria Severe dysphasia that restricts communication Transient ischemic attack or reversible neurological deficit Significant impairment in visual acuity caused by cataracts, diabetic retinopathy, and glaucoma History of other neurological disease, psychiatric disorder, or alcoholism SAMPLE CHARACTERISTICS N= (Number of participants taking part in the study) 34 #/ (%) Male 21/61.8% #/ (%) Female 13/38.2% Ethnicity NR Disease/disability diagnosis Right cerebral vascular disease with left unilateral neglect INTERVENTION(S) AND CONTROL GROUPS Add groups if necessary Group 1 Brief description of the Group 1 was the control (no eye patch) group. The control group intervention received standard inpatient treatment for the facility, consisting of: 5 hourlong physiotherapy sessions per week 5 hourlong occupational therapy sessions per week Speech therapy and psychological counseling prescribed as needed Skilled nursing care A daily medical round 2

3 How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? Group 2 Brief description of the intervention How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? Occupational therapy sessions specifically involved 30 minutes of training in ADL tasks and 30 minutes of upper extremity remedial tasks using the neurodevelopment approach without eye patching. 17 Inpatient unit of a rehabilitation hospital Occupational therapist 5 60-minute sessions per week 4 weeks Group 2 was the intervention (with eye patch) group. The intervention group received standard inpatient treatment for the facility. This treatment consisted of: 5 hourlong physiotherapy sessions per week 5 hourlong occupational therapy sessions per week Speech therapy and psychological counseling prescribed as needed Skilled nursing care A daily medical round Occupational therapy sessions specifically involved 30 minutes of training in ADL tasks and 30 minutes of upper extremity remedial tasks using the neurodevelopment approach wearing half-field eye patches. 17 Inpatient unit of a rehabilitation hospital Occupational therapist 5 60-minute sessions per week 4 weeks Intervention Biases: Check yes, no, or NR and explain, if needed. Contamination: Comment: This was not reported, but due to the nature of this study, participants in the control group did not inadvertently receive the occlusion intervention. Therefore, contamination is not expected. 3

4 Co-intervention: Timing: Site: NO Comment: Though both the control and intervention groups received the same regime of conventional inpatient care, the results of the study could have been influenced by any of the other therapy interventions they were receiving during the time of the study. Comment: The authors of the study mention this as one of the limitations of the study. The study only lasted 4 weeks, which may not have been long enough for the participants to gain from the intervention. The participants of the study were also in the subacute stage (short time after admission) of stroke recovery, which could have affected how much progress they made in generalizing their skills to functional performance. Comment: All intervention sessions were held at the rehabilitation hospital for both the control and intervention group. Use of different therapists to provide intervention: Comment: The use of different therapists to provide intervention was not mentioned in this study. However, the author stated that all assessors were required to practice the screening assessment for used to identify the presences of unilateral neglect. This process was used to ensure assessors, who were blind to the purpose of the experiment, were consistent when using the assessment. MEASURES AND OUTCOMES Complete for each measure relevant to occupational therapy: Measure 1: Name/type of measure used: Behavioral Inattention Test (BIT), used to measure the presence or absence of unilateral neglect What outcome was Diagnosis of unilateral neglect measured? Is the measure reliable? Is the measure valid? When is the measure used? The authors stated that the test was successful measuring changes in the underlying impairment they were studying (unilateral neglect), but does not generalize to a person s ability to do functional tasks. The BIT was used to classify patients and as a baseline before the study began. The BIT was also used at the end of the 4-week intervention as a post-intervention measure of the intervention s effects. 4

5 Measure 2: Name/type of measure used: What outcome was measured? Is the measure reliable? Is the measure valid? When is the measure used? Functional Independence Measure (FIM), used to measure the functional improvements of the participants Severity of disability by measuring the degree of independence and assistance needed with ADLs NO The authors stated in the discussion section that the FIM may be too insensitive for the type of change they were trying to detect. The FIM was administered pre-intervention to gain a baseline and postintervention to measure the effects of the intervention. Measurement Biases Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. Comment: The authors state that the evaluators at the pretest and posttest were blinded to the purpose of the study. Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. Others (list and explain): Comment: The participants were assessed using the FIM and BIT at pre and post intervention, therefore recall or memory bias may be present. RESULTS List key findings based on study objectives Include statistical significance where appropriate (p < 0.05) Include effect size if reported The participants in the intervention group had a significantly higher BIT gain (mean= 25.06) than the control group (mean = 8.26); p = There was no significant difference in the FIM gain between the intervention group (mean = 16) and the control group (mean = 12.41); p = These findings suggest that the half-field blinding is effective in decreasing unilateral neglect, but that there was no effect on function. Was this study adequately powered (large enough to show a difference)? Check yes, no, or NR, and if no, explain. NO Comment: The authors report that the small sample size may have produced a false-negative (type II error) result on the FIM. 5

6 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 BIT and FIM may be too insensitive to measure change in this study Small sample size Duration of treatment was too short to allow transfer and generalization of skills Limited functional tasks (i.e., utilizing different, meaningful functional activities, particularly with the use of the eye patches) in the treatment sessions Lack of follow-up measurement to determine if the effects of the intervention were maintained. CONCLUSIONS State the authors conclusions related to the research objectives. The study indicates that right half-field eye-patching techniques improved impairment, but does not support improvements in ADL function. Additionally, in shorter lengths of intervention, teaching patients immediate compensatory methods to perform ADLs may lead to short-term task-specific improvement. The effects obtained during the short length of the study and the feasibility in a subacute setting of this study have important implications for occupational therapy interventions for clients in the subacute stage of stroke. This work is based on the evidence-based literature review completed by Taylor Al-Qadhi, OTS, and Kelly Erikson, PhD, OTR/L, Faculty Advisor, College of St. 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: 6

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