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1 CRITICALLY APPRAISED PAPER (CAP) FOCUSED QUESTION: Will use of low-level functional electrical stimulation improve accuracy of active reaching with the upper extremity better than traditional occupational therapy treatment in a client with spasticity and limited range of motion? Ring, H., & Rosenthal, N. (2005). Controlled study of neuroprosthetic functional electrical stimulation in sub-acute post-stroke rehabilitation. Journal of Rehabilitation Medicine, 37(1), CLINICAL BOTTOM LINE: This study aimed to determine whether daily functional electrical stimulation by means of a neuroprosthesis, when added to traditional outpatient therapy, increased recovery for patients in subacute poststroke programs. In particular, the researchers were interested in whether this form of self-treatment at home is a valid method of supplementing standard rehabilitation programs to improve upper limb outcomes. The specific outcomes that were measured included pain, purposeful movement, spasticity, edema, and functional movement. Researchers confirmed that with the use of a neuroprosthesis for home self-treatment, patients with chronic severe hemiparesis showed improvements in upper limb functional tasks. Statistically significant improvements in the outcomes used in this study provide evidence of a treatment intervention that may help improve functional performance of an affected extremity for tasks such as purposeful reaching. Occupational therapists may consider the use of a neuroprosthesis for functional electrical stimulation as a part of a treatment plan when looking to improve the functional use of an affected extremity poststroke. A limitation of this study is that the researchers did not investigate the continued treatment that may be required or the persistence of improvements across time. RESEARCH OBJECTIVE(S) List study objectives. To determine whether the addition of self-treatment at home with a neuroprosthesis would increase recovery in patients (as quantified by active range of motion and functional hand tests) for patients with partial hand motion resulting from chronic severe hemiparesis 1

2 DESIGN TYPE AND LEVEL OF EVIDENCE: Level II: Quasi-experimental design. Patients were stratified according to neurological subgroup type. They were then assigned on an alternating basis to the treated and control groups. SAMPLE SELECTION The researchers did not provide specific information on how participants were recruited and selected for the study. All participants had experienced a cerebral vascular accident (CVA) and were admitted to the day hospital outpatient rehabilitation program at the Loewestein Hospital Rehabilitation Center. Inclusion Criteria Status as a patient 3 6 months after a documented single nonhemorrhagic CVA, moderate to severe hemiparesis (defined as less than full active range of motion in the involved upper limb), cognition adequate to follow multistep commands, and agreement to sign the informed consent for participation in the study Exclusion Criteria Presence of a pacemaker, uncontrolled seizure disorder, joint instability, structural impairment in the involved upper limb, severe neglect, severe aphasia, and unstable medical disorders SAMPLE CHARACTERISTICS N= (Number of participants taking part in the study) 22 #/ (%) Male 16 (72.7%) #/ (%) Female 6 (27.3%) Ethnicity Not specified Disease/disability diagnosis Side of hemiparesis Control group Right: 6 of 11 participants (54.5%) Left: 5 of 11 participants (45.5%) Treated group Right: 4 of 11 participants (36.4%) Left: 7 of 11 participants (63.6%) Subgroups based on level of voluntary motion: Type I (no active voluntary motion at the fingers and wrist): 10 of 22 participants (45.5%) Type II (partial active voluntary range of motion): 12 of 22 participants (54.5%) 2

3 INTERVENTION(S) AND CONTROL GROUPS Add groups if necessary Group 1: Intervention group Brief description of the intervention How many participants in the group? Where did the intervention take place? Who Delivered? How often? For how long? All patients received similar rehabilitation services that were not adjusted or modified on the basis of group assignment. Regular physical and occupational therapy treatment included neuromuscular reeducation with the Bobath techniques and functional treatment to improve performance of activities of daily living (ADLs). This group was fitted with the Handmaster upper limb neuroprosthesis and was instructed on a protocol for daily use of the neuroprosthesis in their home. Participants used two therapeutic stimulation modes: intermittent finger extension, and alternating finger flexion and extension. 11 Use of the Handmaster took place in the participant s home. Standard rehabilitation services took place at the day hospital outpatient rehabilitation program. The use of the Handmaster upper limb neuroprosthesis was selfadministered after initial fitting. The traditional rehabilitation services were carried out by physical and occupational therapists. Participants attended 3 days per week of outpatient rehab services and received at least 3 hr of services per visit. The neuroprosthetic program started with daily system use at 10 min twice a day and progressed up to 50 min three times a day over the first 3 weeks. Patients use of the neuroprosthesis then remained at that level through the remainder of the 6-week study. All patients were reevaluated 6 weeks after beginning the study. Group 2: Control group Brief description of the intervention How many participants in the group? Where did the All patients received similar rehabilitation services that were not adjusted or modified on the basis of group assignment. Regular physical and occupational therapy treatment included neuromuscular reeducation with the Bobath techniques and functional treatment to improve ADL performance. The control group did not seem to receive a home program issued by the researchers that was equal to the total amount of therapy received by the intervention group outside of traditional rehab. 11 Rehabilitation services took place at the day hospital outpatient 3

4 intervention take place? rehabilitation program. Who Delivered? How often? For how long? Traditional rehabilitation services were carried out by physical and occupational therapists. Participants attended 3 days per week of outpatient rehab services and received at least 3 hr of services per visit. All patients were reevaluated 6 weeks after beginning the study. Intervention Biases: Check yes, no, or NR and explain, if needed. Contamination: Co-intervention: Timing: Site: Comment: Participants in the control group were not fitted with the neuroprosthesis, which eliminates the chance of contamination bias. Comment: Although there was no direct evidence of cointervention bias, the researchers acknowledged that participants might have been receiving additional treatments for communication, psychological intervention, and cognitive deficits. These services were provided as needed as a part of their rehabilitation program. Not all participants received these services, and the dosing of such services was not reported. The researchers reported that participants also received varying amounts of therapy and that only the minimum number of hours received was known (at least 3 hr of services each of the 3 days a week they attended). Comment: There was no risk for timing bias as a result of maturation effects. The duration of the study seemed sufficient to measure improvements in the treatment group. Comment: The traditional rehabilitation treatment occurred in the same location for both groups, and all experimental treatment occurred in the participants home. Use of different therapists to provide intervention: Comment: The researchers did not specify whether the same therapists treated the participants during traditional rehabilitation services in the outpatient hospital setting. They also did not state whether more than one person instructed participants on use of the neuroprosthesis, which allowed for bias. The researchers did not provide information on fidelity or training of therapists. 4

5 MEASURES AND OUTCOMES Measure 1: Name/type of Goniometry measure used: What outcome was measured? reliable? valid? When is the measure used? Active forward flexion and abduction range of motion at the shoulder were tested. Active flexion and extension range of motion at the elbow and wrist were both tested. The researchers measured both finger flexion and extension during active movement by recording the distance from the fingertips to the mid-palmar crease. At baseline and at the final evaluation after the 6-week study 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? Measure 4: Name/type of measure used: What outcome was measured? Modified Ashworth Scale Muscle tone and grade spasticity at the shoulder, elbow, wrist, and fingers At baseline and at the final evaluation after the 6-week study Blocks and Box Test Manual dexterity At baseline and at the final evaluation after the 6-week study Jebsen Taylor Hand Function Test Unimanual hand function required for ADLs. The researchers chose to use the subtests for simulated eating, lifting large light objects, and lifting 5

6 reliable? valid? When is the measure used? large heavy objects. These tests were all chosen because they test functional grasp and release in standardized time trials. They also provide quantifiable information regarding ADLs (self-feeding). At baseline and at the final evaluation after the 6-week study Measurement Biases Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. Comment: The assessor was blinded. Recall or memory bias. Check yes, no, or NR, and if yes, explain. Comment: The researchers did not formally address recall or memory bias. A questionnaire or survey was not used, so it is not likely that there was recall or memory bias. Others (list and explain): RESULTS List key findings based on study objectives Include statistical significance where appropriate (p<0.05) Include effect size if reported Findings on reduction of spasticity: The authors performed independent-sample t tests to identify significant differences between the control and treatment groups. A significant difference favoring treatment for greater measured improvement was found in the Type I neuroprosthesis patients (no active voluntary motion at the fingers and wrist) for shoulder and finger spasticity (p =.05 and p =.04, respectively) and in the Type II neuroprosthesis patients (partial active voluntary range of motion) for the shoulder (p =.03), wrist (p =.04), fingers (p =.01), and thumb (p =.04). Findings on increased active motion: There was no statistically significant difference in the active motion in the upper limb for Type I patients, although the neuroprosthesis group achieved a greater level of improvement in the four functional hand tests than the control group. The Type II neuroprosthesis group showed a statistically significant level of shoulder range of motion (p =.003), wrist extension (p =.02), and wrist flexion (p =.04; α =.05). Significant improvement was reported for the treatment group compared with the control group for two Jebsen Taylor tests: light object placement (p =.03) and heavy object 6

7 placement (p =.01). The researchers reported significant improvement in the neuroprosthesis group compared with the control group for the Box and Blocks Test as well (p =.01). The reduction of spasticity in Type I and Type II patients was found to be significant at p =.05 and p =.03, respectively. Was this study adequately powered (large enough to show a difference)? Check yes, no, or NR, and if no, explain. Comment: The researchers acknowledged the potential limitation of having had a small number of participants, and they completed a power analysis using PASS2002 software to determine that values over.75 could be considered statistically significant. Were appropriate analytic methods used? Check yes, no, or NR, and if no, explain. Comment: The authors used independent-sample t tests to find any significant difference between the treatment and control groups. It would have been appropriate to run an analysis of variance on the data in this study, and the researchers should have reported an interaction effect of time and treatment. Were statistics appropriately reported (in written or table format)? Check yes or no, and if no, explain. Comment: A table of statistics was not presented. The researchers should have reported means and standard deviations as well as information on the number of patients who got better, worse, or stayed the same. This information was not clearly reported by the researchers. Was the percent/number of subjects/participants who dropped out of the study reported? Comment: The researchers reported that no participants dropped out of the study. Limitations: The researchers did not investigate the long-term benefits of using a neuroprosthesis treatment system in patients with chronic severe hemiparesis. Measurements were only taken immediately after the participants completed 6 weeks of participation in the study. The dosing of treatment is unknown for both the control and the treatment group. The researchers did not report a system for tracking patients compliance with at-home treatment using the neuroprosthesis. They also did not report the attendance rate for outpatient therapy for either the control or the treatment group. The researchers excluded participants with normal or flaccid muscle tone from the analysis and did not report the number of participants in this group. The control group did not receive a home program to account for the effect of treatment outside of the clinical setting. CONCLUSIONS 7

8 State the authors conclusions related to the research objectives. The authors noted that the results of the study support the hypothesis that a neuroprosthetic system shows potential to improve performance in upper limb functional tasks in patients with chronic severe hemiparesis. Furthermore, they stated that intensive home use of a neuroprosthesis can produce significantly greater improvements in voluntary movement and functional use of the hand (as measured through active range of motion and tests, including the Box and Blocks Test and three subtests of the Jebsen Taylor Hand Function Test). Participants in the treatment groups who initially reported pain (hand or shoulder) reported improvements at the end of the study. Additionally, all participants in the neuroprosthetic groups who initially reported edema reported improvements as well. They also reported greater functional improvement on two Jebsen Taylor tests for the neuroprosthetic group, as observed by improved speed of completion when reaching for items. Last, the Type I neuroprosthetic group of participants showed a statistically significant improvement (greater percentage of change in reduction) in spasticity of the shoulder and fingers. The Type II neuroprosthetic group showed a statistically significant improvement of spasticity in the shoulder, wrist, and fingers. This work is based on the evidence-based literature review completed by Kenneth Reichl, MOT, OTR/L, and Nancy Baker, ScD, MPH, OTR/L, Faculty Advisor, University of Pittsburgh. 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: 8

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