According to statistics from the American Heart Association, more than 6 million Americans have had a stroke, with a prevalence rate of 2.9%.1 Stroke is one of the top 10 causes of disability in the United States,2 with studies reporting that 13% to 30% of people after a stroke are permanently disabled3 and 55% have incomplete recovery.4
Much of the literature on upper extremity recovery for individuals with poststroke hemiparesis has focused on constraint-induced movement therapy (CIMT), which targets those individuals who have active wrist and finger extension.5–9 This criterion excludes many individuals with hemiparesis in whom active extension in the distal upper extremity is impaired. The original CIMT protocol is also very time intensive with 6 hours of one-on-one intervention with a therapist 5 days per week, although it has been studied with some modifications.10,11 Research on CIMT for individuals with hemiparesis who have moderately or severely impaired upper extremity function is lacking, with only case reports exploring CIMT for individuals lacking active extension.12,13
There has been an increasing amount of literature on other interventions for individuals with moderate to severe hemiparesis.14–16 The interventions have included mental practice combined with physical practice, functional electrical stimulation, bilateral arm training, and use of orthotics. Much of this literature is limited to single-case designs without a control or comparison group. A case report by Page et al14 showed that mental practice combined with physical practice (3 days per week for 6 weeks) improved upper extremity Fugl-Meyer and Action Research Arm Test (ARAT) scores in an individual who was 5 months poststroke. Single-case studies published by Dunning et al15 and Page et al,16 using functional electrical stimulation and intensive therapy (3-hour sessions, 5 days per week) for 3 weeks, showed significant improvements in both the Fugl-Meyer and ARAT in individuals with chronic hemiparesis who had no active wrist and finger extension.
Research investigating bilateral arm training with rhythmic auditory cuing (BATRAC) in individuals with chronic hemiparesis has shown improved Fugl-Meyer and Wolf Motor Function Test scores.17 Luft et al18 conducted a randomized controlled study comparing the BATRAC protocol to a dose-matched therapeutic exercise routine. They reported a significantly greater improvement on the upper extremity portion of the Fugl-Meyer with BATRAC compared to the control group. However, of the 9 participants in the BATRAC group, 3 who did not show changes on the functional MRI were removed before statistical analysis, raising questions about the generalizability of the findings.
Electromyography-controlled exoskeletal upper-limb–powered orthoses represent another intervention for individuals with severe chronic hemiparesis. Using this device, Stein et al19 reported significant gains on the upper extremity portion of the Fugl-Meyer and a significant decline in spasticity at the elbow in 8 participants who received a total of 18 hours of training over a 6- to 9-week period. This study had no follow-up or control group. Page et al20 studied the same device in a single-subject case study with a participant with severe hemiplegia. After 8 weeks of three 1-hour sessions per week, this individual made a small 2-point gain in the Fugl-Meyer but had much larger self-reported improvements measured by the Stroke Impact Scale (SIS) and Canadian Occupational Performance Measure.
Beyond those described earlier, another intervention option for individuals with moderate to severe hemiparesis is a dynamic wrist-hand orthosis (WHO). Active finger flexion is required to grasp an object and, when the fingers relax, extension is assisted by the springs located on the dorsal aspect of the orthosis. This allows both release of the grasped object and positioning of the hand to grasp again. This intervention, however, has limited research to support its efficacy. A case report by Butler et al21 utilized the SaeboFlex as a part of an upper extremity training program that also included electric stimulation (6 hours per day, 5 days per week for 2 weeks followed by a 3-month home exercise program (HEP) of 45 minutes per day) with a 44-year-old man who was 6 months after the onset of moderate hemiparesis. A small improvement was found in the Fugl-Meyer upper extremity assessment from an initial baseline measure to 3 months after intervention. However, much of this improvement occurred prior to the intervention. At the 3-month follow-up period, improvement was found in 2 items of the Wolf Motor Function Test. A study performed by the device developers reported improved upper extremity active range of motion, Fugl-Meyer upper extremity score, and the Motor Status Assessment in 13 individuals who used the device as a part of an upper extremity training protocol that also included electric stimulation for 5 consecutive days of 6 hours of training per day.22 There are no published reports comparing intervention with the SaeboFlex to a control group or without concomitant electrical stimulation (Figure 1).
A recent focus of intervention following a stroke has been to increase the number of movement repetitions when practicing a functional task.23 Determining the most optimal and efficient dose of training interventions is one of the most important issues facing physical therapist practice today. Studies on animal stroke models have shown that high numbers of repetitions, in the hundreds, are required to learn an upper extremity task.24,25 Recent observational studies of therapy sessions of patients after stroke showed much lower repetitions, between 13 and 54 for the upper extremity, occurring in the clinical setting.26,27 The number of repetitions or dosage required to improve hand function in individuals with hemiparesis and the best way to accomplish this in the clinic with individuals who have moderate to severe upper extremity paresis is not known. These individuals have great difficulty practicing grasp-and-release activities without assistance. If a device helps individuals practice independently, its use may enhance functional outcomes. Previous studies on the SaeboFlex have not reported the number of repetitions performed.21,22
The purpose of this pilot study was to compare outcomes in individuals with chronic hemiparesis who participated in therapy using a dynamic WHO with outcomes in those who received manual-assisted therapy (MAT). Outcomes related to upper extremity function, grip strength, and quality of life were assessed. The number of repetitions of grasp and release performed during a 1-hour session was also counted to determine the relationship between the number of repetitions of practice and change in hand function, regardless of the treatment group.
Twenty-five individuals were recruited from a sample of convenience with 22 meeting the inclusion criteria. To be included, subjects had to be 6 or more months after the onset of stroke and aged 21 years or older. Strength and range-of-motion criteria were as follows: 15 or more degrees of active shoulder elevation, 15 or more degrees of active elbow flexion, 15 or more degrees of passive wrist extension with relative finger extension, and ability to actively flex digits into 25% of a fist position. These criteria were intended to ensure that participants had the flexibility required to allow their hemiparetic hand to be pulled into an open-handed position, the strength to hold an object, and sufficient movement at the elbow and shoulder to reach toward a target. Participants were excluded if they had the ability to grasp and release a 7.6-cm (3-in) diameter ball, botulinum toxin injections to the paretic upper extremity in the previous 12 weeks, swan neck deformities of the fingers of the hemiparetic upper extremity, history of frequent or current skin breakdown on the hemiparetic upper extremity, severe aphasia, or cognitive impairment determined by a Mini-Mental State Examination score of less than 17/30 (the recommended score when administering the SIS).28 This pilot study was approved by the Maryville University Human Subjects Research Committee. All participants gave their written informed consent to participate in this study.
This study was a pretest, posttest design with block randomization of participants into 1 of 2 intervention groups, therapy with the dynamic WHO group and the MAT group. Group assignment was performed in blocks of 6 by placing 3 pieces of paper for each group in an opaque envelope for the participant to select. All measurements were taken by the same 2 testers, 1 for impairment/function measures and 1 for the quality-of-life measures, before the start of intervention (pretest) and after completing 6 weeks of training (posttest). Testers were blinded to group assignment.
The outcome measures included grip strength, the Box and Blocks (B&B) test, the ARAT, and the SIS. These outcome measures were chosen to cover the body structures and functions, activities, and participation domains of the International Classification of Functioning, Disability and Health model.29
The Stroke Impact Scale version 3.0 was used to measure health-related quality of life. The SIS is a questionnaire measuring the individual's perception in the dimensions of strength, physical function, emotion, communication, memory and thinking, and social role function after stroke. The score for each domain is calculated out of a possible 100 points. The SIS has relatively high reliability with intraclass correlation coefficients (ICCs) of 0.70 to 0.92 in all domains and is sensitive to change over time with a Cronbach α ranging from 0.83 to 0.90.28 The entire instrument was administered, but only the domains of strength, arm use, and perception of their total percent of recovery were analyzed for purposes of the present study.
The ARAT is a well-accepted measure of upper extremity function for individuals after stroke.30,31 This test was performed in the manner described by Lyle,32 wherein participants perform a standardized series of upper extremity tasks with the 19 items grouped into the categories of grasp, grip, pinch, and gross movement. Items were scored on a 4-point scale (0 = unable to perform, 1 = performs partially, 2 = performs abnormally, 3 = performs normally) with a total possible score of 57. The ARAT has been shown to have high interrater reliability with an ICC ranging from 0.97 to 1.0.30–33 The ARAT has also been shown to be a valid measure of upper extremity function as it correlates well with the upper extremity portion of the Motor Activity Score (r = 0.96).30 The B&B test quantifies hand function by counting the number of 2.5-cm (1-in) blocks an individual can transfer over a partition dividing 2 sides of a box in a 1-minute time period. In a population with upper extremity paresis, the B&B test has been found to be reliable (ICC = 0.96).31
Body function and structure
Grip strength was measured by averaging 3 attempts of maximal isometric strength with a grip dynamometer set at the second smallest setting. Participants were seated with their forearm supported on a table, shoulder positioned in neutral, and elbow at 90° flexion. Grip strength in people after chronic stroke has high reliability (ICC > 0.86) and correlates well with tests of upper extremity function.34
For those participants randomly assigned to the WHO group, a SaeboFlex dynamic WHO (Saebo Inc, Charlotte, North Carolina) was fabricated. During the orthosis fitting, one researcher (J.B.), who was trained in the application of this orthosis, adjusted each device to the participant's individual needs and educated the participant (and caregiver) on donning and doffing. Participants in both groups received therapy once per week for 6 weeks with a physical therapist (J.B.) and were instructed to perform an HEP 4 days per week. This training program was designed to be comparable to a typical clinical therapy schedule. The 60-minute therapy session for both groups began with passive stretching and weight-bearing activities with at least 45 minutes focused on reaching toward targets while grasping and releasing balls (Table 1).
During the 45 minutes of grasp-and-release practice component of the therapy session, participants in the WHO group wore the dynamic WHO for most of the therapy session, which focused on grasp and release of a 7.6-cm (3-in) diameter ball. The orthosis was removed near the conclusion of each session, and participants attempted to grasp and release smaller 3.8- to 5.1-cm (1.5- to 2-in diameter) balls. Therapy sessions for the MAT group included the same type of activities as the WHO group except that the dynamic WHO was not used, and manual assistance was given for grasp and release. The approach used during manual assistance for release was to first have the participant try to relax the wrist into flexion, allowing tenodesis to extend the fingers; if that did not get the ball to drop out of their grasp, then the therapist would passively open the grasp, also maintaining an appropriate position for the next grasp. Therapy with both groups incorporated the same equipment during the grasp-and-release practice whenever possible. Only the smaller-sized balls were used, as it was not practical to manually assist participants with grasp and release of the larger balls. The type of exercise completed and the number of repetitions were recorded at each session. From these data, the average number of repetitions over the sessions was calculated. Each participant was instructed in an HEP to be performed 2 times per day on 4 days of the week they were not attending therapy, for the 6 weeks of the study. The HEP included upper extremity weight bearing for both groups, the WHO group then performed grasp-and-release activities with their orthosis (6 exercises with 20 repetitions of each), and the MAT group performed reaching activities, squeezing a ball and best attempts at grasp and release with their hemiparetic arm (6 exercises with 20 repetitions of each). The HEP was designed so the movement required at the elbow and shoulder was the same for both groups. All subjects were given an exercise log to record compliance with the HEP.
Data and Statistical Analysis
The data were explored for normality and baseline differences between the groups. For normally distributed data (grip strength, the self-reported strength on the SIS, and the percent recovery domains of SIS) independent sample t tests were used to assess between-group differences in change scores. Paired sample t tests were performed to assess within-group change from pre- to posttest. For data that were not normally distributed or were nonparametric data (ARAT, B&B test, and arm use domain of SIS), the Mann-Whitney U test and Wilcoxon signed rank test were used, respectively, to assess between-group and within-group differences. In addition, a Pearson product moment correlation was used to explore the relationship between repetitions during practice and the change in hand function. The level of significance was set at P ≤ 0.05. Statistics were calculated using SPSS v. 16.0 (IBM Armonk, New York).
Twenty-two participants met inclusion criteria and were randomized into either a dynamic WHO group (n = 11) or a MAT group (n = 11). Three participants dropped out of the study (1 from the WHO group and 2 from the MAT group) during the intervention period (Figure 2). Of the 19 participants completing the study, 16 attended all 6 sessions while 3 attended only 5 sessions; missed appointments were due to illness or inclement weather. Only 8 participants returned a completed HEP log; therefore, compliance with the HEP and the number of repetitions at home could not be analyzed. Demographic information and characteristics of participants are given in Table 2.
There were no significant between-group differences in baseline (pretest) scores for any of the outcome measures (ARAT, P = 0.22; B&B test, P = 0.14; grip strength, P = 0.21; SIS domains, P values ranged from 0.18 to 0.86).
Comparison of the change scores between the 2 groups identified no significant between-group differences for any of the outcome measures (P values ranging from 0.08 to 0.60; see Table 3).
The WHO group had a significant improvement on the ARAT (P = 0.04) and approached significance on the B&B test (P = 0.07) and grip strength (P = 0.08 with a decline in strength). There was no significant change in any of the SIS domains. The MAT group had a significant improvement on the SIS percent recovery domain (P = 0.03) and approached significance for the ARAT (P = 0.08), and no significant change in grip strength, SIS strength domain, SIS arm use domain, or B&B test (see Table 3).
The relationship between the average number of repetitions during therapy (without regard to intervention group) and the change in outcome measures was moderate for both the ARAT and the B&B test, (r = 0.55, P = 0.02, and r = 0.30, P = 0.10, respectively; Figures 3 and 4).
The purpose of this exploratory study was to compare the outcomes of 2 therapeutic programs of grasp-and-release practice: one using a WHO and the other using manual assistance of a therapist. There was no significant difference between groups for any of the outcome measures used to assess change in the domains of body structure and function (grip strength), activities (the ARAT and the B&B test), or participation (SIS).
Within-group changes showed that the WHO group had a significant improvement in function measured by the ARAT, with a mean change of 2.2 points on this measure. In the MAT group, there was a trend toward improvements in the ARAT with a mean change of 1.4. The minimal clinically important difference (MCID) on the ARAT for persons with poststroke hemiparesis has been reported as 5.7 points28; therefore, the changes observed in this study did not meet this criterion. The MAT group had a significant improvement on the self-report of recovery as indicated by an increase of 15.6 on the percent recovery domain for the SIS. The MCID for the various domains of the SIS is reported to be in a range of 10% to 15% change.28 It is possible that the practice that subjects in the MAT group had with grasp and release without assistance of an external device instilled a perception of greater recovery than that of the WHO group. The amount of improvement they perceived was both statistically and clinically significant.
The relationship between the number of repetitions and change in upper extremity function was moderate for both the ARAT and the B&B test. Given the greater improvement on the ARAT for the WHO group, it is possible that the device allowed more opportunity for successful grasp-and-release practice at home. Because of the poor return rate (<50%) of HEP logs, this concept could not be verified. A method to design a system to accurately track repetitions performed at home should be considered in future studies.
Participants in both groups showed more change on the ARAT than the B&B test. The ARAT may be a more sensitive measure of change. It is possible that floor effects for the B&B test influenced the outcomes with many participants scoring 0 (ie, in the scoring of the B&B test, no points are given for a partial attempt). Following their participation, several participants who were unable to grasp a block prior to the intervention were able to do so after the intervention; however, they were not able to lift it over the divider and release the block to successfully score a point. The ARAT scoring criterion does give 1 point for a partial attempt even if the task is not completed (such as grasping a block but not successfully releasing the block on top of a shelf). This may explain, in part, the greater change measured by the ARAT compared with the B&B test in this study.
This study demonstrated that during a 60-minute therapy session, individuals with chronic moderate hemiparesis were able to accomplish 110 repetitions of grasp and release. This is higher than the numbers that have been reported by Lang et al,27 when observing therapy sessions in multiple clinics. These investigators found that a mean of 32 repetitions of upper extremity functional movements were performed per therapy session.
The MCID on the ARAT is 5.7 points,33 and for the B&B test, it has been reported that a change of 7 blocks is associated with 2 units of difference on the SF-3635 and 5.5 blocks being the MCID.36 Examination of the individual data in this pilot study revealed that 2 participants (1 from the WHO group and 1 from the MAT group) did achieve the MCID on the ARAT (improved 8 and 12 points, respectively) and the same 2 participants also achieved the MCID on the B&B test (improved 7 and 10 blocks, respectively). These 2 participants were among the higher performers at the initial testing session, perhaps suggesting a relationship between baseline values and potential for improvement.
Comparing the results to previous studies on the SaeboFlex is difficult. In addition to using different outcome measures, this study did not include the application of electrical stimulation and had a much lower intensity of 1 hour per week of therapy compared with 6 hours per day, 5 days per week in the protocols by Butler et al21 and Farrell et al.22 Prior investigators were attempting to mimic the intensity used in CIMT protocols, while the present study was intended to provide a frequency of therapy (1 day a week for 6 weeks with an HEP) that is more consistent with the amount of one-on-one treatment time with a therapist in many outpatient rehabilitation settings. While there was no significant difference between the WHO and MAT groups at the beginning of the study, the large standard deviations of scores related to the ARAT and the B&B test in the WHO group may have masked differences, as the mean scores on these measures were slightly higher for the WHO group at the pretest.
Limitations with this study include a small sample size with groups of 9 and 10 participants. While efforts were made to keep the grasp-and-release training similar, differing grasp techniques required the use of different-sized balls during therapy sessions and the HEP. There was also a poor response rate for returning the HEP logs limiting any conclusions in this area. In addition, participants were not categorized by severity of hemiparesis. Stratifying groups using the classifications of moderate and severe impairment on the basis of standardized test scores may have helped understand who benefits from therapy in this population with chronic hemiparesis. Further investigation is warranted with a larger number of participants to investigate issues such as responsiveness of individuals with hemiparesis in the subacute stage, and the influence of the adherence to the HEP. It would also be of value to stratify study participants by severity of hemiparesis to determine whether those with more severe hemiparesis are less likely to improve and possibly establish threshold criteria for individuals most likely to benefit from intervention.
Some individuals in this study had improved upper extremity function that met the MCID for the ARAT and the B&B test. The results add to the evidence supporting that some individuals with chronic hemiparesis who are motivated to participate in therapy and adhere to an HEP may be able to make improvements in their upper extremity function. This is the first study comparing therapy with SaeboFlex plus grasp-and-release training versus grasp-and-release training with manual assistance. While using a dynamic WHO may allow an individual to practice grasp and release more successfully at home, this study found no difference in functional change between these groups.
The findings of this study lend support to the notion that even in the long-term stage of recovery, there is the potential for further functional improvement in some individuals with moderate-to-severe poststroke hemiparesis. This pilot study also adds to the growing literature indicating that higher numbers of repetitions lead to greater functional change in individuals with chronic hemiparesis, as there was a moderate correlation between the number of repetitions and change in the ARAT and the B&B test.
The authors thank Michael T. Cibulka, PT, DPT, MHS, OCS, FAPTA, for his assistance with the statistical analysis of this study.
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Keywords:© 2012 Neurology Section, APTA
arm; function; orthosis; recovery; rehabilitation; repetition; stroke