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Research Reports |
SJ Page, PhD, FAHA, is Director of Research and Associate Professor, Departments of Rehabilitation Sciences, Physical Medicine and Rehabilitation, and Neurosciences; a member of the Greater Cincinnati/Northern Kentucky Stroke Team; and a Scholar at The Institute for the Study of Health, all at the University of Cincinnati Academic Medical Center, Cincinnati, Ohio. Dr Page also is Director of the Neuromotor Recovery and Rehabilitation Laboratory at Drake Center, Cincinnati, Ohio. Mailing address: 3202 Eden Ave, Suite 310, Cincinnati, OH 45267-0394 (USA)
P Levine, PTA, BA, is Senior Research Assistant, Department of Rehabilitation Sciences, University of Cincinnati Academic Medical Center, and Co-Director of the Neuromotor Recovery and Rehabilitation Laboratory at Drake Center
A Leonard, PhD, is Biostatistician, Institute for the Study of Health, University of Cincinnati College of Medicine
JP Szaflarski, MD, PhD, is Assistant Professor of Neurology, University of Cincinnati College of Medicine
BM Kissela, MD, is a member of the Greater Cincinnati/Northern Kentucky Stroke Team and an Assistant Professor of Neurology, University of Cincinnati College of Medicine
Submitted January 26, 2006;
Accepted November 15, 2007
 | Abstract |
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Subjects: Thirty-five subjects with chronic stroke participated in the study.
Methods: The Action Research Arm Test (ARAT), Fugl-Meyer Assessment of Motor Recovery After Stroke (FM), and Motor Activity Log (MAL) were administered to the subjects.
Results: After intervention, significant differences were observed on the ARAT and MAL Amount of Use and Quality of Movement scales, all in favor of the mCIT group.
Discussion and Conclusion: The data affirm previous findings suggesting that this reimbursable, outpatient protocol increases more affected arm use and function. Magnitude of changes was consistent with those reported in more intense protocols, such as constraint-induced therapy.
| Introduction |
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 TopAbstract Introduction MethodResultsDiscussionConclusionReferences |
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Improvements in more affected arm use and function have been reported after people with stroke participated in constraint-induced therapy (CIT).7–9 Constraint-induced therapy emphasizes massed practice with the more affected upper limb through: (1) restricting patients' less affected upper limbs during 90% of waking hours of a 2-week period and (2) requiring patients to engage in 6-hour activity sessions using their more affected limbs on the 10 weekdays of the same 2-week period. Shaping (see Taub10 for a description) also is applied during the 6-hour therapy sessions, in which the patient is verbally encouraged to perform progressively more difficult components of the movement. Although CIT efficacy was shown in a recently completed trial,11 its clinical feasibility has been questioned.12 Indeed, a recent CIT case study reported that the patient "grew tired of wearing the mitt and had difficulty with full adherence ... ‘cheating’ with the uninvolved hand was a frequent temptation."13(p851) This finding was corroborated by a survey of subjects' and therapists' opinions about CIT,14 in which the majority of the subjects reported that they would not want to participate in CIT and more than 80% of the therapists reported that their facilities could not administer such an intensive protocol. A recently published CIT clinical trial9 also reported that several subjects could not participate because of home duties.
A straightforward, yet efficacious, solution to CIT's limitations has been shorter protocols forcing use of the more affected arm.15,16 The most notable example has been modified constraint-induced therapy (mCIT), which combines structured, half-hour, functional practice sessions occurring 3 days per week with restriction of the less affected arm 5 days per week for 5 hours, both during a 10-week period. Besides its ability to be reimbursed using existing current procedural terminology (CPT) codes, mCIT has been shown to increase more affected arm use and function in case studies17,18 and in randomized controlled pilot studies of subjects with acute stroke (<14 days poststroke),19 subjects with subacute stroke (>3 months and <12 months poststroke),20,21 and subjects with chronic stroke (>12 months poststroke).22 Recent data suggest that cortical reorganizations, brought about by increased more affected arm use during mCIT, are responsible for these motor changes.23
Given promising results in above mCIT work, the needed next step in this line of research was to perform a phase II randomized controlled study with a larger sample; the largest previous mCIT trial22 enrolled 17 subjects. The current randomized controlled study compared mCIT efficacy with that of 2 standards of care for patients who are more than 12 months poststroke: (1) a time-matched exercise regimen for the more affected arm, occurring 3 days per week for 10 weeks, or (2) no therapy, because many patients with stroke at this chronicity and motor level are discharged from formal therapy programs. This population was chosen because the largest amount of data was available concerning mCIT efficacy in subjects who were more than 12 months poststroke, given that minimal spontaneous recovery was expected at more than 12 months poststroke, and because no randomized controlled mCIT study with an appropriate sample size had been performed in this group. Based on previous mCIT study results,22 our primary hypothesis was that subjects in the mCIT group would exhibit significantly greater fine motor function changes, as shown by the ARAT, a measure of distal motor function, than subjects in the other groups. We also hypothesized that subjects in the mCIT group would exhibit markedly larger score increases on the Fugl-Meyer Assessment of Motor Recovery After Stroke (FM) and the Amount of Use (AOU) scale of the Motor Activity Log (MAL) than subjects in the other groups. Given the previously stated need for improved rehabilitation strategies, this study was part of a larger program to develop clinically practical, efficacious strategies to improve motor function after stroke.
| Method |
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TopAbstractIntroductionMethodResultsDiscussionConclusionReferences |
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69 on the Modified Mini Mental Status Examination24; (5) age greater than 18 years and less than 80 years; and (6) more affected arm nonuse, defined as a score of less than 2.5 on the MAL. We also applied the following exclusion criteria: (1) excessive spasticity, defined as a score of 3 on the Modified Ashworth Spasticity Scale25; (2) excessive pain in the more affected arm, as measured by a score of 4 on a 10-point visual analog scale; (3) still enrolled in any form of physical rehabilitation; and (4) currently participating in any experimental rehabilitation or drug studies. Using these inclusion and exclusion criteria, a total of 61 volunteers were screened, with 26 subjects excluded for the following reasons: (1) still enrolled in some form of motor rehabilitation (n=3); (2) insufficient active extension in the more affected wrist or fingers (n=13); (3) inadequate transportation to attend therapy sessions (n=2); (4) excessive spasticity (n=5); and (5) other medical comorbidities (eg, shoulder subluxation, contractures), as determined by the subjects' physiatrists (n=3). Thus, 35 subjects were found to be eligible and agreed to participate. The subjects (22 male, 13 female) had a mean age of 57.9 years (SD=8.4, range=47–76) and a mean time since stroke onset of 39.8 months (range=20–60). Twenty-three subjects had right hemiparesis, and 12 subjects had left hemiparesis. Motor Activity Log AOU scale scores of less than 2.5 and clinical judgments by a therapist team member confirmed that subjects were not regularly using their more affected arms. This judgment was based on the therapist observing the subjects attempt to perform a series of activities of daily living (ADL) as they normally would and on informal discussions with the subjects and their caregivers.
Outcome Measures
Instruments used for this study were applied in previous mCIT studies18–22 and CIT studies9 and are responsive to changes following forced-use programs in chronic stroke.26 The ARAT,27 our primary outcome measure, is a 19-item test divided into 4 categories (grasp, grip, pinch, and gross movement), with each item graded on a 4-point ordinal scale (0=can perform no part of the test, 1=performs test partially, 2=completes test but takes abnormally long time or has great difficulty, and 3=performs test normally) for a total possible score of 57. For this test, subjects were seated in a comfortable chair with a straight back, while the items that they had to grasp were placed on an adjustable table in front of them. Table height was adjusted according to the needs of each subject. The test is hierarchical in that, if the subject is able to perform the most difficult skill in each category, he or she will be able to perform the other items within the category and, thus, need not be tested on those items. The ARAT has high intrarater (r=.99) and retest (r=.98) reliability and validity.27,28
The 66-point, upper-extremity section of the FM,29 which assesses several impairment dimensions using a 3-point ordinal scale (0=cannot perform, 1=can perform partially, and 2=can perform fully). The FM has been shown to have impressive test-retest reliability (total=.98–.99, subtests=.87–1.00),30 interrater reliability, and construct validity.31
The MAL is a semistructured interview measuring how people use their more affected limbs for ADL tasks. On the same day, but in separate rooms, both subjects and caregivers used the MAL's 6-point AOU scale to rate how much the subjects were using their more affected arm and the MAL's 6-point Quality of Movement (QOM) scale to rate how well they were using their more affected arm. Responses to individual items then were averaged based on the number of items to which the subjects responded positively, and average AOU and QOM scores were derived. Previous research32 indicated that the MAL is a valid and reliable scale of arm use and movement quality in real-world settings.
Testing and Intervention
A single-blinded, multiple baseline, randomized, pretest-posttest control group design was applied. After screening and signing consent forms approved by the local institutional review board, the ARAT, FM, and MAL were administered on 2 occasions 1 week apart. This multiple baseline design had 2 purposes. First, it was probable that subjects with chronic stroke would exhibit stable motor deficits. However, given recent findings of improvement years after stroke, multiple administrations of the outcome measures helped us ensure that individuals were exhibiting stable motor deficits. Second, our repeated pretesting design increased the stability of the individual motor estimates, thereby lessening error variance. This diminishes the effect of any preexisting individual differences.
Following the second pretesting session, subjects were randomly assigned to 1 of 3 groups with equal probability of assignment to any of the groups using a computer-generated random numbers table: (1) an mCIT group, (2) a group who received a time-matched rehabilitation program for the more affected arm (TR group), or (3) a no-treatment control group. Therapists hired for this study (n=3) underwent extensive in-service training so that therapy would be consistent. This in-service training included substantial group review of pertinent stroke, CIT, and mCIT literature; hours of cross-validation and videotaping of therapists' responses to various clinical presentations and subject goals; quarterly meetings; and information sessions run by the research team. Therapy sessions, as well as outcome measure testing sessions, were individualized so that no subject interaction was possible. These therapists were randomly assigned to administer the mCIT or TR protocol, with no knowledge of the study hypotheses.
mCIT group.
As in previous studies,17–23 the mCIT intervention, begun 1 week after the second pretesting session, consisted of 2 components. The first component consisted of half-hour, one-on-one sessions of more affected arm therapy occurring 3 days per week during a 10-week period. This component included shaping techniques (see Page and colleagues19–22 for a description) in which operant conditioning was applied in such a way that subjects received positive verbal encouragement to more fully perform selected motor skills with their more affected arm. Shaping was applied with 2 or 3 upper-limb activities (eg, writing, using a fork) chosen by the subjects with help from their therapist. In the second component of the mCIT intervention, during the same 10-week period, subjects' less affected arms were restrained every weekday for 5 hours identified as a time of frequent arm use, as identified by the subjects with assistance from the therapist. Their arms were restrained using a cotton hemi-sling, while their hands were placed in mesh, polystyrene-filled mitts with Velcro straps* around the wrist.
Although no difficulties with adherence to training have been documented in mCIT studies, each subject in the mCIT group and his or her caregiver met prior to the beginning of the first therapy session with the assigned therapist and the principal investigator (SJP), and a behavioral contract was discussed, reviewed, and signed.
TR and control groups.
Subjects who were randomly assigned to the group that received the TR intervention, begun 1 week after the second pretesting session, received half-hour, more affected arm therapy sessions 3 days per week for 10 weeks. Approximately 80% of each session (about 25 minutes) focused on proprioceptive neuromuscular facilitation (PNF) techniques,33 with emphasis on functional tasks whenever possible, as well as stretching of the more affected limb, particularly in the more affected shoulder (ie, extension, adduction, and internal rotation of shoulder with elbow extended and with finger and wrist flexion). The therapists focused, as needed, on compensatory techniques using the less affected side (eg, performing functional tasks with the less affected arm, assisting the more affected arm during reaching tasks) for the remaining 5 minutes. The duration, frequency, and content of therapy provided to subjects in the TR group were consistent with typical therapy provided to patients with stroke at this motor level in our clinics, as indicated by the treating therapists. Moreover, studies have not shown PNF to be more effective than other motor therapies for patients with stroke.34 This regimen, therefore, was chosen.
Subjects assigned to the control group received no therapy during a 10-week period. As noted previously, many subjects more than 3 months poststroke who exhibit distal motor function are discharged from therapy and living in the community, making this a realistic reference condition.
One week after completion of therapy, each subject returned to the laboratory at which pretesting occurred, and the ARAT, FM, and MAL again were administered by the same examiner who administered pretests. The examiner had no knowledge of the subjects' group assignments.
| Results |
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TopAbstractIntroductionMethodResultsDiscussionConclusionReferences |
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Outcomes
After intervention, the mCIT group's MAL scores increased for both the AOU and QOM scales (+2.1 and +1.1, respectively). Small changes in MAL scores were observed for both the AOU and QOM scales in the TR group (+0.4 and +0.3, respectively) and in the control group (–0.5 and –0.3, respectively). Caregiver MAL scores showed similar trends, with increases only in the mCIT condition (AOU scale=+2.3, QOM scale=+1.5) and negligible MAL changes reported by caregivers of subjects in the TR group (AOU scale=+0.6, QOM scale=+0.2) and the control group (AOU scale=–0.3, QOM scale=0.0). Separate repeated-measures ANOVAs were performed for the AOU and QOM scales in which we compared the scores of each scale at each of the 3 test administration points. Analyses revealed significant pretest-posttest changes in MAL scores for the mCIT group on both the AOU scale (F= 49.1, P<.01) and the QOM scale (F=63.1, P<.01). Pretest-posttest AOU and QOM scores did not change significantly for the TR and control groups. Similar trends were observed with caregiver MAL estimates, with significant changes observed in the mCIT group only (AOU scale: F=54.0, P<.01; QOM scale: F=67.5, P<.01) and no changes in caregiver estimates in the TR and control groups.
The mCIT group displayed mean improvements of +7.4 points on the FM and +10.8 points on the ARAT (Table). Subjects in the TR group exhibited less change in FM and ARAT scores (+4.6 and +3.0, respectively), and subjects in the control group exhibited nominal, and sometimes negative, changes in FM and ARAT scores (+2.8 and +0.9, respectively) (Table).
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The 2 primary parallel analyses modeled postintervention FM scores, and alternately ARAT scores, in ANOVA models, which included treatment group membership and each subject's preintervention score on the same test, FM or ARAT, that was being modeled postintervention. Pair-wise differences between groups also were evaluated with post hoc t tests. Because the FM and ARAT both tended to be right skewed, a secondary set of nonparametric analyses was performed. In these analyses, the dependent variable was the preintervention-postintervention change in either FM or ARAT scores, defined as the posttreatment score minus the mean of the 2 preintervention scores. The 3 study groups then were compared on that change value using the Wilcoxon rank sum test. For all tests, a 2-tailed P value of .05 was considered statistically significant.
The Table presents mean preintervention, postintervention, and postintervention FM and ARAT scores for the 3 groups. The preintervention scores listed are means of the 2 preintervention assessments. For the FM, there was no significant treatment effect. Specifically, in the ANOVA using preintervention scores as a control, the postintervention FM scores were not significantly different among groups when considered all together or when compared pair-wise. The Wilcoxon test applied to the change scores similarly revealed no differences among groups. A treatment effect was seen on the ARAT in the ANOVA controlling for preintervention scores (F=13.1; df=2,31; P<.0001), with post hoc pair-wise t tests showing significant differences between the mCIT group, with a mean change score of 10.81, and each of the other 2 groups, with means of 3.00 for the TR group and 0.90 for the control group. The treatment effect compared across all 3 groups also was significant using the Wilcoxon rank sum test (P=.0001).
Subjects' Evaluation of the Treatments
Subjects were informally interviewed by a research team member at the postintervention session, before any outcome testing had occurred. Questions included, "What were your impressions of the therapy program that you participated in?" and "What aspects of the program did you like most/least?" Subjects in the mCIT group expressed a very positive opinion of the mCIT regimen. The most favorable aspects of the regimen included: (1) the ability to perform self-directed, valued activities as part of therapy, (2) the duration of the therapist contact time (this was noted as a positive aspect because it was consistent with the duration of their previous therapy regimens as outpatients and because the duration allowed them to continue with valued ADL tasks), and (3) the ability to markedly improve in motor function without strenuous effort. No adverse events were reported. Subjects in the TR group conveyed positive opinions of the TR protocol duration and appreciated the opportunity to participate in therapy.
| Discussion |
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TopAbstractIntroductionMethodResultsDiscussionConclusionReferences |
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Before intervention, MAL scores were less than 2.0 for all subjects, suggesting that the subjects never or only occasionally used their more affected arms for ADL tasks. Subjects confirmed that they were largely using their less affected limbs for ADL tasks or having someone else perform the ADL tasks for them. Following intervention, subjects in the TR and control groups showed nominal MAL changes and reported use patterns similar to those that they reported before intervention. The subjects in the mCIT group, however, displayed changes greater than +2.0 points on the AOU scale of the MAL, suggesting increased use of the more affected limb for ADL tasks and confirming one of our hypotheses. These MAL changes, particularly in terms of AOU scale scores, were comparable to the results of previous mCIT studies.19–22 Interpersonally, subjects in the mCIT group also reported attempting ADL tasks with the more affected limb that they had not attempted since prior to their strokes. As the intervention period progressed, they realized that they were capable of doing more with their more affected limbs than previously thought and often attempted to perform additional ADL tasks, as reflected by increased MAL AOU scores.
We also hypothesized that subjects would show significant changes on the ARAT and marked changes on the FM. This was because the ARAT exclusively measures distal limb changes, whereas the FM measures changes on the entire arm (including the distal regions). We expected greater changes in the distal regions of the more affected arm because most activities during mCIT emphasize hand and wrist use, and thus greater changes in ARAT scores. Before intervention, subjects' motor deficits were relatively stable, as shown in the Table. Two paired-samples t tests also showed stability of preintervention scores; neither a t test comparing the 2 pretest FM scores nor a t test comparing the 2 pretest ARAT scores showed significant differences. Following intervention, subjects in the mCIT group displayed significant increases in ARAT scores, which was consistent with our primary study hypothesis, and considerable increases in FM scores, which was consistent with our secondary hypothesis. Subjects in the TR group exhibited some changes in scores on both measures, whereas subjects in the control group exhibited nominal changes in scores on both measures. Consistent with our initial hypotheses, individuals in the mCIT group exhibited the greatest gains in FM scores and significantly higher changes in ARAT scores than subjects in the TR and control groups. The greatest changes in the mCIT group were seen on the FM wrist and hand items and on the ARAT grip, grasp, and pinch scales. Only subjects in the mCIT group reported better ability to perform valued ADL tasks that they could not previously perform, including writing and grooming themselves.
The MAL, FM, and ARAT data trends were consistent with those observed in previous mCIT studies with subjects exhibiting stroke.20–22 Our results add to a growing body of literature suggesting that task-specific, repetitive training increases function, even months and years poststroke. A multicenter mCIT trial is now being planned to examine the effect of this intervention with a larger and more diverse group of subjects and to examine the long-term effect of mCIT. Although TR, as used in this study, was a reasonable facsimile of therapy provided in our clinic, many clinics use more task-specific training without shaping as standard of care. Thus, we also will use task-specific training without shaping in a future trial. Collectively, these procedures will overcome limitations of the current study.
Some researchers35 have suggested that a behavioral contract should be administered as part of protocols such mCIT, both so that subjects can fully understand therapy requirements and to better ensure adherence to therapy. However, an additional study limitation is that the gravity of the "contracting" process, although occurring during a regularly scheduled session, was not typical of regular clinical sessions with subjects with stroke. We are skeptical that this process biased the outcomes of the subjects in the mCIT group, as several previous mCIT studies17–19 did not use behavioral contracts but reported similar, positive outcomes. Nonetheless, this possibility cannot be completely ruled out.
Finally, several potential subjects were excluded from this trial due to excessive spasticity or inadequate active movement in the more affected wrists and fingers. Data suggest that mCIT can be effectively combined with botulinum toxin A administration to address the former issue36 and with electromyography-triggered electrical stimulation to address the latter concern.37 Although not a study limitation, future researchers should further examine these treatments as possible gateways to mCIT participation.
It is commonly believed that spontaneous motor recovery is limited to the first 3 to 6 months following stroke.38,39 Additionally, all subjects were reported to have "plateaued," resulting in being discharged from their outpatient therapy regimens. This was substantiated by nonsignificant changes between pretesting sessions 1 and 2. Given these factors, and the very rapid period during which subjects in the mCIT group exhibited motor improvements, motor changes exhibited by individuals who are receiving mCIT are unlikely to be attributable to chance or a "placebo" effect. Consistent with previous CIT and mCIT studies,17–23 each subject was not blinded to his or her individual group assignment. However, subjects were not informed of the group in which the greatest changes were anticipated. This practice further decreased likelihood of a placebo effect.
Although mCIT is reimbursed using existing CPT codes, it is plausible that a therapy session of even shorter duration could produce motor changes. Indeed, some evidence40,41 suggests that as little as 15 minutes of task-specific training is sufficient for cortical reorganization and motor learning to occur. The physical therapy profession should proceed with dose response work to confirm whether there is an optimal duration at which this therapy is maximally efficacious.
| Conclusion |
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| Footnotes |
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This study was approved by the local institutional review board.
This study was supported by a Scientist Development Grant from the American Heart Association to Dr Page.
* Velcro USA inc, PO Box 5218, 406 Brown Ave, Manchester, NH 03103. 
| References |
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