Background and Purpose-Rehabilitation care after stroke is highly variable and increasingly shorter in duration. The effect of therapeutic exercise on impairments and functional limitations after stroke is not clear. The objective of this study was to determine whether a structured, progressive, physiologically based exercise program for subacute stroke produces gains greater than those attributable to spontaneous recovery and usual care. Methods-This randomized, controlled, single-blind clinical trial was conducted in a metropolitan area and 17 participating healthcare institutions. We included persons with stroke who were living in the community. One hundred patients (mean age, 70 years; mean Orpington score, 3.4) consented and were randomized from a screened sample of 582. Ninety-two subjects completed the trial. Intervention was a structured, progressive, physiologically based, therapist-supervised, in-home program of thirty-six 90-minute sessions over 12 weeks targeting flexibility, strength, balance, endurance, and upper-extremity function. Main outcome measures were postintervention strength (ankle and knee isometric peak torque, grip strength), upper-and lower-extremity motor control (Fugl Meyer), balance (Berg and functional reach), endurance (peak aerobic capacity and exercise duration), upper-extremity function (Wolf Motor Function Test), and mobility (timed 10-m walk and 6-minute walk distance). Results-In the intention-to-treat multivariate analysis of variance testing the overall effect, the intervention produced greater gains than usual care (Wilk's ϭ0.64, Pϭ0.0056). Both intervention and usual care groups improved in strength, balance, upper-and lower-extremity motor control, upper-extremity function, and gait velocity. Gains for the intervention group exceeded those in the usual care group in balance, endurance, peak aerobic capacity, and mobility. Upper-extremity gains exceeded those in the usual care group only in patients with higher baseline function. Conclusions-This structured, progressive program of therapeutic exercise in persons who had completed acute rehabilitation services produced gains in endurance, balance, and mobility beyond those attributable to spontaneous recovery and usual care.

Current stroke outcome measures are unable to detect some consequences of stroke that affect patients, families, and providers. The objective of this study was to ensure the content validity of a new stroke outcome measure. This was a qualitative study using individual interviews with patients and focus group interviews with patients, caregivers, and health care professionals. Participants included 30 individuals with mild and moderate stroke, 23 caregivers, and 9 stroke experts. Qualitative analysis of the individual and focus group interviews generated a list of potential items. Consensus panels reviewed the potential items, established domains for the measure, developed item scales, and decided on mechanisms for administration and scoring. Although the participants with stroke appeared highly recovered based on scores from conventional stroke assessments (Barthel Index and NIH Stroke Scale), stroke survivors and their caregivers identified numerous persisting impairments, disabilities, and handicaps. In general, stroke survivors described themselves as only about 50% recovered and reported that they had difficulty in activities in which they were not independent. To fully assess the impact of stroke on patients, we used the results of this qualitative study to develop a new stroke-specific outcome, the Stroke Impact Scale.

Background and Purpose-To be useful for clinical research, an outcome measure must be feasible to administer and have sound psychometric attributes, including reliability, validity, and sensitivity to change. This study characterizes the psychometric properties of the Stroke Impact Scale (SIS) Version 2.0. Methods-Version 2.0 of the SIS is a self-report measure that includes 64 items and assesses 8 domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation). Subjects with mild and moderate strokes completed the SIS at 1 month (nϭ91), at 3 months (nϭ80), and at 6 months after stroke (nϭ69). Twenty-five subjects had a replicate administration of the SIS 1 week after the 3-month or 6-month test. We evaluated internal consistency and test-retest reliability. The validity of the SIS domains was examined by comparing the SIS to existing stroke measures and by comparing differences in SIS scores across Rankin scale levels. The mixed model procedure was used to evaluate responsiveness of the SIS domain scores to change. Results-Each of the 8 domains met or approached the standard of 0.9 ␣-coefficient for comparing the same patients across time. The intraclass correlation coefficients for test-retest reliability of SIS domains ranged from 0.70 to 0.92, except for the emotion domain (0.57). When the domains were compared with established outcome measures, the correlations were moderate to strong (0.44 to 0.84). The participation domain was most strongly associated with SF-36 social role function. SIS domain scores discriminated across 4 Rankin levels. SIS domains are responsive to change due to ongoing recovery. Responsiveness to change is affected by stroke severity and time since stroke. Conclusions-This new, stroke-specific outcome measure is reliable, valid, and sensitive to change. We are optimistic about the utility of measure. More studies are required to evaluate the SIS in larger and more heterogeneous populations and to evaluate the feasibility and validity of proxy responses for the most severely impaired patients. (Stroke. 1999;30:2131-2140.)