Robot-assisted therapy for long-term upper-limb impairment after stroke.
BACKGROUND
Effective rehabilitative therapies are needed for patients with long-term deficits after stroke.


METHODS
In this multicenter, randomized, controlled trial involving 127 patients with moderate-to-severe upper-limb impairment 6 months or more after a stroke, we randomly assigned 49 patients to receive intensive robot-assisted therapy, 50 to receive intensive comparison therapy, and 28 to receive usual care. Therapy consisted of 36 1-hour sessions over a period of 12 weeks. The primary outcome was a change in motor function, as measured on the Fugl-Meyer Assessment of Sensorimotor Recovery after Stroke, at 12 weeks. Secondary outcomes were scores on the Wolf Motor Function Test and the Stroke Impact Scale. Secondary analyses assessed the treatment effect at 36 weeks.


RESULTS
At 12 weeks, the mean Fugl-Meyer score for patients receiving robot-assisted therapy was better than that for patients receiving usual care (difference, 2.17 points; 95% confidence interval [CI], -0.23 to 4.58) and worse than that for patients receiving intensive comparison therapy (difference, -0.14 points; 95% CI, -2.94 to 2.65), but the differences were not significant. The results on the Stroke Impact Scale were significantly better for patients receiving robot-assisted therapy than for those receiving usual care (difference, 7.64 points; 95% CI, 2.03 to 13.24). No other treatment comparisons were significant at 12 weeks. Secondary analyses showed that at 36 weeks, robot-assisted therapy significantly improved the Fugl-Meyer score (difference, 2.88 points; 95% CI, 0.57 to 5.18) and the time on the Wolf Motor Function Test (difference, -8.10 seconds; 95% CI, -13.61 to -2.60) as compared with usual care but not with intensive therapy. No serious adverse events were reported.


CONCLUSIONS
In patients with long-term upper-limb deficits after stroke, robot-assisted therapy did not significantly improve motor function at 12 weeks, as compared with usual care or intensive therapy. In secondary analyses, robot-assisted therapy improved outcomes over 36 weeks as compared with usual care but not with intensive therapy. (ClinicalTrials.gov number, NCT00372411.)
Lo
Albert C
AC
Providence Veterans Affairs Medical Center and Brown University, Providence, RI 02909, USA. albert.lo@va.gov
Guarino
Peter D
PD
Richards
Lorie G
LG
Haselkorn
Jodie K
JK
Wittenberg
George F
GF
Federman
Daniel G
DG
Ringer
Robert J
RJ
Wagner
Todd H
TH
Krebs
Hermano I
HI
Volpe
Bruce T
BT
Bever
Christopher T
CT
Bravata
Dawn M
DM
Duncan
Pamela W
PW
Corn
Barbara H
BH
Maffucci
Alysia D
AD
Nadeau
Stephen E
SE
Conroy
Susan S
SS
Powell
Janet M
JM
Huang
Grant D
GD
Peduzzi
Peter
P
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004185:Disability Evaluation; D005260:Female; D017048:Health Care Costs; D006801:Humans; D016018:Least-Squares Analysis; D008297:Male; D008875:Middle Aged; D009043:Motor Activity; D026741:Physical Therapy Modalities / Q000295:instrumentation; D020127:Recovery of Function; D012371:Robotics / Q000191:economics; D020521:Stroke / Q000503:physiopathology; D000071939:Stroke Rehabilitation; D016896:Treatment Outcome; D034941:Upper Extremity / Q000503:physiopathology*
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