Patients were randomly assigned to receive robot-assisted therapy, intensive comparison therapy, or usual care with the use of a permuted-block design that was stratified according to site. Robot-assisted therapy was administered for a maximum of 36 sessions over a period of 12 weeks (up to 14 weeks to allow for missed sessions).
The robotic system consisted of four modules: a shoulder–elbow unit for horizontal movements; an antigravity unit for vertical movements; a wrist unit for flexion–extension, abduction–adduction, and pronation–supination movements; and a grasp-hand unit for closing and opening movements. The 12 weeks of training consisted of four training blocks and were supervised by a therapist. In the first 3-week block, a planar shoulder-and-elbow training robotic device was used. In the second 3-week block, an antigravity shoulder and grasp-hand device was used. In the third 3-week block, the wrist robot was used. In the final block, all three devices were used to integrate proximal (shoulder) to distal (wrist and hand) training (see video).
Modules were used separately and in combination to perform high-intensity, repetitive, task-oriented movements (1024 per session on average), directed by video screens. Training targeted isolated proximal, distal, and integrated movements of the upper limb. The robot provided assistance if patients were unable to initiate or complete a movement independently.
Intensive comparison therapy consisted of a structured protocol using conventional rehabilitative techniques, such as assisted stretching, shoulder-stabilization activities, arm exercises, and functional reaching tasks. This therapy matched robot-assisted therapy in schedule and in the form and intensity of movements.
4 (link),6 (link) The same research personnel delivered both robot-assisted therapy and intensive comparison therapy at each site.
The usual-care group received customary care available to all patients (i.e., medical management, clinic visits as needed, and in some cases rehabilitation services), which was not dictated by the protocol. Patients in the usual-care group were offered their choice of robot-assisted therapy or intensive comparison therapy after their final study visit.
Lo A.C., Guarino P.D., Richards L.G., Haselkorn J.K., Wittenberg G.F., Federman D.G., Ringer R.J., Wagner T.H., Krebs H.I., Volpe B.T., Bever CT J.r., Bravata D.M., Duncan P.W., Corn B.H., Maffucci A.D., Nadeau S.E., Conroy S.S., Powell J.M., Huang G.D, & Peduzzi P. (2010). Robot-Assisted Therapy for Long-Term Upper-Limb Impairment after Stroke. The New England journal of medicine, 362(19), 1772-1783.