Efficacy of Upper Extremity Robotic Therapy in Subacute Poststroke Hemiplegia: An Exploratory Randomized Trial

Background and Purpose - Our aim was to study the efficacy of robotic therapy as an adjuvant to standard therapy during poststroke rehabilitation. Methods - Prospective, open, blinded end point, randomized, multicenter exploratory clinical trial in Japan of 60 individuals with mild to moderate hemiplegia 4 to 8 weeks post stroke randomized to receive standard therapy plus 40 minutes of either robotic or self-guided therapy for 6 weeks (7 days/week). Upper extremity impairment before and after intervention was measured using the Fugl-Meyer assessment, Wolf Motor Function Test, and Motor Activity Log. Results - Robotic therapy significantly improved Fugl-Meyer assessment flexor synergy (2.1±2.7 versus -0.1±2.4; P<0.01) and proximal upper extremity (4.8±5.0 versus 1.9±5.5; P<0.05) compared with self-guided therapy. No significant changes in Wolf Motor Function Test or Motor Activity Log were observed. Robotic therapy also significantly improved Fugl-Meyer assessment proximal upper extremity among low-functioning patients (baseline Fugl-Meyer assessment score <30) and among patients with Wolf Motor Function Test ≥120 at baseline compared with self-guided therapy (P<0.05 for both). Conclusions - Robotic therapy as an adjuvant to standard rehabilitation may improve upper extremity recovery in moderately impaired poststroke patients. Results of this exploratory study should be interpreted with caution.