Efficacy of Upper Extremity Robotic Therapy in Subacute Poststroke Hemiplegia

Abstract

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. Clinical Trial Registration— URL: http://www.umin.ac.jp/ . Unique identifier: UMIN000001619.

Assessment of the Efficacy of ReoGo-J Robotic Training Against Other Rehabilitation Therapies for Upper-Limb Hemiplegia After Stroke: Protocol for a Randomized Controlled Trial

“…Using the minimal clinically important difference (MCID) as a reference, the mean difference between the patients in the RT and control groups with respect to the FMA upper-limb score is expected to be 4.25 points (30). Given that the subjects in this study will be chronic patients, the deviation is expected to be smaller than that in the pilot study conducted in recovering patients (standard deviation, 8.8) (6), and thus a standard deviation of 6 is expected. Based on a two-sided significance level of 0.05 and a power of 0.9 on Student's t -test, a sample size of 39 per group is needed.…”

“…Hardly any of this research was conducted in East Asia, and thus our study would also be novel in this respect. The robot used in this study, ReoGo-J, is the successor of ReoGo, which was shown to be effective during stroke recovery (6). This study would be the first randomized controlled trial using this new robotic system.…”

“…Considering some loss to follow-up, the sample size was increased from 39 to 40 per group. Additionally, in our similar previous study (6), we recruited 56 case in 6 facilities (about nine case per a facility). Therefore, considering difficulty to recruited case in chronic stage, we judged this study will be feasible to request more than 20 facilities to participate this study.…”

“…Robotic therapy is considered an effective intervention for mild to severe hemiplegic arm (5, 6), and is cost-effective for chronic stroke patients in terms of both manpower and medical costs (7, 8). However, its effects may be limited for some patients.…”

“…However, its effects may be limited for some patients. Some researchers have found that robotic therapy effectively improves arm function as measured by the Fugl-Meyer Assessment (FMA) (9) and Action research arm test (ARAT) (10), but does not improve the use of the affected arm in activities of daily living (ADL) as measured by the Motor activity log (MAL)-14 (11) and by analysis of data from an accelerometer attached to the affected arm (6, 12–14). …”