Randomized Trial of a Robotic Assistive Device for the Upper Extremity During Early Inpatient Stroke Rehabilitation

Background. A recent Cochrane Review showed that early robotic training of the upper limb in stroke survivors can be more effective than other interventions when improving activities of daily living involving the arm function is the aim of therapy. Objective. We tested for efficacy of the study a protocol which involved the use of the NeReBot therapy in partial substitution of standard upper limb rehabilitation in post–acute stroke patients. Methods. In this dose-matched, randomized controlled clinical trial, 34 hemiparetic participants with movement against gravity in shoulder, elbow, and wrist muscle groups were enrolled within 15 days of the onset of stroke. All participants received a total daily rehabilitation treatment for 120 minutes, 5 days per week for 5 weeks. The control group received standard therapy for the upper limb. The experimental group received standard therapy (65% of exercise time) associated with robotic training (35% of exercise time). Muscle tone (Modified Ashworth Scale), strength (Medical Research Council), and synergism (Fugl-Meyer motor scores) were measured at impairment level, whereas dexterity (Box and Block Test and Frenchay Arm Test) and activities of daily living (Functional Independence Measure) were measured at activity level. All assessments were performed at baseline, at the end of therapy (time T1), at 3 months (time T2), and at 7 months (time T3) after entry. All between-group analyses were tested using nonparametric test with Bonferroni’s adjustments for multiple testing. Results. No significant between-group differences were found with respect to demographic characteristics, motor, dexterity, and ADLs at baseline, postintervention (T1) and at follow-up (T2 and T3). Conclusions. The robot therapy by NeReBot did not lead to better outcomes compared with conventional inpatient rehabilitation

Residual venous obstruction, alone and in combination with D-dimer, as a risk factor for recurrence after anticoagulation withdrawal following a first idiopathic deep vein thrombosis in the prolong study.

OBJECTIVE: This study aims to assess the predictive value of residual venous obstruction (RVO) for recurrent venous thrombo-embolism (VTE) in a study using D-dimer to predict outcome. DESIGN: This is a multicentre randomised open-label study. METHODS: Patients with a first episode of idiopathic VTE were enrolled on the day of anticoagulation discontinuation when RVO was determined by compression ultrasonography in those with proximal deep vein thrombosis (DVT) of the lower limbs. D-dimer was measured after 1 month. Patients with normal D-dimer did not resume anticoagulation while patients with abnormal D-dimer were randomised to resume anticoagulation or not. The primary outcome measure was recurrent VTE over an 18-month follow-up. RESULTS: A total of 490 DVT patients were analysed (after excluding 19 for different reasons and 118 for isolated pulmonary embolism (PE)). Recurrent DVT occurred in 19% (19/99) of patients with abnormal D-dimer who did not resume anticoagulation and 10% (31/310) in subjects with normal D-dimer (adjusted hazard ratio: 2.1; p = 0.02). Recurrences were similar in subjects either with (11%, 17/151) or without RVO (13%, 32/246). Recurrent DVT rates were also similar for normal D-dimer, with or without RVO, and for abnormal D-dimer, with or without RVO. CONCLUSIONS: Elevated D-dimer at 1 month after anticoagulation withdrawal is a risk factor for recurrence, while RVO at the time of anticoagulation withdrawal is not