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Efficacy of robot-assisted rehabilitation for the functional recovery of the upper limb in post-stroke patients: a randomized controlled study [with consumer summary]
Taveggia G, Borboni A, Salvi L, Mule C, Fogliaresi S, Villafane JH, Casale R
European Journal of Physical and Rehabilitation Medicine 2016 Dec;52(6):767-773
clinical trial
7/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: A prompt and effective physical and rehabilitation medicine approach is essential to obtain recovery of an impaired limb to prevent tendon shortening, spasticity and pain. Robot-assisted virtual reality intervention has been shown to be more effective than conventional interventions and achieved greater improvement in upper limb function. AIM: The aim of this study was to evaluate the effectiveness of robotic-assisted motion and activity in addition to PRM for the rehabilitation of the upper limb in post-stroke inpatients. DESIGN: Randomized controlled trial. SETTING: Departments of Physical and Rehabilitation Medicine from three different hospitals (Sarnico, Brescia; Bergamo; Milan). POPULATION: A total of 54 patients and enrolled 23 men and 31 women with post-stroke hemiparesis, aged 18 to 80 years old, enrolled from July 2014 to February 2015. METHODS: Of the 54 enrolled patients, 57% were female (mean age 71 +/- 12 years), and all had upper limb function deficit post-stroke. The experimental group received a passive mobilization of the upper limb through the robotic device ARMEO Spring and the control group received PRM for 6 consecutive weeks (5 days/week) in addition to traditional PRM. We assessed the impact on functional recovery (Functional Independence Measure (FIM) scale), strength (Motricity Index (MI)), spasticity (Modified Ashworth Scale (MAS)) and pain (Numeric Rating Pain Scale (NRPS)). All patients were evaluated by a blinded observer using the outcomes tests at enrollment (T0), after the treatment (T1) and at follow up 6 weeks later (T2). RESULTS: Both control and experimental groups evidenced an improvement of the outcomes after the treatment (MI, Ashworth and NRPS with p < 0.05). The experimental group showed further improvements after the follow up (all outcomes with p < 0.01). CONCLUSIONS: In the treatment of pain, disability and spasticity in upper limb after stroke, robot-assisted mobilization associated to PRM is as effective as traditional rehabilitation.

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