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Overground walking training with the i-walker, a robotic servo-assistive device, enhances balance in patients with subacute stroke: a randomized controlled trial |
Morone G, Annicchiarico R, Iosa M, Federici A, Paolucci S, Cortes U, Caltagirone C |
Journal of NeuroEngineering & Rehabilitation 2016 May 26;13(47):Epub |
clinical trial |
6/10 [Eligibility criteria: Yes; 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: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
BACKGROUND: Patients affected by mild stroke benefit more from physiological overground walking training than walking-like training performed in place using specific devices. The aim of the study was to evaluate the effects of overground robotic walking training performed with the servo-assistive robotic rollator (i-walker) on walking, balance, gait stability and falls in a community setting in patients with mild subacute stroke. METHODS: Forty-four patients were randomly assigned to two different groups that received the same therapy in two daily 40-min sessions 5 days a week for 4 weeks. Twenty sessions of standard therapy were performed by both groups. In the other 20 sessions the subjects enrolled in the i-walker-group (iWG) performed with the i-walker and the control-group patients (CG) performed the same amount of conventional walking oriented therapy. Clinical and instrumented gait assessments were made pre- and post-treatment. The follow-up observation consisted of recording the number of fallers in the community setting after 6 months. RESULTS: Treatment effectiveness was higher in the iWG group in terms of balance improvement (Tinetti 68.4 +/- 27.6% versus 48.1 +/- 33.9%, p = 0.033) and 10-m and 6-min timed walking tests (significant interaction between group and time F[1,40] = 14.252, p = 0.001; and F[1,40] = 7.883, p = 0.008, respectively). When measured, latero-lateral upper body accelerations were reduced in iWG (F = 4.727, p = 0.036), suggesting increased gait stability, which was supported by a reduced number of falls at home. CONCLUSIONS: A robotic servo-assisted i-walker improved walking performance and balance in patients affected by mild/moderate stroke, leading to increased gait stability and reduced falls in the community. TRIAL REGISTRATION: This study was registered on anzctr.org.au (July 1, 2015; ACTRN12615000681550).
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