OBJECTIVE: The aim of this study was to determine the effectiveness of a novel body-weight-supported (BWS) gait training system with visual feedback, called Copernicus® (Rehalife, Italy). This computerized device provides comfortable, regular and repeatable locomotion in hemiplegic patients. Through visual real-time monitoring of gait parameters, patients are trained to transfer weight loading alternately on both feet. DESIGN: A single-blind, randomized controlled study. A single center used a computer-generated randomization code to allocate treatments. SETTING:Intensive rehabilitation unit (IRU) at the Institute S. Anna (Italy). PARTICIPANTS: 63 first-ever stroke patients (39 men, age: 66.1± 9.6 years; 61.6 % with left-sided lesion) randomly distributed into three demographically/clinically matched groups. TREATMENTS: All groups were treated five times a week for 2 -h sessions for six consecutive weeks. The first group ("control") underwent a conventional physical therapy; the second group performed advanced BWS gait training sessions without visual feedback (Experimental VF- group); whereas the third group used BWS with visual feedback stimulation (Experimental VF+ group). MAIN OUTCOME MEASURES: Absolute changes were recorded using conventional clinical scales and kinematic measurement of static gait balance from baseline to follow-up. RESULTS: Significant interaction Group*Time effects scales (F2,126 = 5.1, p-level = 0.005, η²p = 0.25; F2,126 = 4.7, p-level = 0.007, η²p = 0.19; respectively) were detected in the Functional Independence Measure and Tinetti-Balance scales. Post hoc analysis demonstrated that the recovery of motor functioning was greater for the VF + group with respect to other groups (all p's ≤ 0.001). A similar pattern of findings was also obtained with a stabilometric analysis, demonstrating a better clinical improvement in static balance after VF + treatment. CONCLUSION: The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.
RCT Entities:
OBJECTIVE: The aim of this study was to determine the effectiveness of a novel body-weight-supported (BWS) gait training system with visual feedback, called Copernicus® (Rehalife, Italy). This computerized device provides comfortable, regular and repeatable locomotion in hemiplegic patients. Through visual real-time monitoring of gait parameters, patients are trained to transfer weight loading alternately on both feet. DESIGN: A single-blind, randomized controlled study. A single center used a computer-generated randomization code to allocate treatments. SETTING: Intensive rehabilitation unit (IRU) at the Institute S. Anna (Italy). PARTICIPANTS: 63 first-ever strokepatients (39 men, age: 66.1 ± 9.6 years; 61.6 % with left-sided lesion) randomly distributed into three demographically/clinically matched groups. TREATMENTS: All groups were treated five times a week for 2 -h sessions for six consecutive weeks. The first group ("control") underwent a conventional physical therapy; the second group performed advanced BWS gait training sessions without visual feedback (Experimental VF- group); whereas the third group used BWS with visual feedback stimulation (Experimental VF+ group). MAIN OUTCOME MEASURES: Absolute changes were recorded using conventional clinical scales and kinematic measurement of static gait balance from baseline to follow-up. RESULTS: Significant interaction Group*Time effects scales (F2,126 = 5.1, p-level = 0.005, η²p = 0.25; F2,126 = 4.7, p-level = 0.007, η²p = 0.19; respectively) were detected in the Functional Independence Measure and Tinetti-Balance scales. Post hoc analysis demonstrated that the recovery of motor functioning was greater for the VF + group with respect to other groups (all p's ≤ 0.001). A similar pattern of findings was also obtained with a stabilometric analysis, demonstrating a better clinical improvement in static balance after VF + treatment. CONCLUSION: The proposed advanced rehabilitation system with visual feedback was more effective in improving gait recovery with respect to conventional and high-tech therapies without a sensor feedback.