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Gait rehabilitation: a new biofeedback device for monitoring and enhancing weight-bearing over the affected lower limb
Isakov E
Europa Medicophysica [Mediterranean Journal of Physical and Rehabilitation Medicine] 2007 Mar;43(1):21-26
clinical trial
4/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

AIM: Gait rehabilitation programs often require either partial weight-bearing (PWB) or encourage full weight-bearing (FWB) on the affected limb. Until recently, there was no objective and practical way to measure correct weight-bearing during ambulation. The present study evaluates a new in-shoe device (SmartStep, Andante Medical Devices Ltd) for measuring the amount of weight on the affected limb and for biofeedback gait training. METHODS: The first part of the study aimed to establish the validity of the SmartStep by comparing the results obtained from this device with the results obtained from a force plate. The second part aimed to evaluate the effectiveness of the SmartStep as a biofeedback method in patients who have been referred for FWB gait rehabilitation. Analysis was based on independent samples t-test and Chi squared test for evaluating statistically significant differences between the 2 gait rehabilitation modes. RESULTS: The SmartStep could repeat the same results with 0.53 kg error of mean. Statistically significant correlation was found between results obtained from the SmartStep and from the force plate (R2 = 0.9067 and p = 0.004). The use of the SmartStep auditory biofeedback, significantly (p = 0.00031) improved patients' weight-bearing over the affected limb in the experimental group (7.9 kg +/- 5.28) as compared to the control group (0.7 +/- 2.41 kg). CONCLUSIONS: The SmartStep proved to be very reliable since it generated significant repeatable results which correlated significantly with those obtained from a force plate. Patients recommended for FWB gait can significantly improve body weight loading over the affected limb by the use of the SmartStep auditory biofeedback.

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