Is an Ambulatory Biofeedback Device More Effective than Instructing Partial Weight-Bearing Using a Bathroom Scale? Results of a Randomized Controlled Trial with Healthy Subjects

So far, there have been no high-quality studies examining the efficacy of outpatient biofeedback devices in cases of prescribed partial weight-bearing, such as after surgery on the lower limbs. This study aimed to assess whether a biofeedback device is more effective than using a personal scale. Two groups of healthy individuals wearing an insole orthosis were trained to achieve partial loading in a three-point gait within a target zone of 15-30 kg during overground walking and going up and down stairs. The treatment group (20 women and 22 men) received continuous biofeedback, while the control group (26 women and 16 men) received no information. Findings were compared in a randomized controlled trial. Compliance with partial loading without biofeedback was poor; on level ground and stairs, only one in two steps fell within the target area, and overloading occurred on at least one in three steps. The treatment group reduced the percentage of steps taken in the overload zone to ≤8.4% (<i>p</i> < 0.001 across all three courses) and achieved more than two-thirds of their steps within the target zone (<i>p</i> < 0.001 on level ground, <i>p</i> = 0.008 upstairs, and <i>p</i> = 0.028 downstairs). In contrast, the control group did not demonstrate any significant differences in the target zone (<i>p</i> = 0.571 on level ground, <i>p</i> = 0.332 upstairs, and <i>p</i> = 0.392 downstairs). In terms of maintaining partial load, outpatient biofeedback systems outperform bathroom scales.