Effects of a microprocessor-controlled ankle-foot unit on energy expenditure, quality of life, and postural stability in persons with transtibial amputation: An unblinded, randomized, controlled, cross-over study.

BACKGROUND: Microprocessor-controlled prostheses are designed to improve mobility and quality of life through better balance and energy restoration in persons with transtibial amputation. Quasi-active microprocessor-controlled ankles (MPA) adapt to variable terrain by ankle angle adjustment. OBJECTIVES: To compare energy expenditure, balance, quality of life, and satisfaction of Proprio-foot® (a quasi-active MPA model) with standard prescribed ankle prosthesis (prescribed ankle-foot units [PA]) (standard energy storage and return prosthesis). STUDY DESIGN: Multicenter, unblinded, randomized, controlled, cross-over study. METHODS: Energy expenditure (primary outcome) was assessed by oxygen uptake (VO2) measured at the maximum level reached with the 2 prostheses during treadmill walking at progressively increasing incline and speed. Balance was assessed by stabilometry in different static positions. Quality of life and satisfaction were assessed by "Short Form 36" questionnaire (0-100) and by Evaluation de la Satisfaction envers une Aide Technique (0-5) questionnaires after wearing each of the 2 prostheses for 34 days. RESULTS: Forty-five patients tested the 2 prostheses. No statistical difference in VO2 was observed. Significant improvement of balance was observed both during standing on an incline or decline with MPA and PA (p < 0.01). Short Form 36 questionnaire physical scores and Short Form 36 questionnaire mental scores were 68.5 ± 19.5 vs. 62.1 ± 19.6 (p < 0.01) and 72.0 ± 20.8 vs. 66.2 ± 20.9 (p < 0.01) in MPA and PA, respectively. Evaluation de la Satisfaction envers une Aide Technique score on the device was not statistically significant between the 2 groups (MPA 4.4 ± 0.5 vs. PA 4.3 ± 0.5, p = 0.360). CONCLUSION: Proprio-foot® improved balance, quality of life, and patient satisfaction despite no reduction or increase in energy expenditure in comparison with standard energy storage and return prosthesis.

Development and evaluation of the Walking Estimated-Limitation Calculated by History questionnaire in patients with claudication.

BACKGROUND: The Walking Impairment Questionnaire (WIQ) is used to estimate walking impairment in patients with peripheral artery disease; however, it faces frequent errors when self-completed and is complex to score. We aimed to validate an alternative, easily scored four-item tool, the Walking Estimated-Limitation Calculated by History (WELCH) questionnaire. METHODS: The WIQ and WELCH were prospectively tested in five centers. We studied 434 patients, among which 298 had a treadmill test (3.2 km/h; 10% slope) to determine their maximum walking time (MWT), and 30 were seen twice during the study period. RESULTS: After self-completion, we found at least one error in 177 WIQ (40.8%; 95% confidence interval [CI], 36.3%-45.5%) vs 56 WELCH (12.9%; 95% CI, 10.1%-16.4%) questionnaires (P < .0001). When scoring only questionnaires without missing or duplicate answers, 267 WIQ (61.5%; 95% CI, 56.9%-66.0%) vs 393 WELCH (90.6%; 95% CI, 87.4%-93.0%) questionnaires could be scored (P < .001). The median MWT was 233 seconds (interquartile range, 133-654 seconds) for the 298 patients who had a treadmill test. When the 296 patients who had both questionnaire scores available were studied, no difference was found between the Pearson r coefficient of correlation of the WIQ (r = 0.615) and the WELCH (r = 0.653) with MWT (P = .211). In the 30 patients who completed the WELCH twice, correlation was r = 0.839 (P < .001) between the two scores in 22 nonrevascularized patients, and the area under the receiver-operating characteristic curve was 0.830 ± 0.105 (P < .01) to discriminate the eight revascularized from the 22 nonrevascularized patients. CONCLUSIONS: The WELCH questionnaire is a simple tool to estimate walking limitation in patients with suspected peripheral artery disease. It is easily scored by mental calculation. It may help to standardize the estimation of walking limitation in routine clinical practice.