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A controlled clinical trial of a clinically-tuned powered ankle prosthesis in people with transtibial amputation

OBJECTIVE: To determine whether there are changes in level walking performance
for people using a powered ankle prosthesis that was tuned by an independent,
manufacturer-certified prosthetist in accordance with device recommendations.
DESIGN: Intervention study with cross-over design.
SETTING: Laboratory.
PARTICIPANTS: Convenience sample of 10 individuals with unilateral, transtibial
amputation, and 10 age- and gender-matched control participants. INTERVENTIONS:
Powered ankle prosthesis (BiOM T2 Ankle System). Main outcome metrics: Metabolic
costs of walking, preferred walking speed. RESULTS: There were no significant
differences in oxygen consumption (2.9% difference; P = 0.606, d = 0.26), cost of
transport (~1% difference; P = 0.652, d = 0.23), or preferred walking speed (~1%
difference; P = 0.147, d = 0.76) when using the powered ankle compared to
unpowered prostheses. Secondary analyses of user characteristics revealed that
participants who were classified as having the highest function (K4 on Medicare's
5-point scale from K0 to K4) were significantly more likely to exhibit energy
cost savings than those classified as having lower function (K3; P = 0.014, d =
2.36). CONCLUSIONS: Participants did not demonstrate significant improvements in
energetics or preferred speed when wearing a clinically tuned powered ankle
prosthesis compared to their non-powered prostheses. Prescribers of powered
devices should understand that not all users will show an immediate reduction in
energy expenditure.

Langue : ANGLAIS

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