Crossover study of amputee stair ascent and descent biomechanics using Genium and C-Leg prostheses with comparison to non-amputee control.

This study was a randomized crossover of stair ambulation of Transfemoral Amputees (TFAs) using the Genium and C-Leg prosthetic knees. TFAs typically have difficulty ascending and descending stairs, limiting community mobility. The objective of this study was to determine the relative efficacy of the Genium and C-Leg prostheses for stair ascent and descent, and their absolute efficacy relative to non-amputees. Twenty TFAs, and five non-amputees participated in the study. TFAs were randomized to begin the study with the Genium or C-Leg prosthesis. Informed consent was obtained from all participants prior to data collection and the study was listed on clinicaltrials.gov (#NCT01473662). After fitting, accommodation, and training, participants were asked to demonstrate their preferred gait pattern for stair ascent and descent and a step-over-step pattern if able. TFAs then switched prosthetic legs and repeated fitting, accommodation, training, and testing. An eight camera Vicon optical motion analysis system, and two AMTI force plates were used to track and analyze the participants' gait patterns, knee flexion angles, knee moment normalized by body weight, and swing time. For stair descent, no significant differences were found between prostheses. For stair ascent, Genium use resulted in: increased ability to use a step-over-step gait pattern (p=0.03), increased prosthetic side peak knee flexion (p<0.01), and increased swing duration (p<0.01). Changes in contralateral side outcomes and in knee moment were not significant. Overall the Genium knee decreased deficiency in gait patterns for stair ascent relative to the C-Leg, by enabling gait patterns that more closely resembled non-amputees.

RCT Entities:   Population Interventions Outcomes