Improved Self-Reported Comfort, Stability, and Limb Temperature Regulation With an Immediate Fit, Adjustable Transtibial Prosthesis

OBJECTIVE: The purpose of this investigation was to assess participants’ self-reported satisfaction with an adjustable, immediate fit transtibial prosthetic system as compared to their conventionally fabricated prosthetic device. DESIGN: A prospective study involving a 2-week single-group pre-post intervention design. SETTING: Physical medicine and rehabilitation clinic of a university hospital. PARTICIPANTS: Adults (N=27) with transtibial limb loss. INTERVENTION: Participants were fit with the iFIT prosthetic system and instructed to wear it for a 2-week evaluation period. MAIN OUTCOME MEASURE: A modified Prosthetic Evaluation Questionnaire (PEQ) scale was completed on the participant’s conventional prosthetic during the initial visit and the iFIT system after 2 weeks. RESULTS: Twenty-seven persons with lower limb loss were enrolled. Three were lost to follow-up leaving 24 participants with completed data. Three participants had recent amputations with no conventional device for comparison. The modified PEQ scores were significantly higher for the iFIT prosthetic in comparison to their conventional device (29.18±4.63 vs 23.82±6.38, P<.01). Participants were also found to perceive significantly better temperature control with the iFIT prosthetic system (4.19±0.68 vs 2.97±1.02, P<.001). Participants did not report any skin breakdown, prosthetic issues, or falls. CONCLUSION: This immediate fit, adjustable transtibial prosthesis demonstrated significantly better patient satisfaction and temperature perception compared to conventional devices. These results are consistent with previous findings and further support the efficacy of an immediate fit adjustable transtibial prosthetic system. Longer-term studies in the United States and internationally are underway to assess the durability and efficacy of this new prosthesis in different populations and settings.