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

Abstract

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 two-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 two-week evaluation period.

Main outcome measure: A modified PEQ scale was completed on the participant's conventional prosthetic during the initial visit and the iFIT system after the two weeks.

Results: Twenty-seven persons with lower limb loss were enrolled. Three were lost to follow up leaving twenty-four subjects with completed data. Three subjects 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 [SD= 4.63] vs 23.82 [SD=6.38], p <0.01). Subjects were also found to perceive significantly better temperature control with the iFIT prosthetic system (4.19 [SD= 0.68] vs 2.97 [SD=1.02], p <0.001). Subjects 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.

Keywords: Prosthesis; diabetes; lower limb amputation; transtibial amputation.

Fig 1

Lateral view of the iFIT prosthesis showing locking buckle closure system.

Fig 2

Average difference between iFIT and conventional prosthesis according to PEQ-based questionnaire data based on the 21 participants completing the study who had conventional devices prior to using the adjustable test prosthesis.