PTOTCohortArchives of rehabilitation research and clinical translation2020

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

Chloe McCloskey, Jessica Kenia, Frances Shofer and 2 others

PMID 33381750

WHAT IT FOUND

Participants rated the iFIT adjustable prosthesis significantly better than their conventional device for comfort, stability, and temperature regulation.

No skin breakdown or falls were reported. However, wear time was lower, and the study was short-term with self-selected participants.

Key findings

01The iFIT prosthesis was rated significantly better overall than conventional prostheses (29.18 vs 23.82 on a modified questionnaire), with significant improvements in standing and walking comfort and stability.

02Temperature regulation was the domain with the greatest improvement, with participants rating the iFIT device significantly better for controlling sweating and limb heat.

03No adverse events such as skin breakdown, mechanical failures, or falls were reported during the two-week study period.

STILL TO COME

How it was doneWhat they foundWhat it means for PTsWhat it means for OTs

Read the rest of this summary

You get three full summaries a month, free, and we do not ask for a card. Search, the TL;DRs and your library stay unlimited either way.

Already have one?

What it does not show

The study had a small sample size (24 completers) and a short duration (two weeks), which limits generalizability to long-term use. Participants were volunteers who may have been dissatisfied with their conventional prosthesis, introducing selection bias. The study did not match the prosthetic feet between the iFIT and conventional devices, so differences in comfort or stability could be attributed to the foot component rather than the socket. Wear time was self-reported and varied, with many participants wearing the iFIT device for fewer hours than their conventional prosthesis, which may affect the validity of the comparison. The study was single-center and lacked a control group, relying on pre-post self-comparison.

Declared interests

The authors declared no conflicts of interest. The study was supported by the University of Pennsylvania and the Department of Defense. The iFIT device is manufactured by iFIT Prosthetics, LLC, which provided the devices for the study.

The easy way to misread this

Do not conclude that the iFIT prosthesis is superior for long-term functional use based on this two-week self-reported satisfaction survey. The study lacked a control group, did not match prosthetic feet between conditions, and showed lower wear times for the iFIT device, suggesting that immediate comfort gains may not translate to sustained daily use without further validation.

Read it on PubMed →