Dataset Information

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.

SUBMITTER: McCloskey C

PROVIDER: S-EPMC7771885 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveTo evaluate test-retest reliability and related measurement properties of items developed to assess best, worst, and average prosthetic socket comfort.DesignMethodological research to assess test-retest reliability of 4 individual socket comfort survey items. Socket comfort items were included in a self-report paper survey, which was administered to participants 2 to 3 days apart.SettingGeneral community.ParticipantsA minimum convenience sample of participants (N=63) was targeted for this study; 72 lower limb prosthesis users (>1y postamputation) completed the survey and were included in the final dataset.InterventionsNot applicable.Main outcome measureThe expanded socket comfort score (ESCS) was adapted from the original socket comfort score (SCS). The original SCS is a single-item self-report instrument developed to assess a lower limb prosthesis user's current socket comfort. Three additional items were designed to assess the user's best, worst, and average socket comfort over the previous 7 days.ResultsBest, worst, and average socket comfort items demonstrated better reliability, as indicated by higher intraclass correlation coefficients. As such, these items also exhibited lower measurement error and smaller minimal detectable change values than the item that measured current socket comfort. However, test-retest coefficients for all 4 ESCS items were below the level desired for evaluation of within-individual changes of socket comfort.ConclusionsItems that assess best, worst, and average comfort provide a more stable measurement of socket fit than the existing SCS instrument. Although administration of all 4 ESCS items may provide more comprehensive assessment of a lower limb prosthesis user's socket fit, administrators should expect variations in scores over time owing to the variable nature of the underlying construct over time. Future research should examine whether the ESCS provides an improved overall assessment of socket fit.