# Adjustable prosthetic sockets for children and adolescents with lower limb loss to accommodate growth

> **NIH NIH R42** · IFIT PROSTHETICS, LLC · 2022 · $880,549

## Abstract

Pediatric limb loss, although relatively infrequent compared to adults, results in substantial hardship for
children and their families. The principal business interest? iFIT Prosthetics, LLC®? successfully developed
and manufactured innovative, fully adjustable, transtibial and transfemoral prosthetic devices, and
demonstrated their safety, comfort, and functionality in adults. Made of injection-molded, advanced-polymer
materials, the iFIT prostheses can be mass-produced at a significant cost advantage relative to conventional
devices. Our overarching goal in this project is to bring such technology to the pediatric market, where
evidence suggests an acute unmet need for comfortable, affordable prosthetic devices that can accommodate
limb growth and prevent skin breakdown as the child develops. Specifically, our Phase I, Specific Aim 1 is to
develop adjustable prosthetic sockets for children with limb loss and limb deficiency. Prototypes using patented
mechanical concepts with pediatric componentry will be tested by five subjects under age 12, at least two with
transfemoral and two with transtibial limb loss. Through a feedback-and-refinement process, we will improve
the prototypes until the optimal design is reached. Evaluation of Phase I success will be based on
objective metrics demonstrating whether: i) the five subjects use the iFIT prostheses and ambulate
comfortably, ii) they ambulate within 10% of their walking speed with their conventional devices, and iii) there
are lower intrasocket pressures with the adjustable prototype devices compared to their conventional sockets.
Phase II, Specific Aim 1 will determine the comfort, ease-of-use, and patient satisfaction with the transtibial
and transfemoral iFIT pediatric prostheses and assess how well growth is accommodated by the adjustable
device. To that end, we will conduct a longitudinal, prospective, 8-week trial of children and adolescents aged 3
to 18 years old with transfemoral (20 subjects) and transtibial (20 subjects) limb loss. Subjects will return at six
and 12 months to assess how well growth has been accommodated. Key outcomes include: i) age-specific,
validated, self-reported measures of patient’s use of and satisfaction with the device as compared to their
conventional prosthesis, ii) a qualitative assessment of prosthetists’ impressions regarding ease-of-fitting, and
iii) objective, quantitative measures of function and use (step monitoring, activity monitoring, gait
biomechanics, and intra-socket pressures). Phase II, Specific Aim 2 will estimate the market potential of iFIT
among children and adolescents, quantify associated prosthetic utilization and costs, and model cost-
effectiveness from payer and societal perspectives of iFIT prostheses relative to conventional devices. With its
adjustable design, the iFIT device holds great promise in addressing the well-documented limitations of current
pediatric prosthetic technology— frequent skin breakdown and limb pain due to ill...

## Key facts

- **NIH application ID:** 10658207
- **Project number:** 4R42HD107747-02
- **Recipient organization:** IFIT PROSTHETICS, LLC
- **Principal Investigator:** TIMOTHY R DILLINGHAM
- **Activity code:** R42 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $880,549
- **Award type:** 4N
- **Project period:** 2022-09-01 → 2024-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10658207

## Citation

> US National Institutes of Health, RePORTER application 10658207, Adjustable prosthetic sockets for children and adolescents with lower limb loss to accommodate growth (4R42HD107747-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10658207. Licensed CC0.

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