RESUMO
Prosthetic services and resources globally are insufficient to meet the needs of individuals with lower limb loss worldwide, particularly in low resource countries. The lack of trained prosthetists, high cost, and inaccessibility of prosthetic services leave many patients in these countries without a prosthesis. To address this problem, an immediate fit, adjustable, modular, prosthetic system was developed. Six individuals in Jamaica with transtibial lower limb loss who were in need of a prosthesis visited a local therapy clinic. They were fit with the prosthetic system by a physical therapist certified and trained in the proper fitting of these devices. All patients were fit on the first visit and walked out with a comfortable prosthesis after some rehabilitation gait training. Five of the patients returned for follow-up and reported that they continued to use these devices for daily wear. No adverse events or socket component failures were reported despite rigorous daily use in a rugged environment. This new prosthetic care delivery model-a modular system distributed to patient locations and fit by trained allied rehabilitation professionals-holds potential for meeting the large demand for lower limb prosthetics in developing countries.
RESUMO
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.
RESUMO
BACKGROUND: There exists a need for an adjustable socket to accommodate residual limb volume and shape changes. Further, limb loss rates globally are rising and there is a large unmet need for affordable and accessible prosthetic systems. OBJECTIVE: To assess the utility of an immediate fit modular prosthetic system (iFIT Prosthetics, LLC). DESIGN: Prospective feasibility study involving a 2-week single-group pre-post intervention study. SETTING: Physical Medicine and Rehabilitation gait laboratory. PARTICIPANTS: Participants were at least 6 months post amputation and walking with a conventional prosthesis. They were free of skin wounds, other neurological disorders, and severe pain conditions. METHODS: Participants were fit with an immediate fit prosthesis and instructed to wear it for a 2-week evaluation period. They were given a progressive wearing schedule and they completed outcome measurements at the 2-week follow-up. MAIN OUTCOME MEASUREMENTS: Self-reported satisfaction, gait biomechanics, and intrasocket peak pressures. RESULTS: Twenty-six participants entered the study, with 22 completing the single group pre-post study. They averaged 50 years (SD ±10.2) of age; four were female. Sixteen were dysvascular and 10 were traumatic in etiology. Significant differences (P = .03) in self-reported satisfaction were found in favor of the iFIT device 29.33 (SD ± 4.51) versus the conventional device 25.52 (SD ± 6.8). No falls or limb ischemia were reported. Gait biomechanics revealed no differences across any temporal characteristics. Intrasocket peak pressures were significantly lower for the iFIT prostheses overall (P = .0014), at the anterior tibia (P = .0002), and the lateral side of the residual limb (P = .013). CONCLUSIONS: The iFIT transtibial prosthetic system appears to be safe in this short-term single-group pre-post study. This study provided preliminary evidence to support the feasibility of the iFIT system. It compared favorably to participants' conventional prostheses across all outcome measures. With its cost, adjustability, and accessibility advantages, this device may prove useful for persons with transtibial amputations. A larger multicenter study is needed to confirm these results. LEVEL OF EVIDENCE: III.
