A Prospective Assessment of an Adjustable, Immediate Fit, Subischial Transfemoral Prosthesis.

Objective: To assess the feasibility of an adjustable, subischial transfemoral prosthesis by comparing self-reported outcome measures regarding socket comfort, fit and utility relative to a persons' conventionally made socket. Assessing limb compressibility was another aim of this study. Design: A single-group pre-post intervention design. Setting: Physical medicine and rehabilitation biomechanics laboratory. Participants: All 18 enrolled participants (N = 18) completed the feasibility trial. There were 16 men and 2 women with an average age of 59.4 (±7) years. Most of the participants (61.1%) had worn a socket for 1 to 10 years before the trial, 22.2% of the participants had worn one for less than a year, and 16.7% of the participants had worn a prosthesis for more than 10 years. Intervention: Participants were fit with the study prosthesis and used it for a 2-week home trial. Main Outcome Measures: A Prosthetic Comfort and Utility Questionnaire was completed on the participant's conventional prosthetic device and the subischial socket system after the trial. Results: The adjustable subischial prostheses were rated superior overall to the participant's conventional sockets (40.9 ± 7.2 vs 32.8 ± 10.8; P=.004). Six of the 10 parameters measured (adjustability, overall fit, prosthesis weight, sitting comfort, standing comfort, and standing stability) were rated higher for the adjustable prostheses compared to the conventional sockets. Compression of the soft tissues of the thigh ranged from 5.6 ± 4.2 cm at the distal end to 7.3 ± 3.6 cm at the proximal site. There were no falls, skin breakdown, or limb ischemia. At the 2-month telephone follow-up, 61% of subjects had transitioned to using the adjustable subischial socket most of the time. Conclusions: The adjustable, immediate fit, subischial prosthesis provided safe, comfortable, and functional ambulation for persons with transfemoral limb loss in this short-term feasibility study. This study supports the consideration of a new paradigm in transfemoral prosthetics-adjustable subischial sockets. These devices should be tested in a larger multi-center study.

An Immediate Fit, Adjustable, Modular Prosthetic System for Addressing World-Wide Limb Loss Disability.

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.

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

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.

Pain Outcomes with an Elliptical Regimen (POWER) Study: Identifying the Proper Dosage of Exercise for Therapeutic Effect in Persons with Chronic Back Pain.

BACKGROUND CONTEXT: Exercise therapy for low back pain has long been prescribed as one of the initial remedies for back pain. Traditional therapy is completed under a therapist's supervision and consists of lumbar stabilization, aerobic exercise and stretching exercises. Recent studies have explored treating back pain with aerobic exercise such as walking which can be done anywhere and without supervision which is lower cost and easily administered. PURPOSE: To assess a therapeutic dosage of aerobic exercise that is associated with pain reduction in persons experiencing low back pain. STUDY DESIGN: Case series. PARTICIPANT DESCRIPTION: Sixteen patients entered the study and twelve patients completed the study (mean ± SD: age 51 ± 11 years; weight 89.2 ± 16 kg). Subjects were included if they were ages 18-65, had chronic back pain lasting for more than 3 months and a score of greater than 30% on the Oswestry Low Back Disability Questionnaire. METHODS: Subjects underwent a six-week exercise program using the elliptical trainer three times each week. Exercise duration was steadily increased each week for the length of the study. The total cumulative amount of work that coincided with significant reductions in chronic low back pain was then identified. RESULTS: At 4 weeks, pain scores were significantly reduced from baseline (3.2 vs 4.7, p<0.0001). This significant pain reduction corresponded to an average of 30.8 Kcal/kg of body mass in cumulative work performed. Pain was significantly reduced by 21% and 32% on the Oswestry Questionnaire and the PROMIS 29 respectively. CONCLUSIONS: These pilot findings suggest that approximately 30.8 kcal/Kg of accumulated physiological work is a therapeutic "dosage" of exercise needed for significant reduction in chronic back pain. Clinicians can begin to use this benchmark for their oversight of rehabilitation programs to determine if an exercise program has been sufficiently intense and long enough in duration for managing their patients with chronic low back pain.

Comparison of Spatiotemporal Gait Parameters Following Operative Treatment of Trimalleolar Ankle Fractures vs Healthy Controls.

BACKGROUND: Controversy continues regarding appropriate indications for posterior malleolus fracture fixation in unstable rotational trimalleolar ankle injuries, with limited data comparing gait in operatively treated trimalleolar ankle fractures vs control populations. The purpose of this study was to evaluate the effect of trimalleolar ankle fracture fixation on gait parameters in the early postoperative period as compared to a healthy control population. METHODS: Adult patients having undergone operative treatment of isolated trimalleolar ankle fractures were eligible for inclusion. A total of 10 patients met the inclusion criteria and participated in the analysis. Patients were evaluated using standard parameters of human gait 6 months after their index procedures, with gait values compared to a population of 17 non-age-matched healthy control subjects in addition to literature values of healthy populations of younger and older subjects. RESULTS: Significant differences were noted between the spatiotemporal gait parameters of healthy control subjects and patients who had undergone operative treatment of trimalleolar ankle fractures. However, within the fracture group itself, no differences were found between patients with or without posterior malleolar fixation for any of the tested gait parameters. When patients were compared to literature values of younger and older healthy control populations, they were found to have gait patterns more similar to older rather than younger individuals. CONCLUSION: Operative fixation of trimalleolar ankle fracture does not restore normal gait function in the early postoperative period. Fixation of the posterior malleolus in particular also does not appear to improve gait characteristics. Patients who undergo surgery for these injuries demonstrate gait patterns similar to those of healthy older adults. LEVEL OF EVIDENCE: Level II, Therapeutic (prospective cohort study).

A Prospective Assessment of an Adjustable, Immediate Fit, Transtibial Prosthesis.

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.