Dataset Information

Initial Clinical Evaluation of the Modular Prosthetic Limb.

ABSTRACT: The Modular Prosthetic Limb (MPL) was examined for its feasibility and usability as an advanced, dexterous upper extremity prosthesis with surface electromyography (sEMG) control in with two individuals with below-elbow amputations. Compared to currently marketed prostheses, the MPL has a greater number of sequential and simultaneous degrees of motion, as well as wrist modularity, haptic feedback, and individual digit control. The MPL was successfully fit to a 33-year-old with a trans-radial amputation (TR01) and a 30-year-old with a wrist disarticulation amputation (TR02). To preserve anatomical limb length, we adjusted the powered degrees of freedom of wrist motion between users. Motor training began with practicing sEMG and pattern recognition control within the virtual integration environment (VIE). Prosthetic training sessions then allowed participants to complete a variety of activities of daily living with the MPL. Training and Motion Control Accuracy scores quantified their ability to consistently train and execute unique muscle-to-motion contraction patterns. Each user also completed one prosthetic functional metric-the Southampton Hand Assessment Procedure (SHAP) for TR01 and the Jebsen-Taylor Hand Function Test (JHFT) for TR02. Haptic feedback capabilities were integrated for TR01. TR01 achieved 95% accuracy at 84% of his VIE sessions. He demonstrated improved scores over a year of prosthetic training sessions, ultimately achieving simultaneous control of 13 of the 17 (76%) attempted motions. His performance on the SHAP improved from baseline to final assessment with an increase in number of tasks achieved. TR01 also used vibrotactile sensors to successfully discriminate between hard and soft objects being grasped by the MPL hand. TR02 demonstrated 95% accuracy at 79% of his VIE sessions. He demonstrated improved scores over months of prosthetic training sessions, however there was a significant drop in scores initially following a mid-study pause in testing. He ultimately achieved simultaneous control of all 13 attempted powered motions, and both attempted passive motions. He completed 5 of the 7 (71%) JHFT tasks within the testing time limit. These case studies confirm that it is possible to use non-invasive motor control to increase functional outcomes with individuals with below-elbow amputation and will help to guide future myoelectric prosthetic studies.

SUBMITTER: Perry BN

PROVIDER: S-EPMC5868136 | biostudies-other | 2018

REPOSITORIES: biostudies-other

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Initial Clinical Evaluation of the Modular Prosthetic Limb.

Perry Briana N BN Moran Courtney W CW Armiger Robert S RS Pasquina Paul F PF Vandersea Jamie W JW Tsao Jack W JW

Frontiers in neurology 20180319

The Modular Prosthetic Limb (MPL) was examined for its feasibility and usability as an advanced, dexterous upper extremity prosthesis with surface electromyography (sEMG) control in with two individuals with below-elbow amputations. Compared to currently marketed prostheses, the MPL has a greater number of sequential and simultaneous degrees of motion, as well as wrist modularity, haptic feedback, and individual digit control. The MPL was successfully fit to a 33-year-old with a trans-radial amp ...[more]

PMID: 29615956

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Project description:BackgroundAchieving mobility with a prosthesis is a common post-amputation rehabilitation goal and primary outcome in prosthetic research studies. Patient-reported outcome measures (PROMs) available to measure prosthetic mobility have practical and psychometric limitations that inhibit their use in clinical care and research.ObjectiveTo develop a brief, clinically meaningful, and psychometrically robust PROM to measure prosthetic mobility.DesignA cross-sectional study was conducted to administer previously developed candidate items to a national sample of lower limb prosthesis users. Items were calibrated to an item response theory model and two fixed-length short forms were created. Instruments were assessed for readability, effective range of measurement, agreement with the full item bank, ceiling and floor effects, convergent validity, and known groups validity.SettingParticipants were recruited using flyers posted in hospitals and prosthetics clinics across the United States, magazine advertisements, notices posted to consumer websites, and direct mailings.ParticipantsAdult prosthesis users (N = 1091) with unilateral lower limb amputation due to traumatic or dysvascular causes.InterventionsNot applicable.Main outcome measuresCandidate items (N = 105) were administered along with the Patient Reported Outcome Measurement Information System Brief Profile, Prosthesis Evaluation Questionnaire - Mobility Subscale, and Activities-Specific Balance Confidence Scale, and questions created to characterize respondents.ResultsA bank of 44 calibrated self-report items, termed the Prosthetic Limb Users Survey of Mobility (PLUS-M), was produced. Clinical and statistical criteria were used to select items for 7- and 12-item short forms. PLUS-M instruments had an 8th grade reading level, measured with precision across a wide range of respondents, exhibited little-to-no ceiling or floor effects, correlated expectedly with scores from existing PROMs, and differentiated between groups of respondents expected to have different levels of mobility.ConclusionThe PLUS-M appears to be well suited to measuring prosthetic mobility in people with lower limb amputation. PLUS-M instruments are recommended for use in clinical and research settings.

Project description:Background: Despite advances in prosthetic development and neurorehabilitation, individuals with upper extremity (UE) loss continue to face functional and psychosocial challenges following amputation. Recent advanced myoelectric prostheses offer intuitive control over multiple, simultaneous degrees of motion and promise sensory feedback integration, but require complex training to effectively manipulate. We explored whether a virtual reality simulator could be used to teach dexterous prosthetic control paradigms to individuals with UE loss. Methods: Thirteen active-duty military personnel with UE loss (14 limbs) completed twenty, 30-min passive motor training sessions over 1-2 months. Participants were asked to follow the motions of a virtual avatar using residual and phantom limbs, and electrical activity from the residual limb was recorded using surface electromyography. Eight participants (nine limbs), also completed twenty, 30-min active motor training sessions. Participants controlled a virtual avatar through three motion sets of increasing complexity (Basic, Advanced, and Digit) and were scored on how accurately they performed requested motions. Score trajectory was assessed as a function of time using longitudinal mixed effects linear regression. Results: Mean classification accuracy for passive motor training was 43.8 ± 10.7% (14 limbs, 277 passive sessions). In active motor sessions, >95% classification accuracy (which we used as the threshold for prosthetic acceptance) was achieved by all participants for Basic sets and by 50% of participants in Advanced and Digit sets. Significant improvement in active motor scores over time was observed in Basic and Advanced sets (per additional session: ?-coefficient 0.125, p = 0.022; ?-coefficient 0.45, p = 0.001, respectively), and trended toward significance for Digit sets (?-coefficient 0.594, p = 0.077). Conclusions: These results offer robust evidence that a virtual reality training platform can be used to quickly and efficiently train individuals with UE loss to operate advanced prosthetic control paradigms. Participants can be trained to generate muscle contraction patterns in residual limbs that are interpreted with high accuracy by computer software as distinct active motion commands. These results support the potential viability of advanced myoelectric prostheses relying on pattern recognition feedback or similar controls systems.

Project description:ObjectiveTo assess construct validity of the Prosthetic Limb Users Survey of Mobility (PLUS-M), a self-report mobility measure for people with lower limb amputation (LLA).DesignCross-sectional study.SettingPrivate prosthetic clinics (n=37).ParticipantsCurrent lower limb prosthesis users (N=199; mean age ± SD, 55.4±14.3y; 71.4% men) were assessed before receiving a replacement prosthesis, prosthetic socket, and/or prosthetic knee.InterventionsNot applicable.Main outcome measuresConvergent construct validity was examined using correlations between participants' PLUS-M T-scores and measures of physical function, mobility, and balance, including the Amputee Mobility Predictor (AMP), timed Up and Go (TUG), Patient-Reported Outcomes Measurement Information System-Physical Function (PROMIS-PF), Prosthesis Evaluation Questionnaire-Mobility Subscale (PEQ-MS), and Activities-specific Balance Confidence (ABC) Scale. Known-groups construct validity was evaluated by comparing differences in PLUS-M T-scores among participants grouped by Medicare Functional Classification Level (MFCL).ResultsPLUS-M T-scores demonstrated a moderate positive relationship with AMP scores (ρ=.54, P<.001) and a moderate negative relationship with TUG times (ρ=-.56, P<.001). The PLUS-M also showed a strong positive relationship with PEQ-MS scores (ρ=.78, P<.001), ABC Scale scores (ρ=.81, P<.001), and PROMIS-PF T-scores (ρ=.81, P<.001). Significant differences (P<.05) in PLUS-M T-scores were found among groups of people classified by different MFCLs.ConclusionsStudy results support the validity of the PLUS-M as a self-report measure of prosthetic mobility. Correlations between PLUS-M and measures of physical function, mobility, and balance indicate convergent construct validity. Similarly, significant differences in PLUS-M T-scores across MFCL groups provide evidence of known-groups construct validity. In summary, evidence indicates that PLUS-M has good construct validity among people with LLA.

Project description:PurposeThis study sought to measure and identify factors associated with satisfaction with care among veterans. The metrics were colelcted for those receiving prosthetic limb care at the US Department of Veterans Affairs (VA) and US Department of Defense (DoD) care settings and at community-based care providers.MethodsA longitudinal cohort of veterans with major upper limb amputation receiving any VA care from 2010 to 2015 were interviewed by phone twice, 1 year apart. Care satisfaction was measured by the Orthotics and Prosthetics User's Survey (OPUS) client satisfaction survey (CSS), and prosthesis satisfaction was measured by the OPUS client satisfaction with device (CSD), and the Trinity Amputation and Prosthetic Experience Scale satisfaction scales. The Quality of Care index, developed for this study, assessed care quality. Bivariate analyses and multivariable linear regressions identified factors associated with CSS. Wilcoxon Mann-Whitney rank tests and Fisher exact tests compared CSS and Quality of Care items at follow-up for those with care within and outside of the VA and DoD.ResultsThe study included 808 baseline participants and 585 follow-up participants. Device satisfaction and receipt of amputation care in the prior year were associated with greater satisfaction with care quality. Persons with bilateral amputation were significantly less satisfied with wait times. Veterans who received amputation care in the VA or DoD had better, but not statistically different, mean (SD) CSS scores: 31.6 (22.6) vs 39.4 (16.9), when compared with those who received care outside the VA or DoD. Those with care inside the VA or DoD were also more likely to have a functional assessment in the prior year (33.7% vs 7.1%, P = .06), be contacted by providers (42.7% vs 18.8%, P = .07), and receive amputation care information (41.6% vs 0%, P =.002). No statistically significant differences in CSS, Quality of Care scores, or pain measures were observed between baseline and follow-up. In regression models, those with higher CSD scores and with prior year amputation care had higher satisfaction when compared to those who had not received care.ConclusionsSatisfaction with prosthetic limb care is associated with device satisfaction and receipt of care within the prior year. Veterans receiving amputation care within the VA or DoD received better care quality scores than those receiving prosthetic care outside of the VA or DoD. Satisfaction with care and quality of care were stable over the 12 months of this study. Findings from this study can serve as benchmarks for future work on care satisfaction and quality of amputation rehabilitative care.

Project description:BackgroundLower limb amputation contributes to structural and functional brain alterations, adversely affecting gait, balance, and overall quality of life. Therefore, selecting an appropriate prosthetic ankle is critical in enhancing the well-being of these individuals. Despite the availability of various prostheses, their impact on brain neuroplasticity remains poorly understood.ObjectivesThe primary objective is to examine differences in the degree of brain neuroplasticity using magnetic resonance imaging (MRI) between individuals wearing a new passive ankle prosthesis with an articulated ankle joint and a standard passive prosthesis, and to examine changes in brain neuroplasticity within these two prosthetic groups. The second objective is to investigate the influence of prosthetic type on walking performance and quality of life. The final objective is to determine whether the type of prosthesis induces differences in the walking movement pattern.MethodsParticipants with a unilateral transtibial amputation will follow a 24-week protocol. Prior to rehabilitation, baseline MRI scans will be performed, followed by allocation to the intervention arms and commencement of rehabilitation. After 12 weeks, baseline functional performance tests and a quality of life questionnaire will be administered. At the end of the 24-week period, participants will undergo the same MRI scans, functional performance tests and questionnaire to evaluate any changes. A control group of able-bodied individuals will be included for comparative analysis.ConclusionThis study aims to unravel the differences in brain neuroplasticity and prosthesis type in patients with a unilateral transtibial amputation and provide insights into the therapeutic benefits of prosthetic devices. The findings could validate the therapeutic benefits of more advanced lower limb prostheses, potentially leading to a societal impact ultimately improving the quality of life for individuals with lower limb amputation.Trial registrationNCT05818410 (Clinicaltrials.gov).

Dataset Information

Initial Clinical Evaluation of the Modular Prosthetic Limb.

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Initial Clinical Evaluation of the Modular Prosthetic Limb.

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