Dataset Information

Effect of temperature-control liner materials on long-term outcomes of lower limb prosthesis use: a randomized controlled trial protocol.

ABSTRACT: BACKGROUND:In people living with limb loss, addressing the resulting functional deficit with prostheses increases the risk for secondary conditions such as pressure sores, impaired blood perfusion, and injuries from accidental falls. Any of those occurrences can render the prosthesis temporarily useless, making it challenging for users to engage in many activities of daily life, including work, exercise, and social participation. Many of the described issues originate at the interface between residual limb and prosthetic socket, where the objectives of sufficient weight distribution and suspension are conflicting with the necessity to facilitate heat exchange and limit contact pressure and friction. Recently, prosthesis liners that contain phase-change material have become commercially available, holding the promise that the micro climate at the interface between the residual limb skin and the prosthetic socket can be regulated to reduce the users' tendency to sweat. Preliminary studies on these liners indicate that the socket temperatures inside the socket stayed lower and rose slower than in conventional liners. However, the clinical relevance of those findings remains unclear. The purpose of this study is to investigate whether longer (6+ months) periods of use of phase-change material based temperature-control liners have clinically meaningful effects. METHODS:The protocol is a double-blind longitudinal cross-over research design. A sample of trans-tibial prosthesis users are wearing their regular gel or silicone liners for six months and phase-change material liners for another six months in a randomized sequence. Their prostheses is equipped with activity monitors to detect days when they could not wear their prosthesis. In six-week intervals, individuals' activity, physical performance, and overall prosthesis assessment is recorded using standardized methods. DISCUSSION:Expected results will inform prescription and reimbursement practice of phase-change material-based prosthesis liners and will help improve and economize prosthetic fitting for people with limb loss. The design and duration of the protocol, including randomization, blinding, and within-subject comparison, will generate scientific evidence of a comparably high level. Inclusion of a comparably large sample and different climates, e.g. across all four seasons, will make findings applicable to a large number of prosthesis users. TRIAL REGISTRATION:Clinicaltrials.gov, NCT03428815. Registered on 12 February 2018.

SUBMITTER: Fiedler G

PROVIDER: S-EPMC6954540 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Effect of temperature-control liner materials on long-term outcomes of lower limb prosthesis use: a randomized controlled trial protocol.

Fiedler Goeran G Singh Anita A Zhang Xueyi X

Trials 20200110 1

<h4>Background</h4>In people living with limb loss, addressing the resulting functional deficit with prostheses increases the risk for secondary conditions such as pressure sores, impaired blood perfusion, and injuries from accidental falls. Any of those occurrences can render the prosthesis temporarily useless, making it challenging for users to engage in many activities of daily life, including work, exercise, and social participation. Many of the described issues originate at the interface be ...[more]

PMID: 31924257

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Project description:IntroductionTuning of lower-limb (LL) robotic prosthesis control is necessary to provide personalised assistance to each human wearer during walking. Prostheses wearers' adaptation processes are subjective and the efficiency largely depends on one's mental processes. Therefore, beyond physical motor performance, prosthesis personalisation should consider the wearer's preference and cognitive performance during walking. As a first step, it is necessary to examine the current measures of cognitive performance when a wearer walks with an LL prosthesis, identify the gaps and methodological considerations, and explore additional measures in a walking setting. In this protocol, we outlined a scoping review that will systematically summarise and evaluate the measures of cognitive performance during walking with and without LL prosthesis.Methods and analysisThe review process will be guided and documented by CADIMA, an open-access online data management portal for evidence synthesis. Keyword searches will be conducted in seven databases (Web of Science, MEDLINE, BIOSIS, SciELO Citation Index, ProQuest, CINAHL and PsycINFO) up to 2020 supplemented with grey literature searches. Retrieved records will be screened by at least two independent reviewers on the title-and-abstract level and then the full-text level. Selected studies will be evaluated for reporting bias. Data on sample characteristics, type of cognitive function, characteristics of cognitive measures, task prioritisation, experimental design and walking setting will be extracted.Ethics and disseminationThis scoping review will evaluate the measures used in previously published studies thus does not require ethical approval. The results will contribute to the advancement of prosthesis tuning processes by reviewing the application status of cognitive measures during walking with and without prosthesis and laying the foundation for developing needed measures for cognitive assessment during walking. The results will be disseminated through conferences and journals.

Project description:ObjectiveTo evaluate the content, construct, and discriminant validity of the Narrowing Beam Walking Test (NBWT), a performance-based balance test for lower limb prosthesis users.DesignCross-sectional study.SettingResearch laboratory and prosthetics clinic.ParticipantsUnilateral transtibial and transfemoral prosthesis users (N=40).InterventionsNot applicable.Main outcome measuresContent validity was examined by quantifying the percentage of participants receiving maximum or minimum scores (ie, ceiling and floor effects). Convergent construct validity was examined using correlations between participants' NBWT scores and scores or times on existing clinical balance tests regularly administered to lower limb prosthesis users. Known-groups construct validity was examined by comparing NBWT scores between groups of participants with different fall histories, amputation levels, amputation etiologies, and functional levels. Discriminant validity was evaluated by analyzing the area under each test's receiver operating characteristic (ROC) curve.ResultsNo minimum or maximum scores were recorded on the NBWT. NBWT scores demonstrated strong correlations (ρ=.70‒.85) with scores/times on performance-based balance tests (timed Up and Go test, Four Square Step Test, and Berg Balance Scale) and a moderate correlation (ρ=.49) with the self-report Activities-specific Balance Confidence scale. NBWT performance was significantly lower among participants with a history of falls (P=.003), transfemoral amputation (P=.011), and a lower mobility level (P<.001). The NBWT also had the largest area under the ROC curve (.81) and was the only test to exhibit an area that was statistically significantly >.50 (ie, chance).ConclusionsThe results provide strong evidence of content, construct, and discriminant validity for the NBWT as a performance-based test of balance ability. The evidence supports its use to assess balance impairments and fall risk in unilateral transtibial and transfemoral prosthesis users.

Project description:Objective.Electrical stimulation can induce sensation in the phantom limb of individuals with amputation. It is difficult to generalize existing findings as there are many approaches to delivering stimulation and to assessing the characteristics and benefits of sensation. Therefore, the goal of this systematic review was to explore the stimulation parameters that effectively elicited referred sensation, the qualities of elicited sensation, and how the utility of referred sensation was assessed.Approach.We searched PubMed, Web of Science, and Engineering Village through January of 2022 to identify relevant papers. We included papers which electrically induced referred sensation in individuals with limb loss and excluded papers that did not contain stimulation parameters or outcome measures pertaining to stimulation. We extracted information on participant demographics, stimulation approaches, and participant outcomes.Main results.After applying exclusion criteria, 49 papers were included covering nine stimulation methods. Amplitude was the most commonly adjusted parameter (n= 25), followed by frequency (n= 22), and pulse width (n= 15). Of the 63 reports of sensation quality, most reported feelings of pressure (n= 52), paresthesia (n= 48), or vibration (n= 40) while less than half (n= 29) reported a sense of position or movement. Most papers evaluated the functional benefits of sensation (n= 33) using force matching or object identification tasks, while fewer papers quantified subjective measures (n= 16) such as pain or embodiment. Only 15 studies (36%) observed percept intensity, quality, or location over multiple sessions.Significance.Most studies that measured functional performance demonstrated some benefit to providing participants with sensory feedback. However, few studies could experimentally manipulate sensation location or quality. Direct comparisons between studies were limited by variability in methodologies and outcome measures. As such, we offer recommendations to aid in more standardized reporting for future research.

Dataset Information

Effect of temperature-control liner materials on long-term outcomes of lower limb prosthesis use: a randomized controlled trial protocol.

Publications

Effect of temperature-control liner materials on long-term outcomes of lower limb prosthesis use: a randomized controlled trial protocol.

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