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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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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:IntroductionThe literature shows that selective carious tissue removal (SCTR) decreases the number and diversity of bacteria, stops the caries process and reduces the risk of pulp exposure. However, no consensus exists on which pulp liner would be suitable for teeth undergoing SCTR. So, this study will verify the in vivo response of dentine-pulp complex after SCTR in primary teeth with or without pulp liner material.Methods and analysisA randomised clinical trial, double-blinded, parallel-group and allocation concealment will be conducted with the enrolment of 384 patients from 5 to 9 years, with one maxillary/mandibular first/second primary molars with deep occlusal/occlusoproximal cavities. The remaining dentine will be lined with calcium hydroxide cement-group 1; mineral trioxide aggregate-group 2 and without liner-group 3. The primary outcome will be success of the of dentine-pulp complex evaluated clinically and radiographically at 6, 12 and 24 months, while the secondary outcomes will be the measurement of the dentine barrier on periapical radiographs. During all study, two trained and calibrated examiners will evaluate the treated teeth clinically and radiographically. Interexaminer and intraexaminer reliability will be verified by casual and systematic error. The Kolmogorov-Smirnov test will be adopted to test the normality of continuous variables. Comparisons among groups will be performed by using the χ2 test and anaylsis of variance, followed by Tukey test (p<0.05). The logistic regression will be applied, and the degrees of this association will be measured using the OR and 95% CI.Ethics and disseminationThe present protocol was submitted and approved by the Ethical Committee of the University of São Paulo, Bauru, São Paulo, Brazil (CAAE: 79123517.0.0000.5417). Consent for publication will be obtained from all parents or legal guardians. Results of this study will be reported in full through peer-reviewed journals.Trial registration numberRBR-9fsxnn.

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

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