A scoping literature review of studies assessing effectiveness and cost-effectiveness of prosthetic and orthotic interventions.

Purpose: Approximately 1.5% of the world's population (∼100 million people) need a prosthesis/orthosis. The objective of the study was to establish an overview of the literature that has examined prosthetic and orthotic interventions with a view to inform policy development.Methods: Fourteen databases were searched from 1995-2015. Studies reporting primary research on the effectiveness or cost-effectiveness of prosthetic and orthotic interventions were examined. Metadata and information on study characteristics were extracted from the included studies.Results: The searches resulted in a total of 28,958 articles, a focus on studies with the words "randomized" OR "randomized" OR "cost" OR "economic" in their citation reduced this total to 2644. Research has predominantly been conducted in Australia, Canada, Germany, Netherlands, UK and USA. A total of 346 randomized controlled trials were identified, with only four randomized controlled trials examining prosthetic interventions. The majority of research examined lower limb orthoses in the adult population and used a wide range of outcome measures.Conclusions: While various international organizations have highlighted the value of providing prosthetic and orthotic services, both to the user and society as a whole, the availability of scientific research to inform policy is limited. Future structured evaluation of prosthetic and orthotic interventions/services is warranted to inform future policy developments.Implications for rehabilitationResearch into prosthetic and orthotic interventions has grown substantially in the last 20 years, with most of this research conducted in a small number of countries and focusing on the use of lower limb orthotics in adult populations.Research to date has utilized an extensive range of outcome measures, the development of agreed standardized sets of outcomes would allow comparison and combination of results in future research.This study highlights the need for further research in this area, especially studies which examine the cost-effectiveness of prosthetic and orthotic provision.

A systematic review of randomised controlled trials assessing effectiveness of prosthetic and orthotic interventions.

BACKGROUND: Assistive products are items which allow older people and people with disabilities to be able to live a healthy, productive and dignified life. It has been estimated that approximately 1.5% of the world's population need a prosthesis or orthosis. OBJECTIVE: The objective of this study was to systematically identify and review the evidence from randomized controlled trials assessing effectiveness and cost-effectiveness of prosthetic and orthotic interventions. METHODS: Literature searches, completed in September 2015, were carried out in fourteen databases between years 1995 and 2015. The search results were independently screened by two reviewers. For the purpose of this manuscript, only randomized controlled trials which examined interventions using orthotic or prosthetic devices were selected for data extraction and synthesis. RESULTS: A total of 342 randomised controlled trials were identified (319 English language and 23 non-English language). Only 4 of these randomised controlled trials examined prosthetic interventions and the rest examined orthotic interventions. These orthotic interventions were categorised based on the medical conditions/injuries of the participants. From these studies, this review focused on the medical condition/injuries with the highest number of randomised controlled trials (osteoarthritis, fracture, stroke, carpal tunnel syndrome, plantar fasciitis, anterior cruciate ligament, diabetic foot, rheumatoid and juvenile idiopathic arthritis, ankle sprain, cerebral palsy, lateral epicondylitis and low back pain). The included articles were assessed for risk of bias using the Cochrane Risk of Bias tool. Details of the clinical population examined, the type of orthotic/prosthetic intervention, the comparator/s and the outcome measures were extracted. Effect sizes and odds ratios were calculated for all outcome measures, where possible. CONCLUSIONS: At present, for prosthetic and orthotic interventions, the scientific literature does not provide sufficient high quality research to allow strong conclusions on their effectiveness and cost-effectiveness.

An algorithm was developed to assign GRADE levels of evidence to comparisons within systematic reviews.

OBJECTIVES: One recommended use of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach is supporting quality assessment of evidence of comparisons included within a Cochrane overview of reviews. Within our overview, reviewers found that current GRADE guidance was insufficient to make reliable and consistent judgments. To support our ratings, we developed an algorithm to grade quality of evidence using concrete rules. METHODS: Using a pragmatic, exploratory approach, we explored the challenges of applying GRADE levels of evidence and developed an algorithm to applying GRADE levels of evidence in a consistent and transparent approach. Our methods involved application of algorithms and formulas to samples of reviews, expert panel discussion, and iterative refinement and revision. RESULTS: The developed algorithm incorporated four key criteria: number of participants, risk of bias of trials, heterogeneity, and methodological quality of the review. A formula for applying GRADE level of evidence from the number of downgrades assigned by the algorithm was agreed. CONCLUSION: Our algorithm which assigns GRADE levels of evidence using a set of concrete rules was successfully applied within our Cochrane overview. We propose that this methodological approach has implications for assessment of quality of evidence within future evidence syntheses.

Interventions for improving upper limb function after stroke.

BACKGROUND: Improving upper limb function is a core element of stroke rehabilitation needed to maximise patient outcomes and reduce disability. Evidence about effects of individual treatment techniques and modalities is synthesised within many reviews. For selection of effective rehabilitation treatment, the relative effectiveness of interventions must be known. However, a comprehensive overview of systematic reviews in this area is currently lacking. OBJECTIVES: To carry out a Cochrane overview by synthesising systematic reviews of interventions provided to improve upper limb function after stroke. SEARCH METHODS: We comprehensively searched the Cochrane Database of Systematic Reviews; the Database of Reviews of Effects; and PROSPERO (an international prospective register of systematic reviews) (June 2013). We also contacted review authors in an effort to identify further relevant reviews. SELECTION CRITERIA: We included Cochrane and non-Cochrane reviews of randomised controlled trials (RCTs) of patients with stroke comparing upper limb interventions with no treatment, usual care or alternative treatments. Our primary outcome of interest was upper limb function; secondary outcomes included motor impairment and performance of activities of daily living. When we identified overlapping reviews, we systematically identified the most up-to-date and comprehensive review and excluded reviews that overlapped with this. DATA COLLECTION AND ANALYSIS: Two overview authors independently applied the selection criteria, excluding reviews that were superseded by more up-to-date reviews including the same (or similar) studies. Two overview authors independently assessed the methodological quality of reviews (using a modified version of the AMSTAR tool) and extracted data. Quality of evidence within each comparison in each review was determined using objective criteria (based on numbers of participants, risk of bias, heterogeneity and review quality) to apply GRADE (Grades of Recommendation, Assessment, Development and Evaluation) levels of evidence. We resolved disagreements through discussion. We systematically tabulated the effects of interventions and used quality of evidence to determine implications for clinical practice and to make recommendations for future research. MAIN RESULTS: Our searches identified 1840 records, from which we included 40 completed reviews (19 Cochrane; 21 non-Cochrane), covering 18 individual interventions and dose and setting of interventions. The 40 reviews contain 503 studies (18,078 participants). We extracted pooled data from 31 reviews related to 127 comparisons. We judged the quality of evidence to be high for 1/127 comparisons (transcranial direct current stimulation (tDCS) demonstrating no benefit for outcomes of activities of daily living (ADLs)); moderate for 49/127 comparisons (covering seven individual interventions) and low or very low for 77/127 comparisons.Moderate-quality evidence showed a beneficial effect of constraint-induced movement therapy (CIMT), mental practice, mirror therapy, interventions for sensory impairment, virtual reality and a relatively high dose of repetitive task practice, suggesting that these may be effective interventions; moderate-quality evidence also indicated that unilateral arm training may be more effective than bilateral arm training. Information was insufficient to reveal the relative effectiveness of different interventions.Moderate-quality evidence from subgroup analyses comparing greater and lesser doses of mental practice, repetitive task training and virtual reality demonstrates a beneficial effect for the group given the greater dose, although not for the group given the smaller dose; however tests for subgroup differences do not suggest a statistically significant difference between these groups. Future research related to dose is essential.Specific recommendations for future research are derived from current evidence. These recommendations include but are not limited to adequately powered, high-quality RCTs to confirm the benefit of CIMT, mental practice, mirror therapy, virtual reality and a relatively high dose of repetitive task practice; high-quality RCTs to explore the effects of repetitive transcranial magnetic stimulation (rTMS), tDCS, hands-on therapy, music therapy, pharmacological interventions and interventions for sensory impairment; and up-to-date reviews related to biofeedback, Bobath therapy, electrical stimulation, reach-to-grasp exercise, repetitive task training, strength training and stretching and positioning. AUTHORS' CONCLUSIONS: Large numbers of overlapping reviews related to interventions to improve upper limb function following stroke have been identified, and this overview serves to signpost clinicians and policy makers toward relevant systematic reviews to support clinical decisions, providing one accessible, comprehensive document, which should support clinicians and policy makers in clinical decision making for stroke rehabilitation.Currently, no high-quality evidence can be found for any interventions that are currently used as part of routine practice, and evidence is insufficient to enable comparison of the relative effectiveness of interventions. Effective collaboration is urgently needed to support large, robust RCTs of interventions currently used routinely within clinical practice. Evidence related to dose of interventions is particularly needed, as this information has widespread clinical and research implications.

Assistive technologies: can they contribute to rehabilitation of the upper limb after stroke?

OBJECTIVE: To systematically identify, review, and explore the evidence for use of assistive technologies (ATs) in poststroke upper limb rehabilitation. DATA SOURCES: AMED, CINAHL, Cochrane Library, Compendex, CSA Illumina, EMBASE, MEDLINE, PEDro, PyscINFO, and Web of Science were last searched in September 2011. STUDY SELECTION: Two independent researchers screened for inclusion criteria (adult poststroke subjects, upper limb rehabilitation with an AT). The risk of bias was assessed. Randomized controlled trials of poststroke subjects with baseline equivalence as assessed by blinded assessors were selected for data extraction. DATA EXTRACTION: Details of subjects, experimental and control treatments, and all outcomes were recorded in a spreadsheet. DATA SYNTHESIS: These data were used to calculate effect sizes for all outcome measures. Impairment measures ranged from -.39 (95% confidence interval [CI], -1.14 to .62) to 1.46 (95% CI, .72-2.20). Measures of activity effect sizes were from .04 (95% CI, -.35 to .44) to .93 (95% CI, -.39 to 2.25); for Motor Activity Log, from .07 (95% CI, -.66 to .80) to 1.24 (95% CI, .47-2.01); and for participation, from -3.32 (95% CI, -4.52 to 2.11) to 1.78 (95% CI, 0-3.56). CONCLUSIONS: AT treatments appear to give modest additional benefit when compared with usual care or in addition to usual care. This is most apparent for subjects early poststroke with 2 caveats: high-intensity constraint-induced movement therapy and electrical stimulation exclusively to the shoulder appear detrimental. The heterogeneity of treatment parameters and population characteristics precludes specific recommendations. Research would benefit from modeling studies to explicitly define criteria of population, intervention, comparator, and outcomes for effective treatments before the development of efficiently integrated care pathways.

Assessment of the risk of bias in rehabilitation reviews.

Systematic reviews are used to inform practice, and develop guidelines and protocols. A questionnaire to quantify the risk of bias in systematic reviews, the review paper assessment (RPA) tool, was developed and tested. A search of electronic databases provided a data set of review articles that were then independently reviewed by two assessors using the RPA. The inter-rater reliability was between moderate and good (κ scores 0.46-0.95). Many reviews did not describe the purpose in terms of population, intervention, comparator and outcome measure (i.e. PICO format), making inter-rater agreement on this question difficult. The RPA discriminated between high-quality reviews and those with a risk of bias (e.g. inadequate reporting of search terms, lack of independent reviewing or inclusion of non-randomized-controlled trials). The RPA questionnaire was revised to ensure that questions (on the basis of clarity of purpose, extent of search, independence of reviewers, randomized-controlled trial inclusion and availability of data) had dichotomous answers so that the positive responses scored one. The risk of bias increases as the score reduces.

The combined effect of Dynamic splinting and Neuromuscular electrical stimulation in reducing wrist and elbow contractures in six children with Cerebral palsy.

The aim of this pilot study was to investigate the feasibility of applying the combination of Dynamic splinting (DS) and Neuromuscular electrical stimulation (NMES) in order to improve wrist and elbow function, and range of motion, in children with upper limb contractures due to Cerebral palsy (CP). Six children aged seven to 16, with contractures at the wrist or elbow, were recruited. Following a 12-week baseline period all participants underwent a 12-week treatment period where DS was used for one hour per day and combined with NMES for the second half of the 1-h treatment. A 12-week follow-up period then ensued. Upper limb function was assessed with the Melbourne assessment, physical disability with the Paediatric Evaluation of Disability Index and the Activity Scale for Kids, and quality of life with the Pediatric Quality of Life Scale. Passive and active range of motion at the wrist and elbow were measured using manual and electrical goniometers. The technique of using combined NMES and DS was demonstrated to be feasible and compliance with the intervention was good. There was an increase in passive elbow extension in two participants treated for elbow contractures, although no accompanying change in upper limb function was demonstrated. Wrist range of movement improved in one participant treated for wrist contracture.

Developing a technique to measure intra-limb coordination in gait: applicable to children with cerebral palsy.

Lower limb intra-limb coordination was investigated using sagittal plane kinematic data extracted from gait data recorded using a Vicon system (Vicon Motion Systems Ltd., Oxford, UK) of 20 normal (N) and 20 children with cerebral palsy (CP). Walking speed, maximum and minimum flexion and range of motion (ROM) were calculated. The repeatability of the data was checked by calculating the coefficient of multiple correlation. Data were also processed to determine angular velocity of hip and knee joints. A logical spreadsheet was devised to determine when both joints moved in the same direction (in-phase), in different directions (antiphase, AP) or if either joint was immobile (JS). In-phase joint motion was further subdivided into in-phase flexion (IPF) and in-phase extension (IPE), which comprises in-phase during stance phase (IPEst) and in-phase during swing phase (IPEsw). Data were processed using two threshold values for angular velocity below which the joint was considered to be immobile. The threshold values used were 0.05 degrees /% of gait cycle and 0.025 degrees /% of gait cycle. Children with cerebral palsy had reduced ROM and walked more slowly than normal children. There are significant differences between N and cerebral palsy coordination phases with marginally greater significance at the 0.05 degrees /% threshold for most component parameters; the exception being in-phase flexion. It is therefore suggested that this threshold value (0.05 degrees /%) is used for future work.

Key factors in the development of lower limb co-ordination: implications for the acquisition of walking in children with cerebral palsy.

PURPOSE: This paper explores differences in walking development between normal children and those with cerebral palsy and discusses their clinical implications. METHOD: A literature review (MEDLINE, RECAL) of walking development in normal children and those with cerebral palsy, including the use of walking aids. RESULTS: Normal neonates display reflexive stepping, at 8 months supported walking and then independent walking emerge at about 12 months. Transition from the wide-based, high stepping gait to narrower base, heel-toe gait with arm swing occurs within 6 months of walking. Gait is mature by 7 years. Children with cerebral palsy have delayed walking. Prognostic factors include retained reflexes, age of head control and of independent sitting. They retain kinematic and muscle activation patterns seen in supported walking. Older children show co-contraction patterns and lose range of motion at leg joints. Walking aids have been studied for energy consumption, but only independent walking patterns are described. Treadmills and partial weight relief have been used for walking training. CONCLUSIONS: Children with cerebral palsy fail to achieve the transition from supported stepping to mature gait patterns. Assessment tools to identify gait maturity need to be developed so that treatment that promotes transitions can be promoted and effectively monitored.