Types of participants
This review will consider all studies that include adult patients aged 18 years and older with a clinical diagnosis of stroke, either hemorrhagic or ischemic, that did not necessarily need to be confirmed using imaging studies, regardless of level of severity and regardless of aetiology,1 undergoing care starting any time after an acute stroke and in any setting.
Types of intervention(s)/phenomena of interest
This review will consider studies that evaluate a novel approach, capable of modulating mechanisms of bilateral cortical reorganization, which is temporary deafferentation.25 It reduces voluntarily the somatosensory input from a body part by temporary anesthesia.
Early studies on deafferentation used a pneumatic tourniquet,26 regional anesthesia,36 or nerve block,25,27-29 to achieve anesthesia. Currently, studies focus on the use of an anesthetic cream (such as Emla®) covered with an occlusive bandage.30-34
The deafferentation can be a stand-alone intervention or serve as an adjunct to a conventional intervention (e.g. usual care, or usual physiotherapy or occupational therapy treatment). Hence, trials will be sought that have the following comparisons: deafferentation alone versus no intervention; deafferentation alone versus conventional intervention; deafferentation alone versus placebo deafferentation (for example using placebo cream); deafferentation with conventional intervention versus conventional intervention alone; deafferentation with conventional intervention versus placebo with conventional intervention; or deafferentation plus other therapeutic or novel intervention versus other therapeutic or novel intervention alone.
Types of outcomes
The primary outcomes are those related to motor function and activity. Specific outcome measures considered include:
- Upper limb function and activity:
- arm function and activity: including assessments such as the Motor Assessment Scale (upper limb), Action Research Arm Test, Wolf Motor Function Test;
- hand function and activity: including assessments such as the Nine Hole Peg Test and Box and Block Test.
- Global motor function: including assessments such as the Motor Assessment Scale.
Secondary outcomes included measures of sensory function of arm and hand (e.g. light touch, mechanical sensation, temperature detection, two-point discrimination), activities of daily living (e.g. Functional Independence Measure, Barthel Index), participation restriction and quality of life (e.g. including assessments such as the SF36, EQ5D, Stroke Impact Scale or other patient-reported outcomes), pain (Visual Analogue Scale or Numeric Rating Scale). We also searched for imaging studies including functional magnetic resonance imaging (fMRI), magnetoencephalography (MEG) and transcranial magnetic stimulation (TMS) and reported adverse effects (e.g. swelling, injury and death).
Types of studies
This review will consider both experimental and epidemiological study designs including randomized controlled trials, non-randomized controlled trials, quasi-experimental, before and after studies, prospective and retrospective cohort studies, case control studies and analytical cross sectional studies for inclusion.
This review will also consider descriptive epidemiological study designs including case series, individual case reports and descriptive cross sectional studies for inclusion in the absence of higher level evidence.
The search strategy aims to find both published and unpublished studies. A three-step search strategy will be utilized in this review. An initial limited search of PUBMED and CINAHL will be undertaken followed by analysis of the text words contained in the title and abstract and of the index terms used to describe the article. A second search using all identified keywords and index terms will then be undertaken across all included databases. Thirdly, the reference lists of all identified reports and articles will be searched for additional studies. Studies published in English, French and German will be considered for inclusion in this review.
Studies published from 1980 to 2013 will be considered for inclusion in this review.
The databases to be searched will include: Australian Clinical Trial Registry (ACTR), Bandolier, Best BETS, BioMed Central, CINAHL, Cochrane Central Register of Controlled Trials, Embase, PubMED, PsiTri, Psychinfo, Mednar, OTSeeker and PEDro.
Individual search strategies will be developed for each database to take into account any differences in thesaurus terminology and indexing.
The search for unpublished studies will include: Dissertation abstracts and Conference proceedings Research and clinical trials register: Clinical Trials, Current Controlled Trials.
Hand searching of relevant journals (e.g. Clinical Rehabilitation, Disability and Rehabilitation, Neurorehabilitation and neural repair, Stroke) and conference proceedings will be performed to reveal additional grey literature and unpublished studies.
Full text articles of studies retrieved in the search will be assessed for relevance against the inclusion and exclusion criteria. Two reviewers will conduct this assessment independently using the JBI web-based assessment tools. Any disagreements that arise between the two reviewers will be resolved through discussion or with a third designated reviewer.
Bibliographic details of the studies will be downloaded or manually entered into an Endnote database (Endnote X5).
The search will be limited to English, but we will consider identified studies in French and German languages where an abstract is available.
Initial keywords to be used for the review will be:
‘stroke' and ‘deafferentation' in the title.
Initial keywords to be used will be:
Cerebrovascular disorder, hemiplegia, stroke, paralysis, paresis, nerve block, anesthesia, pharmacological block
Assessment of methodological quality
Papers selected for retrieval will be assessed by two independent reviewers for methodological validity prior to inclusion in the review using standardized critical appraisal instruments from the Joanna Briggs Institute Meta Analysis of Statistics Assessment and Review Instrument (JBI-MAStARI) (Appendix I). Any disagreements that arise between the reviewers will be resolved through discussion, or with a third reviewer.
Data will be extracted from papers included in the review using the standardized data extraction tool from JBI-MAStARI (Appendix II). The data extracted will include specific details about the interventions, populations, study methods and outcomes of significance to the review question and specific objectives. Authors of primary studies will be contacted for missing information or to clarify unclear data.
Quantitative data will, where possible, be pooled in statistical meta-analysis using JBI-MAStARI. All results will be subject to double data entry. Effect sizes expressed as odds ratios (for categorical data) and weighted mean differences (for continuous data) and their 95% confidence intervals will be calculated for analysis. Heterogeneity will be assessed statistically using the standard Chi-square and also explored using subgroup analyses based on the different study designs included in this review. Sub group analysis will also be considered where two or more studies report findings specific to either the immediate acute phase post-stroke or the longer term rehabilitative phase; i.e. studies may be sub grouped based on the stage or status of patients as well as the timing when the intervention is being administered. Sub group analysis will also be considered based on arm and hand (e.g. proximal upper limb - shoulder/elbow; distal upper limb - wrist and hand/fingers) where the data available permits. Where statistical pooling is not possible, the findings will be presented in narrative form including tables and figures to aid in data presentation where appropriate.
Conflicts of interest
There is no conflict of interest regarding this systematic review.
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Appendix I: Appraisal instruments
MAStARI appraisal instrument
Appendix II: Data extraction instruments
MAStARI data extraction instrument