The Preferred Reporting Items for Systematic Reviews and Meta-analysis Protocols (PRISMA-P) guidelines33 and check list (see Additional file 1) were followed in writing this protocol, also PRISMA guidelines will inform the conduct and reporting of the systematic review. Furthermore, in order to promote and maintain transparency, minimize the risk of bias and avoid unnecessary review duplication34 this systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO).
Studies will be selected according to the criteria outlined below;
a. Randomized Control Trials which examined the effectiveness of TST for improving functional ability post-stroke in comparison to a control;
b. Randomized Control Trials which examined the effect of different dosage (intensity and/or frequency) of TST for improving functional ability post-stroke.
c. Published from inception to date.
d. Cross-sectional studies, case series, and case reports will be excluded.
a. Studies examining the general adult humans (presumably 18 years and older)
b. Trials on stroke as defined by the World Health Organization (WHO) as “a syndrome of rapidly developing symptoms and signs of focal, and at times global, loss of cerebral function lasting more than 24 hours or leading to death, with no apparent cause other than that of vascular origin”35
c. Trials involving either of acute, sub-acute and chronic stroke patients or all in a single study.
a. At least an arm of the trial had to include an intervention in which an active motor sequence was done repetitively within a training session, and where the training was aimed at achieving a clear functional goal.
b. Trials which involve multiple movements with functional measurement of outcome.
c. Trials in which the time duration or number of repetitions per a session of training and the number of sessions administered could be identified.
d. Trials that clearly used motor relearning as a whole therapy approach and the amount of task-specific training received can be identified.
e. Trials in which TST is combined with another intervention and the influence of the TST cannot be isolated will be excluded
For all decision making endpoint outcomes, studies should have a follow-up time of at least six months.
There will be no restrictions by type of setting.
No language restriction will be imposed on the search, although only studies in languages other than English that can be translated adequately into English language using Google translate or iTranslate Translator will be included, due to resource limits.
The review will consider studies which included either one or more of the following outcome measures;
a. Upper extremity function:
i. Arm function measures;
ii. Hand function measures;
iii. Sitting balance/reach measures.
b. Lower extremity function/balance:
i. Lower extremity function/mobility measures such as;
ii. Standing balance/reach measures
c. Global motor function measures
i. ADL function measures;
ii. Measures of task performance or impairment;
iii. Measures of quality of life, health status, user satisfaction;
iv. Any adverse effect(s) such as pain, fall, injury, fatigue etc.
Search Methods for Identification of Studies
Literature search strategies will be developed using Medical Subject Headings (MeSH) terms and text key words related to stroke rehabilitation and the use of TST. The following electronic databases will be search for eligible articles published from inception to date;
· Cochrane Central Register of Controlled Trials;
- MEDLINE (PubMed search engine);
- Excerpta Medica dataBASE (EMBASE);
- Physiotherapy Evidence Database (PEDro);
- The Cumulative Index to Nursing and Allied Health Literature (CINAHL);
- Google Scholar.
To ensure literature saturation, reference lists of included studies or relevant reviews identified will be scanned for possible eligible articles.
AHRQ’s Effective Health Care Program36 guidance will be used in developing search strategy.
A three-step approach will be adopted. First, the electronic bibliographic databases will be searched to identify relevant MeSH terms, key words, and index terms, inclusive of the use of Boolean operations, truncation and wild cards. The search strategies relevant to each database will be developed in collaboration with a university librarian.
Secondly, an extensive search of the databases will be conducted using the developed search strategies to identify potentially relevant studies for inclusion.
And lastly, the reference lists of retrieved articles, the International Clinical Trials Registry Platform Search Portal, ClinicalTrials.gov, and PROSPERO would also be searched. Information flow diagram for the review is shown in fig. 1.
Fig. 1: Review Information Flow Diagram
Data Collection and Analysis
Two reviewers would independently screen the titles and abstracts yielded by the search against the inclusion criteria. It would be ensured that the full reports for all titles that appear to meet the inclusion criteria or where there is any uncertainty are obtained. Reviewers would then screen the full text reports together and decide whether they meet the inclusion criteria. Additional information would be sought from study authors where necessary and if possible to resolve questions about eligibility. Disagreement would be resolve through discussion. Record regarding the reasons for excluding trials will be made available. None of the reviewers would be blinded to the titles of journal or to the included study authors or their institutions.
Data Extraction and Management
The results of the literature search will be uploaded to an online Internet based software program (such as DistillerSR, Eppi-Reviewer, Rayyan QCRI etc.) that facilitates collaboration among reviewers during the study selection process. The screening questions will be developed based on the inclusion and exclusion criteria. Citation abstracts and full text articles will be uploaded with screening questions to the software.
Two reviewers would extract data independently, and in duplicate from each eligible study using a detailed instruction manual (DistillerSR) that would be used to inform specific tailoring of an online data abstraction. Data to be abstracted would include participants’ characteristics (personal and clinical), methodology (including trial design, trial size, duration of follow-up), intervention details, the type of control used, dosage, frequency and duration of treatment, any reported adverse effect and all reported patient-important outcomes that are relevant to the review questions.
Assessment of risk of bias in included studies
Two independent review authors will assess the quality of included studies using the Cochrane’s tool for assessing risk of bias,37 any possible disagreements will be resolve by coming together of the two for discussion or by involving a third review author. The following domains will be considered for assessing the risk of bias.
· Blinding of participants, personnel and outcome
· Incomplete outcome Data
· Selective outcome reporting
Other possible sources of bias that would be assessed may include baseline inequality between groups, non-comparable co-interventions between intervention and control groups. Risk of bias for each domain will be graded as described by Higgins et al. as high, low or unclear and justification will be given for each of the grading in the ’Risk of bias’ tables.37
The risk of bias will be summarized for each individual study and across studies using ’Risk of bias’ summary and ’Risk of bias’ graph respectively. The grading for risk of bias of blinding of outcome assessment will depend on the potential influence that lack of blinding may have. A high risk will be assigned if the outcome assessor is reported not blinded and the review authors judge that the outcome measure could be influenced by the assessor. If the review authors judge that the outcome measure could not be influenced by the assessor, a low risk of bias will be assign, irrespective of whether the outcome assessor was blinded or not.
If all necessary data could be obtained from the included studies, a test of heterogeneity will be conducted using the I-squared (I2) statistic. If I2 is less than or equal to 50%, meta-analysis will be conducted, if I2 is greater than 50%, a systematic narrative synthesis will be presented, with information presented in the text and tables to summarize and explain the characteristics and findings of the included studies. The narrative synthesis will explore the relationship and findings both within and between the included studies regarding the effectiveness of the various intensities of TST in improving functional mobility, as well as any adverse effect (s) reported in the management of stroke survivors.