Intensity of Task-Specific Training for Functional Ability Post-stroke: Protocol for a Systematic Review


 Background

This study aimed to describe and present detailed protocol of a systematic review aimed at determining available research evidence regarding the intensity, and frequency of task-specific training ( TST ) that can best result in improved motor function and mobility outcomes in both upper and lower extremities in acute, sub-acute and chronic stroke survivors.

Methods

Literature search strategies were developed using Medical Subject Headings (MeSH) terms and text key words related to stroke rehabilitation and the use of TST to search for relevant randomized controlled trials (RCTs). The Cochrane Central Register of Controlled Trials, MEDLINE (PubMed search engine), Excerpta Medica dataBASE (EMBASE), Physiotherapy Evidence Database (PEDro), Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Google Scholar were searched for eligible articles published from inception to date. Two reviewers independently screened the titles, selected appropriate abstract/studies and extracted relevant data as yielded by the search based on the study inclusion criteria. Assessment of the study risk of bias and quality of included studies were appraised using the Cochrane’s tool for assessing risk of bias or other appropriate tools.

Discussion

This paper presented the description of the systematic review methods, and it is expected to guide researchers in conducting systematic review in similar fields of research. Sources of literature search terms and reviewers have been determined.

Systematic review registration

The study protocol has been registered with PROSPERO (130991)

criteria. Assessment of the study risk of bias and quality of included studies will be appraised using the Cochrane's tool for assessing risk of bias or other appropriate tool.
Discussion This paper presented the description of the systematic review methods, and it is expected to guide researchers in conducting systematic review in similar field of research. Sources of literature search terms and reviewers have been determined. Systematic review registration The study protocol has been registered with PROSPERO (130991) Background This review will explore the various intensities for Task-Specific Training (TST) administered in stroke rehabilitation and identify the adequate dose that best promote functional ability in both upper and lower extremities with minimal adverse effect. For the purpose of this review, intensity for TST is c. The number of days per week on which treatment was provided; It is possible that certain amount of TST provided during stroke rehabilitation may have different 3 effect on functional outcomes as compared to other amount administered. For example, a higher intensity of TST administered may promote better outcomes, but it may also be associated with discomfort on the side of the patient, while administering lower intensity may not be adequate to impact on outcomes even though it might not lead to any adverse effect. Also the number of repetitions of TST required to achieve the desired goal in the upper extremity, may differ from that required in the lower extremity.

Description of the Condition
Stroke is a major cause of long-term neurological disability in adults. 1 The majority of people after stroke present with motor function and mobility limitations, with consequent reduction in their physical activity and community participation levels. Although, the prevalence rates of impairment and disability vary according to individuals, but in the acute stage of stroke about half of all stroke survivors present with severe functional problems. 2 In situations where paralysis occur, complete motor recovery occurred in less than 15% of the patients, both for the upper and lower extremities, 3 approximately 65 percent of survivors cannot integrate the affected hand into their usual activities by six months following stroke. 3 In the lower extremity, about 35 percent of stroke survivors with initial paralysis of the leg do not regain useful function, and 20 to 25 percent of all survivors were unable to walk without full physical assistance. 4 These consequences of stroke are of long-standing effects and may require extensive duration management to address its resultant limitations. As the population of stroke survivors increases and the number of survivors with disability and prolonged care needs raises, the need for rehabilitation care will magnify. 5

Description of the Intervention
In an attempt to address the rehabilitation needs and promote functional recovery, a host of contemporary motor learning approaches were developed and are being practiced by therapists managing individuals affected by neurological disorders such as stroke.
The practice of TST is one of the contemporary approaches to stroke rehabilitation. The term TST 4 evolved from the movement science and motor skill learning literature, 6 and can be defined as a training or therapy in which the patient 'practices context-specific motor tasks and receive some form of feedback.' 7 There are other terms used to describe these elements such as 'repetitive functional task practice', 'repetitive task practice', 8 'task-related training' 9 and 'task-orientated therapy'. 10 The use of TST in stroke rehabilitation has been well documented and its effectiveness has been substantiated by plethora of empirical studies. 11,12 In rehabilitation, TST focuses on enhancement of functional tasks performance through goal-oriented practice and repetition. The focus of TST is on training of functional tasks rather than addressing impairment, just as with muscle strengthening. 13

How the Intervention might work
Task-specific training is fundamentally based on the concept that repeated practice brings about learning a specific task. 10 There is increasing evidence of neural plastic changes associated with repeated training, 14 and several aspects of rehabilitation entail repetition of movement. Repeated motor practice has been demonstrated to decrease muscle weakness and spasticity, 15,16 and to form the physiological foundation of motor learning. 17 Repeated practice of challenging movement tasks results in larger brain representations of the practiced movement. 18,19

Why it is important to do this review
Task-specific training has the prospect to be a resource efficient element of stroke rehabilitation, including self-rehabilitation in the home environment or delivery during a circuit class therapy.
Recently, TST is increasingly been used in rehabilitation programs and packages developed for selfrehabilitation among the community-dwelling stroke survivors, 20,21,22 additionally, repetition of movement is the basic mechanism of action associated with the mechanical or robotic devices being developed, 23,24 to assist and increase motor activity. 11 Most of the evidence-based recommended dosages for physical therapy during stroke rehabilitation 25,26,27 are based on duration of active practice rather than number of repetitions in a treatment session. The Canadian Best Practice guidelines for rehabilitation for example, 5 recommended that patients should receive a minimum of three hours of task-specific therapy, five days per week. 26 However, Lee et al., stated that adhering to the repeated practices for a long duration of time often poses challenges to both stroke survivors and healthcare providers. 28 Similarly, it is possible that within three hours one can do few repetitions of TST with long breaks in between and therefore, ended up doing an inadequate number of repetitions that may be required to attain the desired goal, on the other hand it is still possible that within an hour one can perform large amount of TST that could lead to undesired adverse effect such as fatigue and pain, which may subsequently, affect recovery. Additionally, the number of repetition in a session of TST, and the frequency of the sessions per week that is adequate to promote motor learning in the upper extremity, might differ from that of the lower extremity. Therefore, in administering TST during stroke rehabilitation, and particularly, for self-rehabilitation, the number of repetitions of TST per treatment session may arguably be more meaningful as well as more useful than number of hours covered while practicing.
The effectiveness of number of repetitions of TST in a training session for stroke rehabilitation has been investigated in the literature; however, studies were not unanimous on the number of repetitions of TST per session required to produce desired rehabilitation outcome for each of the extremities (i.e. upper and lower extremities). Different studies have used varied number of repetitions per treatment session, 29,30,31,32 however, the number of repetitions needed for optimal human learning without adverse effect is still contentious.
Lang et al., observed that in the delivery of TST during stroke rehabilitation in seven inpatient and outpatient sites around the US and Canada, the average number of repetitions of upper extremity TST per treatment session was 32 (95% CI = 20 -44) while for lower extremity was 37 (95% CI = 296-418). 19 In another study, Birkenmeier, et al., successfully delivered an average of 322 repetitions per TST session. 32 These and other findings, 29,30,31 led to the argument that it is possible current doses of task-specific practice during rehabilitation are not sufficient to drive the neural reorganization needed to promote optimal function post-stroke. 19 Similarly, Birkenmeier, et al., pointed out that the current dose of TST administered during stroke rehabilitation, is in terms of amount lower than what is currently administered in animal models of stroke and in human motor learning studies. 32 This review is designed to conduct a systematic literature search to present available research evidence regarding the intensity (number of repetitions per treatment session) of TST for the improvement of motor function and mobility outcomes in both upper and lower extremities. h. Adverse outcomes.

3.
To determine the effect of TST on acute, sub-acute and chronic stroke.

Methods
The Preferred Reporting Items for Systematic Reviews and Meta-analysis Protocols (PRISMA-P) guidelines 33 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 duplication 34 this systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO).

Setting
There will be no restrictions by type of setting.

Language
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.

Outcome measures
The review will consider studies which included either one or more of the following outcome measures;

Primary outcomes
a. Upper extremity function: i. Arm function measures; ii. Hand function measures; iii. Sitting balance/reach measures. iv. Any adverse effect(s) such as pain, fall, injury, fatigue etc.

Information sources
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. To ensure literature saturation, reference lists of included studies or relevant reviews identified will be scanned for possible eligible articles.

Search strategy
AHRQ's Effective Health Care Program 36 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.

Selection of studies
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 10 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.
· Sequence generation · Allocation concealment · Blinding of participants, personnel and outcome · Incomplete outcome Data 11 · Selective outcome reporting · Other sources of bias 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.

Data synthesis
If all necessary data could be obtained from the included studies, a test of heterogeneity will be conducted using the I-squared (I 2 ) statistic. If I 2 is less than or equal to 50%, meta-analysis will be conducted, if I 2 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.

Discussion
The aim of this systematic review will be to determine the adequate dose (frequency and intensity) of TST for both upper and lower extremities that can promote optimal motor learning among stroke survivors and possible adverse effect the doses have. Also this review would investigate the time of the day when a TST is administered, and determine its effect on outcomes.
The review results may impact on practice, policy and research. Researchers, healthcare providers, and managers can use the findings to improve the delivery of TST as an intervention option for stroke survivors in many ways; first, healthcare providers could use the result in prescribing TST as home program for stroke survivors, second, the result of the review could help researchers in developing and implementing a self-rehabilitation model of TST for community-dwelling stroke survivors, and thirdly, the result could guide managers and developers of mechanical or robotic devices aimed to assist and/or increase motor activity following stroke.

Ethics approval and consent to participate
Not applicable

Consent for publication
Not applicable

Availability of data and materials
Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.

Competing interests
The authors declare that they have no competing interests.

Funding
No funding received for this review.

Authors' contributions
IUL and RI conceived the idea of the review. RI writes the initial draft of the manuscript. IUL and CJ review the initial manuscript, and developed a suitable search strategy. All authors read and approved the final manuscript.