Discuss about the Critical Appraisal of the Evidence.
Stroke is sudden onset of neurological deficit that results in weakness or paralysis on one side of the body. Stroke is the major health concern in Singapore and also is the largest cause of long-term physical disability. The most common problem found in stroke patients is the motor function problems in upper limb. In the case of sub acute stroke, the patient suffers from diminished motor functions; the body also displays weakness on any one side. This weakness of the body on one side is called as hemiplegia. Hemiplegic arm is the condition, where the patient can’t move their arm after stroke. The most common form of providing movement to such arm is the ‘passive range movement’ (Lannin&Ada, 2011 ).
Spasticity and contractures in the upper limb may affect the patients in their daily activities. These problems often start to develop within 6 to 8 weeks post stroke. (Andria, van de port & Meijer, 2013).The exact cause of contractures is undetermined; however some article said that contracture may result from neurological condition example like stroke and Traumatic brain injury. (Beaty& Murphy,2013).After a stroke, spasticity is a common problem in paretic limb that often leads to severe and permanent deformity.(Sheehan, winzer, Mercay & Mudie,2006).When our group members discussed we also found that in Singapore each hospital are using different kinds ofsplints.However wanted to know if splinting was more effective in reducing contractures comparing to positioning. Therefore, the topic was chosen due to interest.Through evidence based practice by comparing hand splinting and hand position, to find which method is more effective in preventing contractures. The selected clinical question is important to be reviewed, because these are the two most common methods that are used in various clinical setting to treat contractures in stroke patients. So decided to choose randomized control trial design. In this design participants are assigned to treatment conditions at random that is they have an equal probability of being assigned to any group.
The article used for the critical appraisal is “Contracture preventive positioning of the hemiplegic arm in subacute stroke patients: a pilot randomized controlled trial”.
Was true randomization used for assignment of participants to treatment groups? The study is the single blind pilot randomized control trial. Yes, the participants was randomly assigned two different groups using opaque, sealed envelopes containing leaflets with either a capital A(experimental group) or a capital B (control group). The participants included in the study, were all the stroke patients, who had to go through the inclusion criteria. The participants, who had been going through the good recovery of the arm, were excluded from the study. The treatment groups used in the study were selected on the basis of the inclusion criteria. The researcher included only those subjects, who had first time stroke defined according to WHO, the participant must have the medial cerebral artery stroke which has been established by means of computerized tomography/magnetic resonance imaging (CT/MRI), The participant should not have any premorbid impairment in the affected arm, should not have severe pain in the arm and should not have used antispasticity drugs, no pain reducing medicine except paracetamol has been used, no planned date of discharge, and must provide the written consent. The methodology used in the study seems to be appropriate for obtaining the desired outcomes. Having a control group verifies the study to be Randomized control trial.
Was allocation to groups concealed? Yes, an independent person carried out the randomization procedure by allocating the groups using opaque, sealed envelopes containing leaflets with either a capital A( experimental group) or a capital B( control group).Therefore, no biasness.
Were treatment groups similar at the baseline? Yes, the participants in the treatment group were similar. All the subjects in both the groups were randomized after the initial selection criteria. All the participants with subacute stroke were selected for the study and patients with severe stroke or other cognitive problems were excluded. The subjects with fair to good recovery of the arm were excluded from the study to avoid any kind of biases. The patients with same stage of the disease and similar co-existing condition were selected. Means of passive range motion were equally compared.
Were participants blind to treatment assignment? No, the participants were not blinded to the treatment assignment. The written consent was taken from the participants. The positioning procedure was carried out for 5 weeks. The subjects in the experiment group were asked to participate in the procedure for another 5 weeks for the purpose of follow-ups. Thus, the subjects were not blinded.
Were those delivering treatment blind to treatment assignment? No, positioning was carried out by the nursing staff under supervision of trained research physical therapists who instructed how the positioning procedure should be carried out.
Were outcome assessors blind to treatment assignment? Yes, Blinding was achieved by reminding the participants before every measurement that they should not reveal allocation to the observers.
Were treatments groups treated identically other than the intervention of interest? Yes, all the subject in the treatment groups received ‘conventional’ rehabilitation treatment, as prescribed by the primary physician of the subject. The subjects in the experimental group were additionally asked to carry out the positioning posture for the five weeks, twice a day for half an hour. Controlled group didn’t receive additional positioning procedure or therapies.
Was follow-up complete, and if not, were strategies to address incomplete follow-up utilized? Yes, follow up of each subject in experimental group and control group were done through every stage of the trial. Follow up was done from the initial screening by the rehabilitation physician till the outcome measurements. If the subjects were excluded from the study for one reason or the other, the reasons were also specifically mentioned separately in the study.
Were participants analyzed in the groups to which they were randomized? Yes, the participants were analyzed in the groups to which they were randomized. The flow of the subjects, through every stage is presented through a chart. Means (standard deviations) of content of treatment sessions and time spent in the positioning procedure at five weeks, were analyzed in both the groups separately.
Were the outcomes measured in the same way for the treatment group? Yes, the outcomes of the treatment groups were measured in the same way. The mean passive range of all the motions were included and represented in the form of table that was measured through hydrogoniometer. The resistances to passive range movements were measured through Ashworth Scale. Resistence to passive stretch in both the groups was measured through Fugl-Meyer Assessment. Barthel Index scores for used for finding ADL-independence in the subjects of both the groups.
Were the Outcomes measured in the reliable way? Yes, the outcomes measured in the study are done in the reliable way, as the same measurement scales were used to measure the outcomes in treatment groups. The study also measured outcomes in reliable way, because the results are clearly stated through comparable charts and also primary and secondary outcomes are clearly mentioned. The positioning procedures were carried out in the presence of the trained physiotherapists and also the measurement scales used in the study are reliable.
Was appropriate statistical analysis was used? Yes, all the statistical analysis has been done by carrying out the SPSS for Windows (version 10.0.5). For this purpose the level of significance was set as P/0.05. p value is the widely used statistical hypothesis. The assumptions of the statistical test were respected
Was the trial design appropriate, and any deviations from the standard RCT design (individual randomization, parallel groups) accounted for in the conduct and analysis of the trial? Yes, the trial design is appropriate, as the study involves the random procedure of assigning the subjects in the experiment and control groups.
The main strength of the study is that it used the reliable way of statistical analysis and measurement of the treatment group outcomes. The major limitations of the study are that the study is underpowered, because the sample size is very small. Another limitation was the positioning procedure was carried out in front of various nurses and four physiotherapists, who have the training of carrying out positioning procedures, but there was a lack of individual assessors, which could have increased the rigour of the methodology.
The key findings from the paper are that positioning of the hemiplegic arm has small beneficial effect on shoulder abduction in passive range of motion (Prabhu, Swaminathan, & Harvey, 2013). The positioning procedures slowed down the development of the shoulder abduction contractures. However, no major difference was found in control group and experiment group. The gap in the knowledge is seen, as effect of positioning procedure on the motor recovery performance, spasticity and independence in ADL’s is still unclear (Skalsky, & McDonald, 2012).
The suitability of the evidences in the clinical setting and implications for the change in practice is evaluated by the use of F.A.M.E. Scale.
F – Feasibility; specifically: The cost effectiveness of the study is that it conducted for the limited period of time to collect the samples. The practice used by the researcher is available and considered as the most reliable practice for preventing contractures in stroke patients. The professionals involved in the study have sufficient experience and skills. The trained physiotherapists are asked to carry out the positioning procedures, which signify the feasibility of the study.
A – Appropriateness; specifically: The practice and procedure used by the study can be considered as culturally safe. The procedure can be considered as transferable to majority of population, as the study was representative of the target population (stroke patients eligible for rehabilitation services). Thus, study is transferable to such settings. However, the study is not easily acceptable to variety of circumstances, as it had particular inclusion criteria since only subacute stroke patients were include and patients with severe stroke were excluded from the study.
M – Meaningfulness; specifically: The meaningfulness of the study is associated with positive outcomes. The study did not mention any kind of negative outcomes. However, the positive outcomes were limited with small slow down in the development of the shoulder abduction contractures. No other positive result was found.
E – Effectiveness; specifically: The beneficial effect of the contracture preventing positioning procedure was very small and no major differences were found in experiment and control groups. However, the practice is safe, as contracture prevention positioning is often supported by various studies (Prabhu, Swaminathan, & Harvey, 2013).
However, this study adds some value to the clinical practice by providing the evidences about the problems (Sanford, 2009). The change in practice can be brought by understanding the problems in the available evidences. The study adds value by explaining the effectiveness of the positioning procedure (Lannin et al, 2007). The current clinical practice continues to use splints for benefitting the people, who have suffered stroke. But, it is important to address that no current research supports or validates the use of splints (Thibaut et al, 2013).
. However, contracture prevention positioning is often supported by various studies. What I consider important for change in practice is that passive stretching has found to be beneficial in improving the range of motion. It is also associated with slowing the development of the contractures. Thus, it can be said that positioning procedure is important in preventing contractures (Dewey, Richard, & Parry, 2011).
The barriers that may hinder the implication of the EBP are the lack of authority to change patient care procedures, insufficient time to apply new practice and difficulty in completely understanding the statistical analysis. These barriers can be overcome by bringing changes on the individual and institutional level. Barriers can be removed by collecting more related evidences, considering client’s value, clinical judgment, clinical decision making and system resources. There is also a need for further research with the qualitative analysis. This kind of trial can help in closing the gap.
Conclusion
The main aim of the paper is to provide the critical appraisal of the selected study through JBI RAPid cghzyshecklist. The critical appraisal of the study by LD de Jong et al (2006) is done. This study is based on finding the effectiveness of the contracture preventing positioning hemiplegic arm in subacute stroke patients. The scope of the study and number of participants is very limited or under powered. The study was carried out on limited numbers of subjects in experimental and control groups. The design of the study is single blind pilot randomized control trial. The evidences provided by the study are very limited, as it excludes number of stroke patients on the basis of inclusion criteria. However, the study is important as it informs about the positioning of the affected limb for preventing contractures. The further and future research requires concentrating on more number of participants. The major problem found in stroke patients is pain. Future research requires developing the study to manage pain in the patients, by preventing contractures. Motor function recovery is the major goal of stroke rehabilitation centers. Motor recovery cannot be achieved without using different clinical treatments. The paper provided the discussion on the basis of substantial research from the reliable resources.
References
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Prabhu, R. K., Swaminathan, N., & Harvey, L. A. (2013). Passive movements for the treatment and prevention of contractures. The Cochrane Library.
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