Ottawa panel evidence-based clinical practice guidelines for post-stroke rehabilitation.(Special Issue)

Background and Purpose: The purpose of this project was to create guidelines for 13 types of physical rehabilitation interventions used in the management of adult patients (>18 years of age) presenting with hemiplegia or hemiparesis following a single clinically identifiable ischemic or hemorrhagic cerebrovascular accident (CVA). Method: Using Cochrane Collaboration methods, the Ottawa Methods Group identified and synthesized evidence from comparative controlled trials. The group then formed an expert panel, which developed a set of criteria for grading the strength of the evidence and the recommendation. Patient-important outcomes were determined through consensus, provided that these outcomes were assessed with a validated and reliable scale. Results: The Ottawa Panel developed 147 positive recommendations of clinical benefit concerning the use of different types of physical rehabilitation interventions involved in post-stroke rehabilitation. Discussion and Conclusion: The Ottawa Panel recommends the use of therapeutic exercise, task-oriented training, biofeedback, gait training, balance training, constraint-induced movement therapy, treatment of shoulder subluxation, electrical stimulation, transcutaneous electrical nerve stimulation, therapeutic ultrasound, acupuncture, and intensity and organization of rehabilitation in the management of post stroke. Key words: clinical practice guidelines, CVA, epidemiology, evidence-based practice, outcomes, physical rehabilitation, stroke

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Stroke is the third cause of mortality in North America. (1) Although approximately two thirds of stroke patients survive an initial stroke, nearly one half of survivors have physical disabilities as a result. (2) Furthermore, while severe stroke incidence has decreased, milder stroke incidence with minimal and moderate deficits has increased. The individuals surviving a stroke require rehabilitation that includes varying degrees of medical care, rehabilitation, nursing, and other health professional care. (3) Stroke survivors present sensorimotor, musculoskeletal, perceptual, and cognitive system deficits. (4) Their impairments, disabilities, and handicaps can lead to devastating personal consequences as well as consequences for the health care system and society at large.

Post-stroke physical rehabilitation interventions have been used to reduce pain and spasticity, as well as to increase range of motion (ROM), muscle force, mobility, walking ability, functional status, physical fitness, and quality of life. Post-stroke physical rehabilitation interventions are mostly noninvasive interventions that present very few adverse side effects and contraindications as compared with a large number of pharmacologic interventions.

Despite the fact that significant progress has been made in the clinical management of stroke over the last decade, there is an urgent need for physicians, nurses, physiotherapists, occupational therapists, and other rehabilitation specialists to provide the most efficient and effective treatments for their patients.

Evidence-based clinical practice guidelines (EBCPGs) have been defined as systematically developed statements to help practitioners and patients with decisions about appropriate health care for specific clinical circumstances. (5) EBCPGs are a rapidly emerging technology with considerable potential to alter the clinical decision-making process in fundamental ways. The appropriate use of guidelines has been demonstrated to improve both the process of care and patient health outcomes. (6) EBCPGs allow stroke patients to benefit maximally from the physical rehabilitation treatment that they are receiving.

There are currently many systematic reviews and meta-analyses on the effectiveness of post-stroke physical rehabilitation interventions in the scientific literature. (Summarized comparative results of these reviews are included in the Discussion section.) Trials on the efficacy of the following types of therapeutic exercises for stroke survivors have been systematically reviewed: physical fitness, (7,8) therapeutic exercise, (9-14) task-oriented training, (15) progressive strengthening exercise, (16,17) robot-aided training, (18,19) and constraint-induced movement therapy. (20-23) Four meta-analyses have been published (24-27) for the effect of the intensity of rehabilitation following stroke, while reviews on different aspects of gait training, (28) such as the use of the treadmill combined with body support, (29-35) have also been done. Both Barclay-Goddard (35) and Pollock (36) have systematically reviewed balance training. Furthermore, the efficacy of organization and intensity of stroke rehabilitation has been examined through systematic reviews. (37-44)

Several meta-analyses, systematic reviews, and literature reviews have been conducted over the last 7 years on the effectiveness of EMG biofeedback (EMG-BFB). One examined EMG-BFB for neuromuscular reeducation, (45) and others looked at EMG-BFB for the improvement of upper extremity function. (46-48) Finally, Moreland et al. (49) examined the use of EMG-BFB to improve lower extremity function after stroke. These publications, though recent, require updating because of the rapidly growing number of scientific articles published on the effectiveness of EMG-BFB. (50,51) Moreover, one of the studies (45) has been criticized for failing to perform a sensitivity analysis on the control group (49) Follow-up of drop-outs was also lacking. (49) EMG-BFB constitutes a small but effective part of lower extremity physical rehabilitation in stroke patients.

Functional electrical stimulation (FES) has also been systematically reviewed for post-stroke patients. (52,60) A recent review was conducted on the management of shoulder pain and subluxation. (61-63) Meta-analyses on post-stroke pain management were done for acupuncture as an adjuvant therapy in stroke rehabilitation. (64-67) However, several trials of electroanalgesia could have been added to this review. (68,69) To our knowledge, no published systematic review exists concerning the efficacy of therapeutic electrotherapy modalities.

It is evident that the post-stroke physical rehabilitation literature has been exhaustively rewiewed. However, the methodology used in these reviews needs to be standardized (e.g., selection criteria) and quantified (e.g., Cochrane Collaboration), and the results of most of these reviews also need to be updated in order to be included in the development of EBCPGs.

Several multidisciplinary EBCPGs have been published on post-stroke rehabilitation. (70-78) However, the Agency for Health Care Policy and Research's (AHCPR's) EBCPGs were developed for limited clinical practice areas. (70) They did not provide a clear definition of physiotherapy or review specific physical rehabilitation interventions. They also failed to use a rigorous grading system to assess the evidence. Guidelines were based mainly on committee opinions and have not been recently updated. (79) Other EBCPGs (72-78) are also available for rehabilitation specialists. Although the review of the literature and selection of stroke topics is exhaustive in these guidelines, the evaluation of the evidence is based upon descriptive conclusions of the primary studies rather than a quantitative analysis of the raw data. These guidelines use a grading system that takes the research design of the studies into account, but not the clinical significance of the outcomes. Except for the guidelines from the Heart and Stroke Foundation of Ontario, (71) these EBCPGs do not base their assessment of the level of evidence on a quantitative synthesis using the raw data of the studies of interest, such as proposed by the Cochrane Collaboration methodology. These analyses are also not pooled to specific outcome measures. The conclusions of most of these EBCPGs concerning the effectiveness of the selected post-stroke interventions are often imprecise and difficult to apply to the daily practice of rehabilitation practitioners. The advantage of the proposed Ottawa Panel EBCPGs (80-82) on post-stroke physical rehabilitation interventions is that they offer graded, quantitative, (83) and high-quality (84) recommendations that indicate the treatment time for which a specific intervention is optimally effective for a specific outcome for a particular stroke population.

The generally positive (small-to-large effect sizes from quantitative reviews) results from the recent meta-analyses coupled with the lack of up-to-date, rigorously developed EBCPGs on physical post-stroke rehabilitation interventions suggest the need for the development of better quality EBCPGs for these interventions. Furthermore, evidence suggests that quality of care can be improved through the use of EBCPGs. (85-89) The purpose of developing these guidelines is to promote the appropriate use of various physical rehabilitation interventions in the management of stroke survivors. These guidelines are aimed at various users, including physical therapists, occupational therapists, physicians, and patients. This article discusses only post-stroke physical interventions such as therapeutic exercises, task-oriented training, biofeedback, gait training, balance training, sensory interventions, constraint-induced movement therapy (CIMT), treatment of shoulder subluxation, electrical stimulation, transcutaneous electrical nerve stimulation (TENS), therapeutic ultrasound, acupuncture, and intensity and organization of rehabilitation.

Method

The development process of these EBCPGs was similar to that of the Philadelphia Panel (90) and to previous Ottawa Panel publications, (81,82) except that a different target population was used. Briefly, the Ottawa Methods Group (OMG), a group of 10 methodologists with experience in developing EBCPGs, asked professional associations interested in the care of stroke patients to suggest individuals with both clinical expertise in the management of stroke and familiarity with EBCPGs. From among the suggestions, the OMG chose nine experts (R.T., G.G., J.D., J.F., H.C., S.B., L.L., M.S., S.U.) to serve as panel members. The professional experts were recruited from multidisciplinary disciplines such as physical medicine, neurology, occupational therapy, and physical therapy. Several experts (R.T., G.G., J.D., J.F., S.B., L.B., A.H.) are members of the Canadian Stroke Network, (91) while some had already developed post-stroke rehabilitation EBCPGs (R.T., S.B.). The Ottawa Panel consisted of these nine experts, in addition to all the members of the OMG.

The OMG assembled a research and support staff with expertise in meta-analyses, stroke rehabilitation interventions, research methods, or the development and assessment of EBCPGs. The OMG then established an a priori set of inclusion criteria for the study designs, subject samples, interventions, and outcomes to allow the research staff to select the most relevant material as evidence for the effectiveness of various rehabilitation interventions for post-stroke patients. The OMG also reviewed the inclusion criteria to ensure that the approach to the study selection was reproducible and systematic. This a priori protocol guided separate systematic reviews of the literature for each intervention. The OMG also made sure that the Ottawa Panel EBCPGs were methodologically developed at high level of quality, according to AGREE (www.agreecollaboration.org) criteria. (84)

The research staff reviewed articles and created draft evidence tables, which the nine clinical experts received in preparation for their consensus meeting with the OMG. These tables were used as the basis for making the Ottawa Panel recommendations.

Target population

The target population was adult patients (>18 years of age) presenting with hemiplegia or hemiparesis following a single clinically identifiable ischemic or hemorrhagic CVA. The patients had to be medically stable and able to follow simple instructions and to interpret and respond to feedback signals. The mean duration since stroke onset varied from hyper-acute (the first 12 hours), acute (first week following a stroke), subacute (from the first to 6th week), and post-acute (from 6 weeks to 6 months) to chronic (from 6 months) as defined by the Canadian Stroke Network (Appendix 3: Characteristics of Included Studies). (91)

Patients who had been identified as having multiple CVAs, other neurological problems (e.g., Parkinson's, brain tumors, traumatic brain injury), subarachnoid hemorrhages, or subdural hematomas were excluded because of the numerous and varied associated signs and symptoms. Studies that included patients with bilateral neurological signs were also excluded. Further exclusion criteria included studies whose patients presented with one of the following conditions: (1) cancer or other oncological conditions, (2) cardiac conditions, (3) dermatologic conditions, (4) healthy normal subjects, (5) serious cognitive deficits or severe communication problems, (6) major medical problems that could interfere with the rehabilitation pfOcess or incapacitate functional status, or (7) psychiatric conditions. Further inclusion and exclusion criteria are exhibited in Table 1.

Literature search

The library scientist developed a structured literature search based on the sensitive search strategy recommended by The Cochrane Collaboration (92) and modifications to that strategy proposed by Haynes et al. (93) The Cochrane Collaboration method minimizes bias through a systematic Z--proach to the literature search, study selection, and data extraction and synthesis. The search was organized around the condition and interventions rather than the outcomes because it was an a priori search. Thus, we had no control over the outcomes that the authors of the primary studies decided to measure (Appendix 1: Literature Search Results).

The library scientist expanded the search strategy to identify case control, cohort, and non-randomized studies and conducted the search in the electronic databases of MEDLINE, EMBASE, Current Contents, the Cumulative Index to Nursing and Allied Health (CINAHL), and the Cochrane Controlled Trials Register up to December 2004. She also searched the registries of the Cochrane Field of Rehabilitation and Related Therapies, the Cochrane Musculoskeletal Group, the Physiotherapy Evidence Database (PEDro), and the University of Ottawa EBCPGs Web site. Finally, she searched the reference lists of all of the included trials for relevant studies and contacted content experts for additional studies.

In the first round of study inclusion or exclusion, two trained independent reviewers appraised the titles and abstracts of the literature search, using a checklist with the a priori defined selection criteria (Table 1). For each pair of reviewers, individuals independently read the title and abstract of each article and created a list of all of the articles in the database along with a reason for either including or excluding each article. If the reviewers were uncertain about a particular article after having read the abstract, they ordered the article and read it in full before making a determination. Before deciding whether to include or exclude the article, a comparison of their individual lists was performed. A senior reviewer, a methodologist and a clinical expert (L.B.), checked the two independent lists of articles and the reasons for inclusion or exclusion to determine potential inconsistencies. Seven percent of the abstracts needed the consultation of the senior reviewer and an additional review of the problematic article. For the second round of the inclusion and exclusion process, the pairs of reviewers retrieved articles selected for inclusion from the first round and independently assessed the full articles for inclusion or exclusion in the study. Using predetermined extraction forms, the pairs of reviewers independently extracted from included articles data on the population characteristics, details of the interventions, trial design, allocation concealment, and outcomes. The pairs of reviewers assessed the methodological quality of the studies using the Jadad Scale, (83,94) a 5-point scale with reported reliability and validity that assigns 2 points each for randomization and double blinding and 1 point for description of withdrawals. The reviewers resolved differences in data extraction and quality assessment through consensus with the senior reviewer. This consensus served to support the reliability of data obtained with the article selection process.

Study inclusion/exclusion criteria

The inclusion/exclusion criteria were based upon previous criteria used by the Philadelphia Panel. (90) This list of criteria, which had been created for multiple diagnoses, was adapted and approved by the OMG for use with patients post stroke (Table 1).

All original comparative controlled studies that evaluated relevant physical rehabilitation interventions in stroke patients were included: randomized controlled trials (RCTs), controlled clinical trials (CCTs), * cohort studies, and case-control studies. Crossover studies were included, but to avoid potential confounding carry-over effects the data from only the first part of the study (before crossing) was analyzed. Studies where patients served as their own controls were excluded. No limitations based on methodological quality were imposed a priori with regard to the selection of comparative controlled studies; however, the quality of the studies was considered when grading the recommendations resulting from our analysis.

Uncontrolled cohort studies (studies with no comparison group) and case series were excluded, as were eligible studies with greater than a 20% drop-out rate or a sample size of fewer than 5 patients per group. Trials published in languages other than French and English were not analyzed, because of the additional time and resources required for translation. Abstracts were excluded if they contained insufficient data for analysis and additional information could not be obtained from the authors. For further exclusion criteria, see Table 1.

Post-stroke rehabilitation interventions

Post-stroke rehabilitation interventions were identified as therapeutic exercises, task-oriented training, biofeedback, gait training, balance training, sensory information, CIMT, treatment of shoulder subluxation, electrical stimulation, TENS, therapeutic ultrasound, and acupuncture. Intensity and organization of rehabilitation was also included as an intervention related to stroke rehabilitation.

Post-stroke rehabilitation interventions related to therapeutic exercises were identified as aerobic training, resistance training, passive range of motion exercises, proprioceptive neuromuscular facilitation, Bobath technique, kinetron, and the use of the overhead pulley. (95) They are defined as follows. Aerobic training is considered to be activities to increase endurance and cardiovascular function. Resistance training was defined as active exercise done against a resistance. Passive range of motion exercises were defined as physiological mobilization done by the therapist without any effort from the patient. Proprioceptive neuromuscular facilitation was identified as the use of mostly reflex-inhibiting patterns. Bobath technique was defined as a neurodevelopmental technique using inhibitory posture and movement to inhibit spasticity and synergies, while facilitating normal movements. Kinetron training was defined as training with this resistive lower extremity machine, usually in isokinetic mode.

Rehabilitation interventions related to task-oriented training were identified as treatments that involved dividing activities of daily living into component parts. Individual components of the larger task were then practiced until the patient was able to complete the component adequately. Component parts were then combined, and the overall skill was practiced with repetition. Any intervention that divided required tasks into individual skills was included. (95) We included tasks such as seated reaching tasks, adapted games, and repetitive elbow joint movements.

Post-stroke rehabilitation interventions related to biofeedback were identified as EMG-BFB, EMG-biofeedback-relaxation training, rhythmic positional biofeedback, audio and visual feedback, video feedback, and force feedback. EMG-BFB was defined as an intervention that allows a patient to monitor his or her muscle activity through electrodes with a visual or audible feedback signal. (95) Rhythmic positional biofeedback was defined as a usual biofeedback intervention with auditory or visual stimuli aimed at increasing the rhythm of movement. Audio and visual feedback were identified as any cue received by the patient during or after the exercise. Video feedback was considered to be a visual cue from a monitor after the action was done. Force feedback was defined as feedback related to the moment of force.

Rehabilitation interventions associated with gait training were identified as treadmill training, overground training, body weight support training, brace-assisted walking, electrogoniometric feedback training, FES, rhythmic auditory facilitation training, and functional lower extremity training. Treadmill training was defined as ambulation on a treadmill adjusted to patient's comfortable walking speed or highest speed as possible for the patient. Overground training was defined as gait training on an even surface with propulsion forward, backward, and sideways or going up and downstairs. Body weight support training was defined as treadmill training, while an overhead harness supported a percentage of the body weight. Brace-assisted walking was defined as use of hemibar and ankle-foot orthosis (AFO) or any other type of brace if necessary. Electrogoniometric feedback training was defined as auditory feedback during gait training when patient was compensating in hyperextension or flexion. FES was defined as electrical stimulation of a specific muscle or nerve such as tibialis anterior or peroneal nerve for a functional purpose--to improve swing phase or stance phase during gait. Rhythmic auditory facilitation training was defined as imposed rhythm to improve gait rhythm and frequency. Functional lower extremity training was defined as functional tasks such as sitting, standing, climbing stairs, transfers, and gait with a focus on the recovery of stability and gait performance.

Rehabilitation interventions related to balance training were identified as any intervention that contributes to the enhancement of equilibrium and balance in post-stroke patients. We included interventions such as base of support training and platform training.

Rehabilitation interventions related to sensory interventions were identified as any retraining of the sensory and visuo-spatial function to correct posture and perceptual problems after stroke, (95) such as passive vestibular stimulation, perceptual learning exercises, and rocking chair stimulation.

Rehabilitation interventions associated with CIMT were defined as the restriction of the nonparetic upper extremity by a sling or hand splint to encourage the use of the paretic limb. Functional exercises were given to the patient to improve the function of the affected arm.

Post-stroke rehabilitation interventions related to treatment of shoulder subluxation were identified as FES, supports methods, strapping, and shoulder positioning. FE5 was defined as electrical stimulation of a specific muscle or nerve such as supraspinatus or middle deltoid with functional purpose resulting in the reduction of shoulder subluxation. Support methods were defined as any use of an external support such as orthosis or sling to prevent shoulder subluxation. Strapping methods were defined as strapping used to keep the gleno-humeral joint in normal position. Shoulder positioning was defined as a position induced by the physiotherapist to protect the structures around the weak hemiplegic shoulder in order to avoid shoulder pain and shoulder subluxation.

Post-stroke rehabilitation interventions related to electrical stimulation were identified as FES, neuromuscular electrical stimulation (NMES), positional feedback stimulation training, EMG-triggered electrical muscle stimulation, and TENS. FES was defined as the electrical stimulation of a specific muscle or nerve such as tibialis anterior and gastrocnemius for a functional purpose, such as gait training. Neuromuscular electrical stimulation (NMES) was defined as electrical stimulation of a specific muscle or nerve such as thumb flexors and extensors to help trigger nervous fibers and achieve motor recovery. Positional feedback stimulation training was defined as auditory and visual feedback during training to achieve a target position of the joint. EMG-triggered electrical muscle stimulation was defined as electrical stimulation of a muscle triggered by EMG activity of this muscle.

TENS was defined as a form of electrical stimulation that triggers nervous endings to inhibit the message of pain. TENS is identified as being given at high- and low-intensity levels.

Ultrasound was identified as an electrophysical modality using an ultrasonic wave to treat a specific area, usually for pain, and indirectly for ROM.

Post-stroke rehabilitation interventions related to acupuncture were identified as any treatment using needles to stimulate specific anatomical point with the hands or with electrical stimulation.

Post-stroke rehabilitation interventions related to the intensity and organization of rehabilitation were identified as "examining the rate, frequency and rigor of any physical rehabilitation intervention or combination of interventions in the treatment of post-stroke patients." (95) Interventions such as stroke unit care, enhanced physical therapy, enhanced occupational therapy, enhanced upper extremity treatment, and intensive outpatient physiotherapy rehabilitation were included as part of intensity and organization of post-stroke rehabilitation.

Acceptable comparisons were placebo, no treatment, or use of educational pamphlets. Studies designed with a comparison of two interventions instead of treatment versus control were included as long as both interventions respected the inclusion criteria. Concurrent therapies (such as medication) were accepted only if they were provided to both the experimental and control groups. Study selection was not restricted by the cost, complexity, or …