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INTRODUCTION
Stroke is a major cause of adult disability throughout the developed world. Stroke
disease also presents a major healthcare cost, consuming about 5% of the National
Health Service (NHS) budget in the UK (Isard & Forbes, 1992), much of which is
due to the cost of caring for disabled inpatients. Any rehabilitation intervention
which can speed recovery and reduce long term disability would have a major
impact on both the individual and the social burden of this disease.
Much of the research evidence from randomised trials in stroke rehabilitation
concerns the organisation of care (Wagenaar & Meijer, 1991aj Langhorne et al.,
1993, 1995) which indicate that organised (stroke unit) care focused on a multidis-
ciplinary team can reduce both mortality and the need for institutional care. In view
of the compelling results currently available, and the difficulties of generalislng
organisational interventions to different centres, it has been suggested that future
trials should focus on more clearly defined components of stroke care (Dennis &
Langhorne, 1994). One particularly good example, which is both relevant and con-
troversial, concerns the intensity of remedial therapy (especially physiotherapy).
Intensive (enhanced) therapy has been the subject of serveral previous trials (see
review by Ashburn et al., 1993). On the basis of that evidence, Wagenaar and
Meijer (l991a, 1991b) formulated a hypothesis that intensive remedial therapy may
be beneficial in the functional recovery after stroke. However, no clear consensus
has yet emerged. One likely reason for this is that, because of the size of rehabilita-
tion treatment effects is usually modest (Pollock et al., 1993), individual trials are
usually not of sufficient size to produce statistically convincing results.
Systematic review, through a process of objectively identifying, collating and
analysing all the available information on a subject, can provide a means of obtain-
ing more reliable conclusions. The term 'meta-analysis' refers to the statistical
process of combining quantative data. The aim of this systematic review is to address
the question of whether more intensive physiotherapy produces greater benefits in
reducing disability. As there is great potential for bias in rehabilitation research (Pol-
lock et al., 1993), we shall focus on studies which have used a true experimental
(randomised controlled) design (Wagenaar & Meijer, 1991a, 199b) with direct com-
parison of intervention and control groups.
METHOD
Literature search
It is important to try and identify all relevant trials. We aimed to identify all ran-
domised controlled trials of physiotherapy after stroke where a physiotherapy inter-
vention was provided at a greater intensity (i.e. more minutes/day of rehabilitation)
than the contemporary 'normal practice'. We did not include trials which predomi-
nantly aimed to compare organisationally different stroke services (Langhorne et al.,
1995), or qualitatively different physiotherapy techniques (see Wagenaar & Meijer,
1991a, 199bj Ashburn et al., 1993j de Pedro-Cuestra et al., 1993).
Physiotherapy after stroke 77
Trials were identified through a variety of search strategies (see Warlow et al.,
1995). In summary, this comprised the following:
The literature search ended in February 1995. Published data were used in most
cases, although unpublished details were provided for one trial (Sivenius et a1.,
1985).
Outcomes
As rehabilitation interventions could possibly influence stroke outcomes in several
different ways, we aimed to obtain data which reflected pathology (case fatality),
impairment (motor scores) and disability (activities of daily living scores (ADL)
scores). We also attempted to include some global assessment of 'deterioration' in
function during the trial period. There were not sufficient data to allow an analysis
of the resulting handicap or influence on quality of life. Because rehabilitation inter-
ventions may have different effects at different times after a stroke (Pollock et al.,
1993), outcome data recorded within four months of a stroke were collected as well
as at the end of the scheduled follow-up period.
Statistical analysis
All the statistical analyses are based on the principle of examining differences
between treatment and control groups which, through a process of randomisation,
are comparable in all features except the physiotherapy intervention they received.
Several standard methods of statistical analysis have been used for the quantitative
review. Dichotomous outcomes (case fatality, combined death or deterioration) were
calculated as odds ratios (ORs) with confidence intervals (Cis) (Peto, 1987). In this
analysis the chance (odds) of an adverse outcome taking place in the treatment
group as opposed to the control group is calculated together with an estimate of the
range of results with which it is compatible (95% confidence interval (95% Cl)).
Outcomes which were expressed as continuous data, usually as the mean and stan-
dard deviation (SD) of various motor and ADL scores, were analysed in two ways:
1. The difference in mean scores (with 95% Cl) between the intervention and con-
trol groups within single trials was calculated and summed for all trials as the
weighted mean difference (Bracken, 1992). As this method of pooling continu-
ous data requires a common outcome measure, we have assumed that the differ-
ent ADL scores from different trials are sufficiently similar to be converted to a
78 Langhorne, Wagenaar and Partridge
standard AOL score (sAOL). The sAOL, which ranges between 0-100, was cal-
culated by use of the following convention:
The same procedure was used to convert the different motor scores to a standard
motor score (sMS) of 0-100. In trials where the SO has been omitted when
reporting mean scores, a representative estimate was imputed by use of the aver-
age Coefficient of Variation from those trials with complete data (Bracken,
1992); thus, trials with no SO reported were ascribed the average value of similar
trials.
2. Confirmation of the findings obtained with the above approach was achieved by
use of the inverse chi-squared method of Fisher (Hedges & Olkin, 1985), which
provides a non-parametric estimate of effect sizes.
RESULTS
We identified a total of seven randomised controlled trials (n=597 patients) of phys-
iotherapy interventions after stroke which fulfilled the review criteria. These trials
(Table 1) were heterogeneous in terms of the aims and objectives of the interven-
tion, the physiotherapy techniques employed, the patient selection, the rehabilita-
tion setting, and the timing of the intervention. However, all examined
physiotherapy interventions which were qualitatively similar but delivered at greater
intensity than the contemporary normal practice. The main confounding factor to
consider, which is likely to influence outcomes, was the organisational setting in
which the physiotherapy was delivered (Langhorne et a1., 1995). For this reason
trials are described as either unconfounded (intervention and control groups man-
aged in the same setting) or confounded (groups managed on separate sites).
• Stem et at. (1970) studied patients who had suffered a stroke up to 5 years previously, but the
median delay was Z9 days (33 in controls). They used a poorly described 'facilitation' exercise
technique which was quantitatively different from that received by controls (there may also
have been some qualitative differences in therapies provided). A minority of these patients (lZ
of 6Z) were apparently allocated on a non-random basis.
Physiotherapy after stroke 79
• Smith et aI. (1981) (The Northwick Park Trial) was an outpatient study which was methodolog-
ically sound but, owing to their rigorous inclusion criteria, included only 11% of patients
referred. There were two levels of therapy (physiotherapy and occupational therapy) - 'inten-
sive' and 'conventional' - which were compared with no routine rehabilitation (home exer-
cises). For the purposes of analysis, the two interventions are considered as separate trials.
• Sunderland et at. (1992) reported a trial of enhanced physiotherapy focusing on the recovery of
arm function; the authors did not anticipate an effect on overal disability. Their patient group
was subdivided by the severity of initial arm impairment. These subgroups are analysed as sepa-
rate trials. The data from the annual review of this trial (Sunderland et al., 1994) were not
included because they were less complete than at the 6-month review.
• The trial of Wade et aI. (1992) studied the effect of outpatient physiotherapy on the mobility of
patients who had suffered a stroke more than 1 year previously. Owing to the crossover design
of that study, we could only include data from the first phase of the study.
• Richards et aI. (1993) reported a small study focusing on the effects of intensive physiotherapy
on mobility. They compared two intervention groups (Experimental- intensive physiotherapy
with gait training; Early conventional - intensive physiotherapy with no emphasis on gait
training) with conventional therapy. These two comparisons were analysed as separate trials.
The other two studies (Peacock et al., 1972; Sivenius et a1., 1985) are con-
founded by the intervention and control patients being managed in different set-
tings. The results from these Rcrs were analysed and presented separately.
Intensity of therapy
The mean amounts of therapy (min/day) were either reported by the authors as min-
utes of therapy per day, or calculated as the amount of therapy per working day during
the first 6 months of the trial. These figures are approximate but indicate that:
The amount of therapy received by controls in some trials exceeded that of the
treatment group in other trials. However, this does not influence the conclusions
because the analysis examines differences within trials.
Stem et al. (1970) Patients with completed Therapeutic exercise pro- Impairment score (Motility Recorded limb strength
stroke and hemiplegia gramme (>80 min/day) Index; range 44.8---0). ADL (dynamometry). Some qualita-
(median time since stroke versus Normal therapy score (Kenny Rehabilita- tive differences in therapy pro-
I month; range 8 days to 5 (40 min/day) tion Institute Self-Care vided, Deaths not explicitly
years) Evaluation; range 0-24). stated. RCT but 12 patients
Deterioration information apparently allocated on a non-
not available random basis
Peacock et aL. (I 972)· Stroke patients (within 2 'Intensive therapy' in a reha- Death. No impairment Also recorded 'vocational
weeks of their stroke) who bilitation unit versus 'Normal score. ADL score (esoteric score'. Intervention group
required rehabilitation therapy' in general wards; no score similar to Rankin managed in a different setting
details on intensity of therapy score; range 0-6). Deterio-
ration defined as a decline
in ADL function
Smith et aL. (1981) Stroke patients on discharge Group 1 - Intensive therapy Death. No impairment Summed ADL scores were
from hospital (median time (41 min/day); Group 2- score. ADL score (North- ascrireda representativeSD
from stroke 35-41 days); able Conventional therapy (22 wick Park Score: range value. Blind outcome assess-
to tolerate intensive therapy min/day); Control- regular 51-17). Deterioration ment i
visits by health visitor with described as a decline in
referral for therapy if neces- ADLscore
~
sary
~
Sivenius et a1. (1985) Stroke in-patients (within 1 'Intensive therapy' (34 Death. Impairment score Also recorded final placement.
week of stroke); able to toler- min/day) in a rehabilitation (Katz & Ford; range 0-48). Intervention group managed -e
1
ate intensive therapy unit versus 'Normal therapy' ADL score (Lehmann; in a different setting. Blinded l
(20 min/day) in general range 0-27). Deterioration outcome assessment '\j
wards described as a decline in
ADLscore
es
i
Sunderland Consecutive stroke inpatients Intensive therapy for the arm
et aL (1992) and outpatients with unilat- (32 min/day) versus Conven-
eral stroke and upper limb tional therapy (20 min/day)
impairment (median time
since stroke 8-10 days)
Pooled analyses
SUBTOTAL
Confounded Trlill
Peacock
Sivenlus
SUBTOTAL
TOTAL
Unconfounded Trial.
SmhII • Group,
Group 2
Sunderland
WIItJe
SUBTOTAl
Confounded TrIaIII
Pucock
SiV8niu1
SUBTOTAl
TOTAL
0 1 2
InlenIlYe TIIerapy Intenslve T1lerapy
- lieu. Wone -
Treatment Effect 2p < 0.01
FIGURE Z: Death or deterioration during physiotherapy trials: intensive versus conventional therapy
input. Results are expressed as the OR (95% Cl) of a patient suffering death or functional deterioration
during the trial. An open diamond (<» represents the pooled OR and 95% CI for a group of trials. The
total for all trials ill shown as a closed diamond (.). The broken vertical line shows the summary OR for
all trials.
Impairment Score
P <0.05
+10
NS
Mean difference
In Impairment +5
score
(Treatment minus
control)
0
-5
-10 i i I
Randomisation 3 12
Disability Score
P < 0.05
+10
NS
Mean difference
in disability score +5
(Treatment minus
control)
0
·5
·10 i I I
Randomisation 3 12
FIGURE 4: Effect of physiotherapy on disability scores: intensive versus conventional therapy input.
Results are presented as the weighted mean difference (WMD) (and 95% CO between the disability
scores in the treatment (intensive therapy) and control (conventional therapy) groups. Statistical sig-
nificance was tested by use of Fisher's Inverse Chi-squared test (see Method above). NS denotes
p<O.05.
pooled estimates were also calculated (figures 3 and 4 for those trials where the phvs-
iotherapy intervention was started, and outcomes measured, in the first 4 months
after the stroke. In this instance the intensive physiotherapy group showed modest
improvements of approximately 5/100 points in both impairment and disability
scores.
Confirmation of these findings was sought by use of the non-parametric inverse
chi-squared method of Fisher (Hedges & Olkin, 1992). The standard motor (sMS)
and ADL (sADL) scores were significantly greater in the intensive therapy group at
the initial assessment (p<O.05) but not at final review (p>0.05). Conclusions were
broadly similar if limited to the five trials (Smith et al., 1981; Sivenius et a1., 1985;
Sunderland et al., 1985; Wade et al., 1992; Richards et al., 1993) which used
'blinded' outcome assessments.
Conclusions were also similar if we excluded the two trials (Peacock et al., 1972;
Sivenius et a1., 1985) which were confounded by the fact that the experimental
groups were managed in different settings.
Physiotherapy after stroke 85
DISCUSSION
the patients were not all accounted for at the end of follow-up, i.e, failure to do an
'Intention-to-treat' analysis. The design of the trials reviewed here precludes a true
intention-to-treat analysis. However, the trend towards fewer patients dying or dete-
riorating in the intensive physiotherapy group suggests that any observed improve-
ment in impairment and disability scores was a genuine treatment effect and not a
spurious consequence of patients dropping out of the trials.
It is now clear that the way in which stroke patient care is organised may have a
major impact on outcomes (Langhorne et al., 1995), and this may have confounded
the results of two trials (Peacock et a1., 1972; Sivenius et al., 1985) where the inter-
vention group was managed in a different setting from the control group. For this
reason these trials were analysed separately and most of the conclusions were based
on the results from the unconfounded trials.
The results of the pooled analysis suggest that intensive physiotherapy may
reduce impairment and disability but that this effect is transient and of limited scale.
If these crude estimates are correct, and the more intensive inpatient physiotherapy
produced a consistent improvement in ADL scores at 4 months post-stroke (equiva-
lent to a l-point change on a Barthel score) would this be of any clinical signifi-
cancel There are two ways in which this could be important. Firstly, a small change
in ADL score can have a disproportionate impact on lifestyle if it means that an
important task, for example, independent toileting, is now possible. Secondly, a
small improvement in ADL score could have a major impact on hospital costs, and
possibly patient satisfaction, if it means that patients can return home at an earlier
time. However, these possibilities cannot be fully evaluated until new trials specifi-
cally address these questions.
The main conclusion of this overview must be that there is inadequate informa-
tion to allow informed decisions about the best level of physiotherapy input after
stroke. There is a trend towards a transient improvement in ADL and impairment
scores, arid possibly a reduction in the combined poor outcomes of death or deterio-
ration, but large randomised trials will be required to resolve these issues adequately.
The overview results could be useful in planning future more definitive trials.
ACKNOWLEDGEMENT
We are grateful to Hazel Fraser and Carl Counsell forinvaluable assistance with literature searching.
APPENDIX
A more complete description of the analytical techniques used could not be pro-
vided because of limitations of space. The authors can provide further information
on request.
Physiotherapy after stroke 87
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J I