Professional Documents
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1
Division of Neurosurgery, Departments of Surgery, Prince of Wales Hospital, the Chinese University of Hong Kong,
Hong Kong, PR, China, 2Department of Rehabilitation Science, Applied Cognitive Neuroscience Laboratory,
The Hong Kong Polytechnic University, Hong Kong, PR, China, and 3Shatin Cheshire Home, Hong Kong, PR, China
Abstract
Objective: To evaluate the effects of an increase in the intensity of rehabilitation on the functional outcome of patients
For personal use only.
Keywords: Traumatic brain injury, rehabilitation, intensity, Functional Independence Measure (FIM), Glasgow Outcome Scale
(GOS), Neurobehavioural Cognitive Status Examination (NCSE)
Correspondence: W. S. Poon, Chief in Neurosurgery, Department of Surgery, Prince of Wales Hospital, Shatin, N.T., Hong Kong, PR China.
Tel: (852) 2632 2638. Fax: (852) 2637 7974. E-mail: wpoon@cuhk.edu.hk
ISSN 0269–9052 print/ISSN 1362–301X online ß 2007 Informa UK Ltd.
DOI: 10.1080/02699050701468941
682 X. L. Zhu et al.
outcome of TBI patients [9, 10, 13–17]. The In a subsequent systemic review by the same group
findings, however, are largely inconsistent. in 2004, positive results in regard to functional
Blackerby [9] compared retrospectively the length outcome were produced when the intensity of
of stay of TBI patients before and after an increase in rehabilitation was increased for post-stroke patients
the intensity of rehabilitation (from 5–8 hours per [19, 20].
day). The results showed that the length of stay In an attempt to answer the question of whether
decreased by 31% for both coma and acute groups intensive rehabilitation changes the outcome of
in two hospitals. Spivack et al. [10] examined the patients who have suffered from TBI, this study
combined effect of intensity of treatment and length carried out a prospective randomized assessor-blind
of stay on 95 TBI patients. The results showed trial to compare the functional outcome of two
that TBI patients who received a more intensive and groups of patients with TBI receiving different
longer period of rehabilitation had greater intensity levels of rehabilitation at the early
progress both cognitively and physically. In another post-traumatic stage. It quantified the intensity of
retrospective study [13], the intensity of rehabilita- rehabilitation in terms of the number of hours of
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tion in terms of hours of therapy per day was professionally supervised training received by the
analysed against functional status on discharge. patients each day. The intensive rehabilitation
No benefit related to the intensity of therapy schedule was set at 4 hours of training, whereas the
was found. Two randomized controlled trials have control schedule was set at 2 hours, which was the
addressed the added benefits of enhanced rehabilita- original programme received by existing patients.
tion input [15, 16]. Shiel et al. [15] conducted The interim results of the study have been reported
a prospective two-centre study of 60 moderate- elsewhere [21]. This paper reports the final results.
to-severe TBI patients with routine therapy of,
respectively, 580 and 402 minutes per week in the
two centres. Additional therapy was provided by Patients and methods
experienced healthcare professionals. The outcome
For personal use only.
multi-disciplinary team in designated treatment ADL and facilitate reintegration into home and
areas. Leisure activities and/or extended training community settings. The programme consisted
were provided by the nurses in the patients’ wards. of physical and sensori-motor training from phy-
siotherapy, functional re-training such as self-care
Patients and instrumental ADL, psycho-social re-training
including social skills from occupational therapy
All TBI patients admitted to the Prince of Wales
and hearing and speech from speech therapy.
Hospital were screened for their eligibility to
The content of the programme was tailored to fit
participate in the study. The inclusion criteria
each individual patient’s needs and status. The case
were: (1) suffering from moderate (Glasgow Coma
therapists made adjustments to the programme
Score [GCS] 9–12/15) or severe (GCS 8/15) TBI
according to the patient’s progress. The criteria by
and (2) aged between 12–65 years old. The
which the intervention was upgraded were based
exclusion criteria were: (1) suffering from severe
on established standards that were the same for
medical disease or other associated injury that may
both groups. This was deemed to be an essential
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ments were conducted at the acute hospital (see of OT delivered in the afternoon. In addition, one
below for the outcome measures). The study was unit of speech therapy was provided to the patients
also explained to the patient’s relatives or guardian in the control group and two units of speech therapy
for their support and cooperation. The patients were were provided to the patients in the intensive group.
then randomly assigned to intensive or control The attendance, unit of training received, progress
groups using stratified blocked randomization. The and upgrading status of each patient were recorded.
patients were first stratified according to the severity The duration of the training programme varied
of the brain injury (moderate or severe) and then with respect to the progress made by the patients.
pooled into groups of 10. Randomization was However, the maximum duration of training
conducted separately for each of the moderate- was limited to 6 months. To avoid bias, a neuro-
to-severe sub-groups by drawing one of several surgeon blinded to the study was responsible for
double-sealed envelopes. The number of envelopes deciding whether to discharge the patients from
assigned to the intensive or conventional groups in the programme. The criterion set was that a patient
each randomization was kept as equal as possible. could (1) perform self-care activities of eating,
The randomizations were conducted by a research grooming, dressing, toileting; (2) move from bed
assistant who was not involved in the clinical to chair/wheelchair/shower chair independently;
management. The patients, along with the sealed (3) handle household appliances safely; and
envelopes, were then transferred to the rehabilitation (4) walk with or without aids within ward indepen-
hospital where the rehabilitation programme was dently. Upon discharge, all patients were referred to
carried out. All patients were assessed by the same the out-patient rehabilitation service of the hospital,
multi-disciplinary rehabilitation team before the which offered a 2-hour follow-up rehabilitation
treatment protocol assignment, as indicated in the programme each week. Those patients who did not
sealed envelope, was revealed. Those patients who meet the discharge criterion after 6 months were
were assigned to the intensive group received a total discharged to a long-term care institution or a home
of 4 hours of rehabilitation training, which simply with good family support or continued to stay in the
involved two sets of the 2-hour daily treatment rehabilitation hospital while receiving the existing
protocol that the patients in the control group rehabilitation protocol 2 hours per day.
received.
The comprehensive rehabilitation programme was
Outcome measures
designed with clear clinical outcome targets. All
training provided by the multi-disciplinary team was The primary outcome measure was the Functional
intended to regain function, achieve independence in Independence Measure (FIM), which measures the
684 X. L. Zhu et al.
independence of patients in self-care and cognitive were analysed by repeated measures ANOVA.
functions (maximum total score ¼ 126) [22]. The significance level for all tests was set at
The secondary outcome measures included the p 0.05. The sample size of 68 cases—34 cases in
Glasgow Outcome Scale (GOS) [23] and the each group—was found to yield a power of 0.80
Neurobehavioural Cognitive Status Examination ( ¼ 0.05, one-tail) for detecting a mean FIM score
(NCSE) [24]. The GOS classifies the outcomes difference of 18 or more (equivalent to one level
after brain injury into death (1); vegetative state of independence).
(2); severe disability in which the patient cannot
independently perform ADL (3); moderate disability Ethical approval
in which the patient can independently perform
The study was approved by the Ethical Committee
ADL but is not able to return to work or to resume
of the hospital.
a normal social life (4); and a good recovery in which
the patient is able to return to gainful employment,
either their previous employment or a modified
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Results
type of employment, or is able to resume a normal
social life (5). The NCSE assesses the cognitive One hundred and forty-nine patients with moderate-
functions of language, construction, memory, to-severe TBI, aged 12–65 years, were admitted
calculation and reasoning [24]. The Chinese version to the Prince of Wales Hospital between January
of the NCSE was used in this study, its validity, 1996 and August 1998. Of these, 81 patients
as well as its sensitivity in stroke patients, having (moderate ¼ 17, severe ¼ 64) were excluded from
been previously evaluated [25–27]. the study for various reasons (Figure 1). Among the
All assessments were conducted in the acute 68 patients who were selected for the study, 32 were
hospital by personnel who were not involved in the randomly assigned to the intensive group and 36 to
randomization and who did not provide the rehabi- the control group. One patient in each group was
litation training. The assessment occasions were: at discharged home upon their own request before
For personal use only.
the baseline, at monthly intervals after the baseline reaching discharge status. They had both completed
up to the 6th month and at bi-monthly intervals from the whole assessment. Of the five patients who did
the 8th to the 12th month. The patients either not complete one assessment occasion after their
travelled back to the acute hospital as day patients or discharge, four explained that it was because they
transferred from the rehabilitation hospital if had returned to work. Subsequently, they were
they had not been discharged. The GOS was asked to complete the GOS and FIM via the
conducted by a neurosurgeon; the FIM by the phone. The fifth patient who missed the 4-month
multi-disciplinary team composed of a nurse, a assessment was due to be admitted to a psychiatric
physiotherapist, an occupational therapist and hospital for his behavioural problems. The FIM
a speech therapist; and the NCSE by an occupa- scores of this patient were treated as missing in the
tional therapist. All assessments were completed 4-month assessment.
in less than 1 day. The demographic and medical characteristics of
the 68 patients are listed in Table I. No statistically
significant differences were found between the two
Statistics and data analysis
groups of patients in terms of their demographic
All data were collected prospectively and SPSSR characteristics, severity of TBI, DNO and number of
was used for statistical analysis. Chi-square days requiring ICP monitoring. All patients were in
or Fisher’s Exact Test was used to test the good health prior to the injury and were either
between-group differences in demographic and workers or students. The mean length of stay in the
medical characteristics and other clinical outcome acute hospital, calculated as the time interval
measures: sex, severity by GCS, proportion of between the date of injury and randomization, was
patients requiring intracranial pressure monitoring, 22 days for both the intensive and control groups.
proportion of patients reaching a maximum GOS The mean FIM total scores of the patients in
score (5, good recovery) and proportion of the intensive group increased from 46 (SD ¼ 28)
patients reaching a maximum FIM total score at admission to 115 (SD ¼ 27) at the 6th month
(126). The age of patients was tested by a t-test. to 116 (SD ¼ 27) at the 12th month. This was
The Mann-Whitney Test was used to test the similar to the scores of the patients in the control
between-group differences in days of not obeying a group, which increased from 52 (SD ¼ 32) at
command (DNO)—indicated duration of the coma, admission to 117 (SD ¼ 16) at the 6th month to
days of intracranial pressure (ICP) monitoring, 119 (SD ¼ 11) at the 12th month. Repeated
length of hospital stay (LOS) and FIM and NCSE measures ANOVA indicated that the between-
scores. Sequential FIM and NCSE mean scores group effect was statistically non-significant
Does intensive rehabilitation improve the functional outcome of patients with TBI? 685
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( p ¼ 0.775). The FIM results were further analysed 2nd month (2 ¼ 4.566, df ¼ 1, p ¼ 0.034). The
by counting the proportion of patients who achieved same proportion of significant difference was
a full total score (126) at each assessment occasion. observed in the 3rd month between the intensive
Figure 2 shows the trend of increase in the number group (n ¼ 11, 38%) and the control group (n ¼ 5,
of patients across the two groups (from 0–56% in the 14%) (2 ¼ 3.951, df ¼ 1, p ¼ 0.044). The rest of the
intensive group; from 0–53% in the control group). comparisons were statistically non-significant
It appeared that, in the 3rd month, there were ( p ranged from 0.099 at the 1st month to 0.242 at
significantly more patients in the intensive group the 12th month). Such differences appeared to
(n ¼ 15, 47%) who achieved a maximum FIM score diminish after the 6th month (Figure 3).
than in the control group (n ¼ 7, 19%) (2 ¼ 5.824, The mean NCSE total scores of the patients in the
df ¼ 1, p ¼ 0.016). The rest of the comparisons intensive group increased from 24.9 (SD ¼ 24.7)
were all statistically non-significant ( p ranged from at the baseline to 70.3 (SD ¼ 17.8) at the 12th
0.076 at the 2nd month to 0.483 at the 12th month). month. Similarly, the mean NCSE total scores of the
Such a difference seemed to diminish from the patients in the control group increased from 25.4
6-month assessment onward whereby the control (SD ¼ 24.2) to 71.4 (SD ¼ 17.6). Repeated
group caught up with the study group (Figure 2). measures ANOVA did not reveal statistical signifi-
Similar to the FIM, the results of the GOS showed cance in the between-group differences in the scores
that there was an increasing trend of patients ( p ¼ 0.775). When counting the number of patients
achieving a maximum GOS score across the who achieved a total score of 78 or higher on the
12-month period (Figure 3; 0–53% in the intensive NCSE, there was a slightly larger proportion
group and 0–42% in the control group). There were of patients that reached such scores in the
significantly more patients in the intensive group intensive group (0% at admission and 75% at the
(n ¼ 9, 28%) than in the control group (n ¼ 3, 8%) 12th month) than in the control group (0% at
who achieved a maximum GOS score at the admission and 63% at the 12th month). However,
686 X. L. Zhu et al.
Sex
M 78% (28) 84% (27) 0.703 (x2)
F 22% (8) 16% (5)
Age
Mean (SD)1 36(13) 31(13) 0.149 (t-test)
Severity of head injury by Glasgow Coma Scale (GCS)
Severe TBI 58% (21) 69% (22) 0.992 (x2)
Moderate TBI 42% (15) 31%(10)
Days of not obeying command (DNO)
Range 1–90 1–90 0.825 (Mann–Whitney test)
Median 7 7
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CT pattens2
I 5% (2) 12% (4)
II 42% (15) 38% (12)
III 14% (5) 28% (9)
IV 3%(1) 6% (2)
V total 3(,%(13) 16%(5)
V with EDH3 17% (6) 6% (2)
Number of cases requiring intracranial (ICP) monitoring
75% (27) 69% (22) 0.762 (x2)
Days of ICF monitoring
Range 7–11 3–22 0.426 (Mann–Whitney test)
Median 7 7
For personal use only.
Mechanism of injury
Traffic accident 72% (26) 71.9% (23) 0.98 (x2, all mechanisms)
Industrial injury 5.6% (2) 6.3% (2)
Assault 5.6% (2) 9.4% (3)
Other 16.7% (6) 12.5% (4)
1
SD ¼ Standard deviation.
2
Classification of head injury (type I to V) according to CT findings45.
I: Diffuse injury 1 (no lesion), II: Diffuse injury II (small lesions), III: Diffuse injury III (swelling), IV (midline shift), V: Evacuated or
non-evacuated mass lesion.
3
Percentages of EDH for the whole conventional and intensive groups respectively; EDH ¼ Epidural haematoma.
Figure 2. Percentage of patients who achieved a maximum FIM Figure 3. Percentage of patients who achieved a score of 5 on
score vs. time (months post-randomization). Statistical signifi- GOS (good recovery) vs. time (months post-randomization).
cance was demonstrated at the 3rd month. Statistical significance was demonstrated at the 2nd and 3rd
months.
no statistically significant difference was found (Figure 4). Similar results were found for the
in the proportions of patients between the length of stay variable. The mean length of stay of
two groups (2 ¼ 0.868–0.980, df ¼ 1, p ¼ 0.290 at patients at the acute hospital was the same for both
the 1st month to 0.234 at the 12th month) the intensive and control groups, namely 22 days
Does intensive rehabilitation improve the functional outcome of patients with TBI? 687
Conventional Intensive
group group p2
not able to be discharged after six months for any reason, the LOS was counted as 180 days.
There were three such patients in the conventional group and two in the intensive group.
readiness and the intensity of rehabilitation. It is approximation of the two curves rather than
intuitive that patients who had reached a satisfactory the diminishment of the effect in the study group.
level of recovery of neurological and cognitive The different nature of brain damage and the
functions could have been involved in a more different ages of patients might have contributed to
intensive rehabilitation protocol. The small sample the differences.
size of this study did not enable one to further break As in other studies, the FIM results
down patients based on whether they got maximum obtained in this study suffered from the ceiling
or less than maximum scores and compare their effect [26, 31, 32]. As a result, those patients who
demographic and medical characteristics. Future had a greater ability to perform more complicated
studies could address this interesting research daily tasks than self-care tasks (as measured by the
question. FIM) were not identified by the FIM scores. The
Secondly, the intensive rehabilitation protocol did strategy of using the proportion of patients who had
not seem to increase the potential of functional attained a maximum FIM score was found to better
regain, which is reflected in the treatment outcomes reflect the abilities of the patients and, hence, the
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of these patients at the end of this clinical trial. differences between the patients in the two groups.
No significant differences were found in all the It has also been suggested that the spectrum of FIM
clinical outcome measures beyond the 3rd month is inadequate for TBI patients who have
between the two groups. There are several explana- prominent communicative, cognitive and beha-
tions for this phenomenon. First, the patients’ vioural disturbances [2, 33]. Adding the Functional
rehabilitation potential could have been limited by Assessment Measure (FAM), with its assessment of
the extent to which their brain was damaged. cognitive, behavioural, communicative and commu-
Available clinical studies only revealed that early nity functions, to the FIM (FIM þ FAM) may
rehabilitation increases the rate of recovery. There is improve its spectrum in assessing the psycho-social
a general lack of evidence establishing the causal disability of TBI patients [34, 35], especially when
For personal use only.
effect of early rehabilitation on promoting recovery predicting the community re-integration and
of a damaged brain. Secondly, the facilitating employment status of TBI patients [36].
effect seemed to coincide with the duration of the Similar to the FIM results, there were no
intensive rehabilitation programme. The majority of significant differences in the NCSE mean scores
the patients were discharged from the intensive between the two groups. Cognitive function is
rehabilitation programme within 90 days (mean ¼ a known important factor affecting the tendency to
43 days, SD ¼ 45 days). This suggests that the re-enter employment. However, this was not
increase in the rate of functional regain did not reflected in this study, in spite of the fact that more
continue after the termination of the programme. patients in the intensive group returned to work than
The design of this study, however, meant that it was in the conventional group. There are several
impossible to determine whether the same increase possible explanations for this phenomenon. First,
in the rate of improvement would be sustained if the the instruments used in this study to reflect the
intensive rehabilitation was to be continued after clinical outcomes may not be sensitive enough
the patients were discharged from the existing [37–39]. Secondly, there could be other factors
programme. Again, future studies could attempt to that contributed to the different outcomes of the two
address this research question. groups [40–44]. Previous findings suggest that the
In 1980, Garraway et al. [29, 30] reported the NCSE cannot differentiate between those who are
results of a stroke rehabilitation study in which ADL independent only from those who are ADL
intensive rehabilitation was found to improve the independent and at the same time manage to return
patients’ outcome but its effectiveness was not to work [37]. This could be due to the fact that the
sustained. In a randomized controlled trial, a group NCSE does not assess language functions such as
of patients who received more rehabilitation and reading, writing and spelling or other frontal
started therapy earlier achieved a better functional lobe functions such as sustained attention, self-
independence outcome than others after 6 months. monitoring and shifting set in response to environ-
However, after 1 year, this benefit had disappeared. mental cues [24]. Impairments in these areas may
In this study, the difference in the proportion prevent patients from returning to work. There are
of patients who achieved maximum GOS and also many factors that could confound return to
maximum FIM scores between the two groups work as a treatment outcome of TBI patients,
diminished 6 months post-injury. In contrast to the notably behavioural and emotional problems
stroke studies [29, 30], these results show that it is [40–42]. Social isolation and lack of cooperation
the catching up of the control group that leads to the related to personality changes are important factors
Does intensive rehabilitation improve the functional outcome of patients with TBI? 689
that might prevent them from returning to work This study was presented at the International
[43, 44]. Unfortunately, these behavioural and Conference on Neurotraumatology (ICRAN),
emotional outcomes were not measured in this 20–23 November 1999, Taipei, Taiwan, China.
study. The issue of compensation can also be an
important confounding factor for returning to work,
especially after work-related injury. As industrial
injuries, mostly arising from traffic accidents, References
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