From the Department of Rehabilitation Sciences, Faculty of Physical
Education and Physiotherapy, University of Leuven (H.M.F., W.J. De W.); the
Department of Rehabilitation and Geriatric Medicine, Bürgerspital,
Solothurn (B.E.S., G.A.C.S., R.S.); the Department of Physical Medicine and
Rehabilitation, University Hospital, Antwerpen-Edegem (L.E.V.); the Department
of Physiotherapy, O.L.Vr. Hospital, Aalst (K.D.P.); and the Department of
Physiotherapy, Rehabilitation Center Hof ter Schelde, Antwerpen (G.A. Van H.),
Belgium.
Correspondence and reprint requests to Hilde Feys, Faculty of Physical Education and Physiotherapy, Tervuursevest 101, B-3001 Heverlee-Leuven, Belgium. E-mail Hilde.Feys{at}flok.kuleuven.ac.be
Methods—In a single-blind, randomized, controlled multicenter
trial, 100consecutive patients were allocated to either an experimental
group that received an additional treatment of sensorimotor stimulation
or to a control group. The intervention was applied for 6 weeks.
Patients were evaluated for level of impairment
(Brunnström-Fugl-Meyer test) and disability (Action Research Arm
test, Barthel Index) before, midway, and after the intervention period
and at follow-up 6 and 12 months after stroke.
Results—Patients in the experimental group performed better on
the Brunnström-Fugl-Meyer test than those in the control group
throughout the study period, but differences were significant only at
follow-up. Results on the Action Research Arm test and Barthel Index
revealed no effect at the level of disability. The effect of the
therapy was attributed to the repetitive stimulation of muscle
activity. The treatment was most effective in patients with a severe
motor deficit and hemianopia or hemi-inattention. No adverse effects
due to the intervention were found.
Conclusions—Adding a specific intervention during the acute phase
after stroke improved motor recovery, which was apparent 1 year later.
These results emphasize the potential beneficial effect of therapeutic
interventions for the arm.
The rehabilitation of the upper limb is a challenge. Many therapeutic
approaches are currently available. However, considerable controversy
exists about their effectiveness. Controlled studies designed to
compare neurophysiological treatment approaches,
such as proprioceptive neuromuscular facilitation, neurodevelopmental
treatment, and the Brunnström technique with conventional
treatment, failed to detect any differences in general
outcome8 9 10 and in upper limb
function.11 12 Although no therapeutic advantage
could be demonstrated for one approach over another, conclusions should
be carefully interpreted in the light of some methodological
shortcomings. In most studies, a limited number of patients were
included, reducing the power and thus decreasing the chance of
detecting a statistically significant difference. Insensitive or
inappropriate measures precluded detection of small improvements,
either in function or in quality of movement. On the other hand,
several studies of treatment modalities especially directed at
improving upper limb function (such as the use of slot
machines,13 home therapy
programs,14 strategies to overcome the learned
nonuse of the hemiplegic arm,15 16
electromyographic biofeedback applications,17 18 19 20 21
and different types of electrical
stimulation22 23 24 ) did show positive results.
Some of these experiments had a small sample size, and nearly all
therapeutic interventions were applied to chronic stroke patients.
However, they do suggest that upper limb function can be improved by
therapeutic input. To the best of our knowledge, only two randomized
controlled trials have been set up after acute stroke. In the study of
Crow et al,19 electromyographic biofeedback
facilitated recovery of arm function. However, the beneficial effect
did not persist at follow-up. Sunderland et al25
proved that motor recovery could be improved and maintained by an
enhanced therapy regimen. There is a need for further studies in this
early period, when the surviving brain tissue has the greatest
plasticity.
The present study investigates the effectiveness of a therapeutic
intervention for the upper limb in the acute phase after a stroke,
which emphasized motor and sensory stimulation and normalization of
muscle tone. The treatment modality originates from
Johnstone26 and is an application of one of the
current neurophysiological treatment
approaches.
The primary objective of the study was to evaluate the effect of
additional sensorimotor stimulation on the motor and the functional
recovery of the hemiplegic arm in stroke patients. Other objectives of
the study were (1) to examine if the specific effects of the therapy
(motor and sensory recovery or changes in muscle tone) could explain
the underlying mechanism of the therapeutic intervention, (2) to assess
eventual side effects, and (3) to identify subgroups of patients who
are more likely to benefit from this type of therapy.
Study Design
The number of patients needed for the study was calculated a
priori to ensure sufficient statistical power. The variance and effect
size needed to calculate the number of patients were estimated from the
results of a long-term follow-up study on arm recovery after
stroke.28 This revealed that a sample of 82
patients was necessary to achieve a 90% chance (power=.90) of
detecting a 10% difference (
Clinical evaluations were performed by independent assessors who were
blinded to group assignment and not involved in the routine treatment
of the patients. As the study was multicenter, several assessors
performed the clinical evaluations. For reasons of uniformity, the
assessors practiced jointly to standardize the assessment procedures.
In addition, a detailed instruction booklet was developed.
The procedures followed were in accordance with the ethical standards
of the responsible institutional committee on human experimentation of
each hospital. Informed consent was obtained from all patients
participating in the study.
Treatment Conditions
The experimental treatment was applied with the patient positioned in a
rocking chair. An inflatable splint was used to support the affected
arm. The shoulder was positioned in 80° flexion and slight abduction.
The elbow was in extension and the wrist in dorsiflexion. The distal
part of the splint was fixed with two straps in a gutter. The patients
were asked to perform rocking movements for 30 minutes, pushing with
the heels and/or the hemiplegic arm. The chair was balanced in such a
way that during the rocking movements patients fell slightly forward
and had to actively push backward. Patients were encouraged to do this
with their hemiplegic arm. Initially, the therapist guided the
movements of the rocking chair. Once the patient could control the
movements, he/she performed them independently.
The experimental intervention was hypothesized to contain three major
elements. Motor stimulation through the repeated movements would
facilitate muscle activity. Sensory stimulation was applied through
approximation of different joints (proprioceptive) and through the
varying pressures exerted on the arm through the splint during repeated
movements (exteroceptive). The placement of the arm in a position
contrary to the typical pattern of spasticity was thought to contribute
to a reduction of muscle tone.
The patients in the control group were also positioned in a rocking
chair and rocked for the same period of time. The arm was rested on a
cushion on the patient's lap, and no additional stimulation was given.
To allow for attention, motivation, and expectations regarding the
placebo treatment, patients in the control group received fake short
wave therapy on the shoulder during the 30 minutes of rocking.
The additional therapeutic intervention was performed by the same
therapists for patients in the control and experimental groups to
prevent bias that could be introduced by personality of therapists. All
patients of both groups received the full 30 sessions of treatment.
Evaluation
The main outcome parameters were evaluated before, midway,
and after the intervention period and during a follow-up, 6 and 12
months after the onset of stroke. The section assessing arm recovery of
the Brunnström-Fugl-Meyer test27 was used
to evaluate motor recovery, a measure of the level of impairment. The
test includes items related to movements of the shoulder, elbow, and
forearm (proximal part) and wrist and hand (distal part). The total
scores can vary between 0 and 66. The scale has proven to be sensitive,
reliable, and valid.27 29 30 At the level of
disability, the Action Research Arm test31 was
used to measure upper extremity function, and the Barthel
Index32 to evaluate activities of daily living.
The Action Research Arm test consists of four subscales: grasp, grip,
pinch, and gross movement. The total test contains 19 movement tasks,
and each task is graded on a four-point scale (score range, 0 to 57).
The Barthel Index contains 10 items that measure performance in
self-care and mobility (score range, 0 to 100). Both the Action
Research Arm test and Barthel Index meet the criteria of reliability
and validity.30 31 33
Several additional parameters were evaluated to investigate
specific effects of the intervention. All measures were taken before
and after the intervention and at 6-month follow-up. The proximal and
distal scores of the Brunnström-Fugl-Meyer test were used to
evaluate the effect of the intervention on the proximal versus the more
distal musculature. Sensory function, exteroceptive and proprioceptive,
was assessed in the proximal, intermediate, and distal sections of the
arm, according to the guidelines described by
Bickerstaff.34 The Ashworth
scale35 was used to evaluate muscle tone of the
internal rotators and adductors of the shoulder; the flexors and the
extensors of the elbow; the pronators of the forearm; and the flexors
of wrist and fingers. A total score of the tone in the seven muscle
groups was made (score range, 0 to 28).
Patients were also assessed for eventual adverse effects of the
treatment, such as soft tissue lesions, shoulder-hand syndrome,
subluxation, and shoulder pain. These secondary complications were
evaluated before and after the treatment period. Shoulder pain was also
measured at the 6-month follow-up test. Inferior
glenohumeral subluxation was evaluated by means of an x-ray. Shoulders
were judged as subluxed or not on the basis of a reliable
categorization of Van Langenberghe et al.36 In
all cases of clinical suspicion of a shoulder-hand syndrome, a
triple-phase bone scan was taken to verify the diagnosis. Capsulitis
and impingement were evaluated with the standard shoulder examination
according to Cyriax.37 Capsulitis was diagnosed
if at least a clear movement limitation was found in external rotation
and glenohumeral abduction of the shoulder and if the movement
restriction followed the typical capsular pattern (external rotation of
the arm most limited, followed by abduction and internal rotation). If
clinical signs suggestive of impingement were present, an
ultrasound echography was requested. The diagnosis of impingement
included tendinitis of M. supraspinatus or M. biceps brachii, bursitis
subacromialis, or rotator cuff rupture. Shoulder pain was judged as
being present or absent at rest and during five passive movement
tests as described in the Cyriax evaluation.37 A
total score of the pain experienced during five movements was made
(score range, 0 to 5).
Data were collected at the initial evaluation for the following
characteristics: degree of motor deficit, level of muscle tone, sensory
loss, hemianopia, or hemi-inattention and cognitive function. This
allowed us to determine if certain patients would benefit more from the
experimental intervention than others. For each factor, patients were
classified into two subgroups. Patients were classified as having a
severe (less than 14 points on the Brunnström-Fugl-Meyer test) or
mild (14 points or more) motor deficit, a low (total Ashworth score
<8) or high (score=8 or more) level of muscle tone, a deficit on
tactile sensation or proprioception or not, presenting hemianopia,
or hemi-inattention or not, and presence of a cognitive deficit (score
on Mini Mental State Examination38 lower than 24)
or not.
Statistical Analysis
Several statistical procedures were used to test differences in
improvement over time between the two groups. The statistical test used
depended on the type of measure. A repeated measures ANOVA using a
mixed model approach39 was applied if rating
scales were continuous and met the assumptions of normality. A mixed
model approach allows several covariance structures and
provides a mechanism for handling missing values. For some
parameters (Brunnström-Fugl-Meyer test, total and
proximal score), a logarithmic transformation was performed to obtain a
normal distribution. If the data were not normally distributed and
could not be transformed to normality (Action Research Arm test and
Brunnström-Fugl-Meyer test, distal score), the generalized linear
mixed model39 was applied as an alternative. In
this analysis, the scores were approximated by a Poisson
distribution. A categorical model with repeated
measurements40 was used for dichotomous or
categorical ordinal data (sensory function, secondary
complications).
To identify the patients who had benefited most from the treatment, an
ANCOVA for repeated measures was used, with pretreatment scores serving
as covariate and the prognostic factor (degree of motor deficit, level
of muscle tone, sensory loss, hemianopia, or hemi-inattention and
cognitive function) added to the model as an independent variable.
The ANCOVA allowed adjustment for initial differences between control
and experimental groups for some of the prognostic factors as well as
identification of differences between both study groups after the
therapeutic intervention started.
All statistical procedures were performed with the SAS System.
Patient details of each group are shown in Table 1
Efficacy of the Therapeutic Intervention
The results for the Action Research Arm test and Barthel Index showed a
similar pattern (see Table 2
Specific and Side Effects of the Therapeutic
Intervention
Testing the specific effects revealed only a significant group by time
interaction for proximal and distal motor recovery. No significant
differences were found between the control and experimental groups in
the development of secondary complications.
Prognostic Factors of the Therapeutic Intervention
Table 3
Although patients in the experimental group performed better throughout
the intervention period, differences were only significant at
follow-up. These results are in contrast with some other studies, in
which significant differences were seen immediately after the
intervention but the beneficial effect disappeared at
follow-up.19 41 42 The finding might be explained
by the nature of the therapy. The intervention consisted of repeated
stimulation of muscle activity, which may not have enabled the subjects
to perform voluntary movements involving the whole arm and hand. The
acquired muscle activity, however, provided a necessary basis for the
training of other motor activities, which continued during the
rehabilitation in the follow-up period. This is a possible explanation
for the significantly better outcome of patients in the experimental
group at 6 and 12 months after the stroke onset.
The results on the Action Research Arm test indicate that the effect at
the level of impairment was not generalized to the level of disability.
The Action Research Arm test consists mainly of activities that involve
grasping, gripping, or picking up objects. The intervention applied in
this study was not focused on functional activities. The effect seemed
to be stimulus specific, a result that was also found in other
intervention studies in stroke patients43 and in
patients with Parkinson's disease.44
The difference on the Barthel Index was not significant. This finding
is not surprising because the Barthel Index is an overall index of
functional recovery. For functions related to the upper limb, the
patient may compensate with the nonhemiplegic side. It confirms that
the Barthel Index is an insensitive measure for assessing the effect of
an intervention on the recovery of the upper limb.
All patients with the diagnosis of an intracerebral
hemorrhage were found in the control group, despite the fact
that stratification for the type of stroke had been performed. This was
a consequence of the fact that the randomization procedure was applied
in each hospital separately and the fact that so few subjects suffered
a hemorrhage. Although patients with the diagnosis of
hemorrhage have higher acute mortality than those with
infarctions, it is generally believed that if patients survive, they
have a better functional prognosis.45 In a recent
study, comparison of matched groups revealed that hemorrhagic stroke
patients exhibited no better but somewhat faster functional gains than
their nonhemorrhagic counterparts.46 To the best
of our knowledge, the exact impact of this factor on arm recovery has
not been studied. However, statistical analyses investigating
the effect of the therapeutic intervention on the main outcome
measures, with and without patients with intracerebral
hemorrhage, revealed the same results. Patients were also
stratified according to their initial score on the
Brunnström-Fugl-Meyer test. An almost perfect randomization was
obtained. Both groups were also comparable in the scores on the initial
Barthel Index. It has been shown that the initial motor deficit is a
very important prognostic factor for either
general45 or specific
arm2 28 function outcome.
Several mechanisms of neuronal plasticity have been proposed in an
attempt to explain motor recovery in brain-damaged
patients.47 48 49 However, from this type of study,
it is impossible to identify the neuronal processes underlying the
improved outcome. It seemed more appropriate to find an explanation
based on hypothesized therapeutic elements such as motor and sensory
stimulation and reduction of spasticity. However, our results indicate
that the sensory stimuli did not improve superficial or deep sensation.
The inhibitory position of the hemiplegic arm did not
affect muscle tone as measured with the Ashworth scale. Robichaud et
al50 showed that circumferential pressure applied
by an air splint around the lower leg reduced soleus muscle motoneuron
reflex excitability in subjects with stroke during but not after the
application. These results suggest that muscle tone might have been
reduced during the 30 minutes of rocking. In fact, only motor recovery
in the arm was found to be significantly better in the experimental
group. Therefore, we concluded that the efficacy of the therapy could
be attributed mainly to the repetitive stimulation of muscle activity
in the arm. These results agree with those from two recent
studies,51 52 in which active repetitive motor
training of hand and fingers has proven to be effective. There is
growing evidence that muscle weakness rather than spasticity plays a
dominant role in impairment of active voluntary
movements.53 54 The important therapeutic
implication is that interventions should be directed at recruitment of
muscle activity. Our results support this philosophy. In addition, it
might be crucial to apply this type of intervention as soon as possible
to prevent learned nonuse of the hemiplegic arm. It has been proved
that even among chronic stroke patients, forced use strategies could
reverse the effect of learned nonuse.15 16
A limitation of this intervention is that it trains repetitive
movements without any problem-solving activity. The results suggest a
limited generalization to functional performance. However, more
complex and skillful activities require a certain degree of muscle
recruitment and control. Also from this point of view, the therapy
presented optimally can be included in the acute phase of the
therapeutic program. When patients show some degree of recovery,
therapeutic modalities addressing skillful and goal-directed movements
may be more appropriate to obtain a maximal generalization toward
function.
A complication of the therapy could be secondary damage to the shoulder
joint, such as subluxation, soft tissue lesions, shoulder-hand
syndrome, or shoulder pain due to possible overloading of the shoulder
joint. Although complications did occur, no differences were found
between the two groups. Nevertheless, applying the therapy requires
careful positioning and support of the hemiplegic arm, and supervision
is necessary.
Our results show that the therapeutic intervention was more effective
in patients with a severe motor deficit and hemi-inattention or
hemianopia. On the other hand, patients with a spastic or flaccid arm,
patients with or without sensory loss, and patients with or without a
cognitive deficit seem to benefit equally from this therapy. These are
new and particularly interesting findings. So far, interventions for
the upper limb were found to be more favorable in patients with some
degree of recovery.14 25 In other studies,
patients were only included if they showed a minimal degree of motor
function and/or no serious cognitive deficit or communication
problem.12 14 15 16 17 19 The intervention described
in this study can be applied to different types of patients and appears
to be particularly effective in the most severely affected
subjects.
Once properly seated, the patients can practice on their own. This
allows them to benefit from more therapy and facilitates a more active
role and a sense of responsibility for the treatment. Only a minimum of
input is needed from therapists, and a greater amount of time,
available while patients are in the rehabilitation center, is spent in
treatment.
The hemiplegic upper limb is affected in many stroke patients, and
recovery is often poor. Adding a specific intervention to the routine
treatment procedures in the acute phase after stroke proved to be
effective up to 1 year after the onset of stroke. These results are
encouraging for further treatment directed at stimulation of motor
activity of the hemiplegic arm, and study is needed to determine how
this should be done. Controlled trials are essential to evaluate
critically existing or new therapeutic interventions. An attempt should
be made to identify within the very heterogeneous
population of stroke the most adequate treatment modalities for
subgroups of patients.
Received December 12, 1997;
revision received January 23, 1998;
accepted January 23, 1998.
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© 1998 American Heart Association, Inc.
Original Contributions
Effect of a Therapeutic Intervention for the Hemiplegic Upper Limb in the Acute Phase After Stroke
A Single-Blind, Randomized, Controlled Multicenter Trial
Abstract
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
Background and Purpose—Arm function
recovery is notoriously poor in stroke patients. The effect of
treatment modalities, particularly those directed at improving upper
limb function, has been studied primarily in chronic stroke patients.
The purpose of this study was to investigate the effect of a specific
therapeutic intervention on arm function in the acute phase after
stroke.
Key Words: clinical trials • rehabilitation • stroke
Introduction
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
Several studies have
been conducted to examine the recovery of the hemiplegic arm in stroke
patients. Up to 85% of patients show an initial deficit in the arm.
Three to six months later, problems remain in 55% to 75% of
patients.1 2 3 4 While recovery of arm function is
poor in a significant number of patients, leg function has proven to be
less of a problem. Seventy-five to eighty-three percent of surviving
stroke patients learn to walk again.5 6 This
discrepancy might be due to several reasons. Three quarters of strokes
occur in the region supplied by the middle cerebral
artery.7 As a consequence, the upper limb will be
affected in a large number of patients. Functional recovery of the arm
includes grasping, holding, and manipulating objects, which requires
the recruitment and complex integration of muscle activity from
shoulder to fingers. In contrast, a minimal amount of recovery of the
hemiplegic leg may be sufficient to obtain functional ambulation.
Furthermore, secondary complications such as inferior
subluxation of the glenohumeral joint, shoulder-hand syndrome, soft
tissue lesions, and painful shoulder frequently hinder rehabilitation
of the hemiplegic arm. Another factor that might decrease the
probability of return of upper limb function is the lack of spontaneous
stimulation during functional activities. Each transfer and each
attempt to stand or walk will require bilateral activity in the legs.
In performing upper limb activities, the patient may use the
nonaffected side exclusively.
Subjects and Methods
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
Subjects
All stroke patients admitted consecutively to an acute
medical ward over 2 and 1/2 years—from March 1994 till September
1996—were screened for entry into the study. The criteria for
inclusion in the trial were (1) diagnosis of ischemic brain
damage or intracerebral hemorrhage, (2) an
obvious motor deficit of the upper limb
(Brunnström-Fugl-Meyer27 score on the
subscale of the upper limb lower than 46), (3) ability to sit
independently or with a minimum of support, and (4) ability to perform
the experimental treatment independently. Patients were excluded if
they had a diagnosis of a subarachnoidal or subdural
hemorrhage, a previously completed stroke on the same side, or
a prestroke disability affecting the arm function. Patients were
recruited from several centers in Belgium (University Hospitals of
Leuven, University Hospital and Rehabilitation Center Hof ter Schelde
in Antwerpen, and O.L.V. Hospital in Aalst) and from the
Bürgerspital in Solothurn in Switzerland. All these centers use a
comparable multidisciplinary rehabilitation approach.
For the purpose of the present study, a single-blind,
stratified randomized, controlled design was used. Patients who met the
entrance criteria were admitted into the trial between 2 and 5 weeks
after the onset of stroke. To obtain two comparable groups, patients
were then stratified according to their initial motor score on the
Brunnström-Fugl-Meyer test.27 Subjects were
assigned to group 1 if the Brunnström-Fugl-Meyer score was
between 0 and 10, and to group 2 if the score was between 11 and 45. In
addition, stratification was applied based on the type of stroke to
achieve an equal distribution of patients with hemorrhage and
ischemia (subgroups A and B). Within these four strata (1A, 1B,
2A, and 2B), patients were randomly allocated to either an experimental
or a control group. This schedule was applied separately for each of
the hospitals involved. 
=.05) in improvement between the two
groups in the main outcome measure (Brunnström-Fugl-Meyer test).
This number was increased to 100 in anticipation of inevitable
defaulters.
The therapeutic intervention was carried out on a daily basis (5
days/week) during a period of 6 weeks. Each treatment session lasted 30
minutes. The intervention was in addition to the usual rehabilitation
procedures.
At entry to the study, patient characteristics such as age, sex,
side of paresis, type and onset of stroke, and associated medical
conditions were documented.
The characteristics of the patients in the control and
experimental groups were compared through the use of
ldb2 square tests (nominal data) or unpaired
t tests (continuous data).
Results
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
Subjects
Approximately 1000 patients with a presumed diagnosis of stroke
within the study period were considered for the trial. A major portion
of the patients died, were in a state of coma, or fully recovered in
the first 2 weeks after the onset of stroke. Other patients were
excluded because they were too old and frail or demented for intensive
therapy, they had other serious diseases, or they were referred to
other hospitals early on or sent back to their homes . A final total of
108 patients entered the trial. Eight patients discontinued the
treatment for various reasons. One patient died, another patient hada
second stroke, and for a third patient, the general medical condition
deteriorated to the extent that the treatment was discontinued. In
addition, there was 1 patient with a humerus fracture and 1 with
extreme shoulder pain. Finally, 2 patients were unable to perform the
treatment autonomously, and 1 patient was discharged during the
intervention period. These patients were excluded from further
analysis. The control and experimental groups each consisted of
50 patients. Of the 100 subjects, there were 4 and 10 defaulters,
respectively, at the 6- and 12-month follow-up tests. Of the defaulters
at twelve months post-stroke, seven belonged to the control group and
three to the experimental group. Death (n=3), recurrence of
stroke (n=1), refusal (n=2), and inability to trace (n=1) accounted for
the missing scores in the control group. In the experimental group, 2
patients died and 1 patient got a second stroke. 
. The groups were comparable in terms of
age, sex, and side of paresis. A significant difference between the
control group and the experimental group was found in the average
number of days between the onset of stroke and entry in the trial. The
mean difference between the two groups was 2.6 days, and the range was
equal in both groups. This was not considered to be clinically
important. A greater imbalance, although not significant, was found for
the type of stroke. All patients suffering an
intracerebral hemorrhage belonged to the
control group.
View this table:
[in a new window]
Table 1. Patient Characteristics of the Control (n=50) and
Experimental (n=50) Group
Fig 1 shows the means and standard
errors of the logarithmic scores on the Brunnström-Fugl-Meyer
test for both the control and experimental groups at the time of the
five evaluations. The figure shows a perfect randomization in the two
groups for the initial score. The results of the repeated measures
ANOVA are summarized in Table 2. All
patients improved significantly over the test sessions (time). However,
both groups showed a significantly different pattern of recovery (group
by time interaction). The experimental group showed a greater
improvement in the scores over test sessions if compared with the
control group. Although this pattern started from the second evaluation
and continued onward, post hoc comparisons revealed that differences
were only significant at the 6- (P=.004) and 12-month
(P=.03) follow-ups. The control group improved from 13.9 to
26.0 in the first 6 months and to 30.3 at 12 months. In comparison, the
experimental group improved from 14.0 to 33.4 in the first 6 months to
36.9 at 12 months. This implies a difference in improvement of 7.3
points at 6 months and 6.5 points at 12 months in favor of the
experimental group. Table 3 shows the
distribution of improvement in percentage of the
Brunnström-Fugl-Meyer scores in the control and experimental
groups. At both 6 and 12 months poststroke, the number of patients not
improving or improving by 10% or less was higher in the control group
than in the experimental group.
View larger version (16K):
[in a new window]
Figure 1. Means and SEs of the logarithmic scores on the
Brunnström-Fugl-Meyer test (BFM) for the control and experimental
groups before, midway, and immediately after (post) the intervention
period and at follow-up at 6 and 12 months after stroke.
View this table:
[in a new window]
Table 2. Results of ANOVA for Repeated Measures for the Main
Outcome Parameters in 100 Stroke
Patients
View this table:
[in a new window]
Table 3. Distribution of Percentage Improvement on the
Brunnström-Fugl-Meyer Test at 6 and 12 Months in the Control and
Experimental
Groups 
). The experimental and control groups both
improved over time, but there was no significant difference between
them (group by time interaction).
Results of statistical analyses testing the differences
between control and experimental groups over time (group by time
interaction) for specific and side effects of the intervention are
summarized in Table 4. For some
parameters, the analysis was performed on a smaller
number because some patients could not be tested due to aphasia.
View this table:
[in a new window]
Table 4. Results of Statistical Analyses to Evaluate Specific
and Side Effects of the Therapeutic
Intervention
An ANCOVA for repeated measures was carried out for the
logarithmic scores on the Brunnström-Fugl-Meyer test to identify
the subgroups of patients that benefited most from the therapeutic
intervention. A significant interaction was found between the treatment
group and degree of motor recovery (P=.04) and the presence
or absence of hemianopia or hemi-inattention (P=.02). The
mean logarithmic scores on the Brunnström-Fugl-Meyer test
obtained at the five evaluation sessions for the control and
experimental groups in each of the two subgroups are presented
in Fig 2a and 2b. This figure shows that
differences between the control and experimental groups were larger in
patients with a severe motor deficit and in patients with hemianopia or
hemi-inattention.
View larger version (61K):
[in a new window]
Figure 2. Means of the logarithmic scores on the
Brunnström-Fugl-Meyer test (BFM) for the control (C) and
experimental (E) groups in each subgroup of the prognostic factor
(panel a, degree of motor recovery; panel b, hemianopia or
hemi-inattention) before (1), midway through (2), and immediately after
(3) the intervention period and at follow-up at 6 months (4) and 12
months (5).
Discussion
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
The results of the present study indicate that motor recovery
of the upper limb in hemiplegic stroke patients can be improved
significantly by additional sensorimotor stimulation in the acute
phase. The mean difference in improvement on the
Brunnström-Fugl-Meyer test at 6 and 12 months poststroke between
control and experimental groups was 7.3 and 6.5 points, respectively.
This corresponds to 11.1% and 9.8% of the total
Brunnström-Fugl-Meyer score, a difference that was considered to
be clinically relevant at the outset of the study. The
Brunnström-Fugl-Meyer test27 is based on
the observation that motor recovery occurs according to predictable
stages, each evaluated by a set of items. An improvement of 10% on
this test implies that the patient achieved the next stage in the
recovery process. also shows that the therapeutic effect cannot be attributed to
a few outlying results. More than 40% of the patients in the control
group deteriorated or showed an improvement of less than 10%. In the
experimental group, 85% of the patients improved more than 10% at
6-month follow-up and 90% at 12-month follow-up. The therapeutic
intervention appears to be useful for a large number of stroke patients
with arm paresis.
Acknowledgments
This work was supported in part by a grant from the Nationale
Vereniging tot Steun aan Gehandicapte Personen. The authors wish to
express their gratitude to the heads of departments and all members of
staff of the participating centers for their collaboration. We hereby
acknowledge Prof Dr. W. Pelemans, Prof Dr R. Lysens, Prof Dr H. Carton,
Prof Dr R. Verhaeghe, Prof Dr M. Driessens, Dr P. Cras, Dr J. Broeckx,
and Dr G. Vermeersch. We are also grateful to the physical therapists
(Dra. G. Nuyens, S. Blankart, B. Sallin, and A. Hartmeier) for carrying
out the blind clinical assessments. Special thanks are offered to Prof
Dr M. Vuylsteke, Prof Dr E. Lesaffre, and Dr D. Belmans for their
advice on statistical analyses.
References
Top
Abstract
Introduction
Subjects and Methods
Results
Discussion
References
1.
Bard G, Hirschberg GG. Recovery of voluntary
motion in upper extremity following hemiplegia. Arch Phys Med
Rehabil. 1965;46:567–572.[Medline]
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