Professional Documents
Culture Documents
Neural Repair
Volume 23 Number 2
February 2009 184-190
© 2009 The American Society of
Motor Training of Upper Extremity With Functional Neurorehabilitation
10.1177/1545968308324548
Background. Functional electrical stimulation (FES) allows active exercises in stroke patients with upper extremity paralysis. Objective.
To investigate the effect of motor training with FES on motor recovery in acute and subacute stroke patients with severe to complete arm
and/or hand paralysis. Methods. For this pilot study, 23 acute and subacute stroke patients were randomly assigned to the intervention
(n = 12) and control group (n = 11). Distributed over 4 weeks, FES training replaced 12 conventional training sessions in the intervention
group. An Extended Barthel Index (EBI) subscore assessed the performance of activities of daily living (ADL). The Chedoke McMaster
Stroke Assessment (CMSA) measured hand and arm function and shoulder pain. The Modified Ashworth Scale (MAS) assessed resis-
tance to passive movement. Unblinded assessments were performed prior to and following the end of the training period. Results. The
EBI subscore and CMSA arm score improved significantly in both groups. The CMSA hand function improved significantly in the FES
group. Resistance to passive movement of finger and wrist flexors increased significantly in the FES group. Shoulder pain did not change
significantly. None of the outcome measures, however, demonstrated significant gain differences between the groups. Conclusions. We
did not find clear evidence for superiority or inferiority of FES. Our findings, and those of similar trials, suggest that the number of ses-
sions should be at least doubled to test for superiority of FES in these highly impaired patients and approximately 50 participants would
have to be assigned to each therapeutic intervention to find significant differences.
From the Balgrist University Hospital, Spinal Cord Center, Zurich, Switzerland (SM, TK); Reha Rheinfelden, Rheinfelden, Switzerland (CS, AZ-S, TE); and
the Automatic Control Laboratory, Swiss Federal Institute of Technology, Zurich, Switzerland (TK). Address correspondence to Sabine Mangold, PhD, Balgrist
University Hospital, Spinal Cord Center/Research, Forchstrasse 340, 8008 Zurich, Switzerland. E-mail: smangold@balgrist.unizh.ch.
184
Mangold et al / FES in Early Stroke Rehabilitation 185
Data Analysis
Note: Six push-button signals trigger this typical grasping cycle to allow
an individual timing. The dashed plateau lines within one step indicate that Data analysis was performed by intention-to-treat. An
the stimulation remains constant until the next step is triggered. The sig- analysis of kurtosis and skewness was done for age, time
nals are the following: (1) anterior deltoid muscle, m. triceps brachii, and poststroke, and number of occupational therapy sessions of
finger extensors are activated (the arm stretches forwards with hand open upper extremity training to select adequate statistical tests for
to reach an object); (2) arm remains stretched and hand closes to grasp an
the evaluation of baseline comparability.
object; (3) hand remains closed and arm muscles relax; (4) arm stretches
to the front while fingers remain closed; (5) arm remains stretched Baseline comparability was evaluated with the following
and hand is opened to release the object; (6) the stimulation of arm mus- statistical tests. Age was tested with the independent t test
cles stops, bringing the arm passively back to the resting position. Once (Levene’s test for equality of variances). Time poststroke and
completed, the cycle can be started anew. number of occupational therapy sessions were evaluated with
the 2-tailed Mann-Whitney U test for nonparametric data,
CMSA score of the paretic arm were selected as primary because they were not normally distributed. This test was also
outcome measures. Each CMSA item score ranges from no used for EBI and CMSA scores (mean baseline values),
or almost no voluntary muscle activity (1 point) to normal because they are ordinal parameters. The number of participants
coordination of movement (7 points). in each group was compared with the χ2 test. The Pearson
As secondary outcome measures, the item “shoulder pain” 2-sided χ2 test was used to evaluate proportional differences
of the CMSA and the Modified Ashworth Scale (MAS) were in both groups regarding gender, diagnosis (hemorrhagic or
Table 1
Extended Barthel Index (Subscore)
Item Item Description Score
Eating and drinking Is unable, or requires a stomach feed tube and is dependent on assistance with device 0
Needs help in cutting and spreading 2
Is independent with adaptive equipment (eg, adapted cutlery handles) 3
Is independent, or requires a stomach feed tube, but can handle device independently 4
Grooming (washing face, Is unable 0
combing, shaving, Needs help with many, but not all procedures 1
brushing teeth) Needs minor assistance (eg, opening the toothpaste tube), or is physically independent, but needs supervision 2
Is independent with adaptive equipment (eg, extension of the hairbrush handle) 3
Is independent 4
Dressing and undressing Is unable 0
(including tying shoes, Needs help with most, but not all articles of clothing, or needs help with all articles of clothing, but assists actively 1
buttoning up) Needs help with only a few procedures (eg, support for tying shoes, donning orthotic devices), or is physically 2
independent, but needs supervision
Is independent (perhaps with assistive devices such as sock aids) 4
Bathing self Is unable 0
Needs assistance with many, but not all procedures, (eg, support for transfers, is able to wash the upper part of the 1
body, but not the lower part)
Needs minor assistance (eg, opening dispensers), or is physically independent, but needs supervision 2
Needs adaptive equipment (eg, bath chair, bath lift), but can use it independently 3
Is independent and needs no adaptive equipment 4
Mangold et al / FES in Early Stroke Rehabilitation 187
Table 3
Baseline Values, Gains From Pretreatment to Posttreatment, and Statistical Group Differences of Primary
Outcome Measures and Modified Ashworth Scale of 2 Muscles that Tend to Become Spastic
Control Group (n = 11) FES Group (n = 12)
Group Differences (P Value)
Outcome Baseline Median Gain Median Baseline Median Gain Median
Measures (Quartiles) (Quartiles) (Quartiles) (Quartiles) Baseline Gain
EBI subscore 5 (4, 5.5) 3** (1, 3.3) 6 (6, 7) 1.5** (0.8, 2) 0.013* 0.19
CMSA arm 1 (1, 2) 1* (0, 1) 2 (1, 2) 0* (0, 1) 0.73 0.57
CMSA hand 2 (2, 2) 0 (0, 1) 2.3 (1, 2.6) 0.3* (0, 0.5) 0.50 1.0
MAS finger flexors 1.5 (0.8, 2) 0 (-0.5, 0.8) 1.3 (0.9, 2) 0.5* (0, 1.1) 0.78 0.17
MAS wrist flexors 3 (1.5, 3) 0.5 (0, 1.3) 2 (1, 2.5) 0.5* (0, 1.1) 0.13 0.68
Abbreviations: FES, functional electrical stimulation; EBI, Extended Barthel Index; CMSA, Chedoke McMaster Stroke Assessment; MAS, Modified Ashworth
Scale.
*P < .05; **P < .01.
Discussion
We investigated changes of upper extremity function in
Abbreviations: EBI, Extended Barthel Index; FES, functional electrical stroke participants with severe paralysis. Control participants
stimulation. received conventional upper extremity motor training.
Distributed over 4 weeks, FES training replaced 12 conventional
therapy sessions in the intervention group. The total number of
Table 4
therapy sessions did not differ significantly.
Effect Sizes (Cohen’s d) of Gains of the Primary Outcome
Primary outcome measures, ie, the EBI subscore and the
Measures From Pretreatment to Posttreatment
CMSA (arm and hand), improved significantly in both groups
Effect Size (Cohen’s d) except for the CMSA hand score in the control group (P =
.06). According to the MCID, only the gains of the EBI
Outcome Control FES
subscore in the control group (3 points) and FES group (1.5
Measures Group Group
points), and the gain of the CMSA arm score in the control
EBI subscore 1.13 0.53 group (1 point) were clinically important. Having 0 to 2 points
CMSA arm 0.78 0.78 per EBI item at baseline, a change of 1.5 points on the EBI
CMSA hand 0.63 0.29
subscore indicates participant fluctuation in 1 or 2 items from
Abbreviations: FES, functional electrical stimulation; EBI, Extended Barthel either being unable to being able to perform some tasks, or
Index; CMSA, Chedoke McMaster Stroke Assessment. needing significant assistance to minor assistance, or requiring
Mangold et al / FES in Early Stroke Rehabilitation 189
minor assistance to achieving independence with adaptive to 47% after 6 months.28 At baseline, most of our participants
equipment (Table 1). In their baseline CMSA arm score, all were without shoulder pain. There was no significant change in
participants but one had 1 or 2 points. For participants starting shoulder pain within the groups during the 4-week program and
at 1 point, an increase of 1 point indicated the achievement of no significant gain difference between either group. Electrical
the ability to resist passive shoulder abduction and to extend stimulation can be used to treat shoulder pain, but our stimulation
the elbow with facilitation. For those who had these functions protocol was not adjusted to this special objective. Furthermore,
at baseline, a change of 1 point indicated the ability to touch beneficial effects of FES become obvious in participants who
the chin and the contralateral knee. already have developed shoulder pain29 and not in groups
The findings are in accordance with other studies on the including only few participants with shoulder pain.12,30
affected upper extremity, showing significant improvements Our study was performed with a small group of patients and
with only conventional therapy or additional electrical stimulation group imbalances weakened the validity of the intergroup
within several weeks after onset.7,22 The effect sizes are the same comparisons. Hence, the following conclusions have to be
magnitude found in comparable studies, eg, 0.65 for the Barthel appraised in this context. In acute, severely affected stroke
Index23 or 0.73 for the Fugl-Meyer gain scores.24 We found no patients, our stimulation protocol (12 sessions with 30 minutes
significant differences between functional improvements of the of stimulation time) does not induce superior improvements
intervention and the control group. However, there were compared to the same amount of conventional upper extremity
clinically important group differences of median EBI subscore motor training. We assume that within normal rehabilitation
and CMSA arm score, both favoring the control group. In other conditions in our country, it would be necessary for people to
studies of comparable participants, group differences for similar continue FES themselves at home. This would probably require
functional tests were inconsistent. The lack of significant group a simpler stimulation protocol. Based on our findings, further
differences in our study might not only be because of a small studies have to be carried out in at least 50 participants
group size, but also because of the low number of FES sessions. randomized to FES and conventional therapy, and additional
In other studies on acute stroke patients, various frequencies of dose-response studies with our protocol are necessary to identify
stimulation sessions were applied, from 24 to 120 sessions.8,10,24,25 the required minimum number of FES training sessions.
Furthermore, 25% of our participants had only 7 or less
stimulation sessions, reducing the potential effect of FES. The Acknowledgments
donning and doffing of the system reduced the effective time for
exercises in the FES group, suggesting that control participants The authors thank the physicians of the Reha Rheinfelden
had clinically important, though not significantly higher gains of in Switzerland for assessing subjects for eligibility; the
the EBI subscore and CMSA arm score. Baseline differences occupational therapists, physiotherapists, and nursery staff for
might also be responsible for these results. The proportion of thoroughly carrying out the treatment and assessment; and all
participants with hemineglect was higher in the FES group, patients for their participation in the study. This work was
reducing the motor recovery potential.26 The dominant hand supported in part by the National Center of Competence
was more frequently affected in the control group. Because of NCCR: Plasticity and Repair.
higher motor awareness of the dominant hand,27 the dominant
side possibly had the potential for greater improvement. References
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