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TABLE I
SUBJECT DEMOGRAPHICS
# of previous UE
Impaired Age Months Baseline Baseline
Gender Handedness intervention
side (years) Post CMSA-H FMUE
studies
XS01 F R
R 53 5.1 0 3
19
XS02 M R
R 43 5.5 0 3
14
XS03 M R
R 53 5.8 0 3
9
XS04 M R
R 55 5.3 0 3
12
XS05 F L
R 51 2.0 1 3
17
XS06 F R
L 59 3.6 2 3
25
XS07 M R
L 58 2.8 1 3
19
XS08 M L
L 75 3.9 0 3
17
XS09
M
R
R
74
4.7
0
3
23
XS10
M
R
L
84
2.3
0
3
20
XS11
M
R
L
78
3.6
0
4
17
XS12
M
L
L
65
3.5
1
3
11
XS13
M
L
R
71
4.1
0
3
8
3F/10M
9R/4L
7R/6L
63
12
4
1
30.3
165
CMSA-H: Chedoke McMaster Stroke Assessment Stage of Hand Score, UE: upper extremity, L: left, R: right, FMUE: Fugl-
Meyer Assessment for the upper extremity.
Immediately afterward, participants employed the X-Glove therapy (Post); and 1 month after completion of therapy
for 60 minutes of active training guided by a research (Follow-up). As we were interested both in measures of task
occupational therapist using a task-oriented protocol. In this performance with the upper extremity and in evaluations of
therapy protocol (see Appendix), developed at the impairment, we used a set of outcome measures. Clinical task
Rehabilitation Institute of Chicago by Dr. Mary Ellen performance was evaluated with the Action Research Arm
Stoykov, participants were encouraged to perform high Test (ARAT) [34], the Graded Wolf Motor Function Test
repetitions of tasks, task components, and performance skills (GWMFT) [35] and the Chedoke Arm and Hand Inventory
focused mainly on the hand. As part of the protocol, the (CAHAI-9) [36]. Impairment was evaluated with the Fugl-
Canadian Occupational Performance Measure (COPM) [33] Meyer Assessment for Motor Recovery after Stroke for the
was administered to identify goals that incorporated use of the Upper Extremity (FMUE) [37] and hand strength assessments.
affected hand. Part of each training session was used to For the latter, the 3-point palmar (PPS) and lateral pinch
practice these tasks, while the remainder was used to practice strengths (LPS) were measured with a pinch gauge (PG-60,
component skills. The occupational therapist provided B&L Engineering), grip strength (GS) was quantified with a
feedback to the client regarding performance and graded tasks dynamometer (JAMAR 5030J1 Hand Dynamometer), and
as well as the environment as needed to optimize challenge. finger extension force (EXT) was recorded with a digital force
The therapist recorded total repetitions completed during each gauge (Mark-10 Corp. MG200).
session. Additional outcome measures were included to further
examine effects of the treatment. They consisted of the
Modified Modified Ashworth Scale (MMAS) [38, 39] and the
Motor Activity Log (MAL) [40]. The MAL was administered
once prior to treatment, immediately following treatment, and
one-month later. A single research therapist, uninvolved with
the participants training, completed all of the assessments for
each stroke survivor.
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SPSS software (IBM SPSS Advanced Statistics; IBM Corp) to once prior to treatment (Pre), immediately following treatment
determine whether the combination of passive cyclical (Post), and one-month later (Follow-up)-treatment. The
stretching with active-assist therapy impacted the outcome Quality of Movement (QOM) portion of the MAL was used
variables. Specifically, the impact of the within-subject factor exclusively in data analysis as it has been found to be a
Evaluation (4 levels: Pre, Mid, Post, Follow-up) on the reliable measure of real-world arm use [40]. A rm-MANOVA
outcome measures was examined. Post hoc univariate analyses was performed with subsequent post hoc univariate ANOVAs
of variance (ANOVAs) were performed separately on each for outcomes showing a significant effect of evaluation. Post-
dependent variable (outcome) for the independent factor found hoc pairwise comparisons with a Bonferroni correction for
to have a significant effect, as determined by a Wilks lambda multiple comparisons were conducted to further evaluate the
p-value<0.05. Post hoc pairwise comparisons with a impact across the evaluations.
Bonferroni correction for multiple comparisons were
conducted to further evaluate the impact across the III. RESULTS
evaluations. A total of 13 stroke survivors completed the 15 training
As participants were in the subacute phase of recovery, sessions and all 6 evaluation sessions. Two participants
linear regression analyses were subsequently performed to withdrew before completion of the studyone due to personal
compare the rates of change of the outcome measures from scheduling conflicts and one due to pain in the digits and
before treatment initiation to those during the treatment phase. decreased activity tolerance while wearing the X-Glove during
To be able to look across all subjects, the regression models the active training mode. Participants ranged in age from 43-
were fit to the change in outcomes for the second and third 84 years. All but one participant had hand impairment rated as
evaluations, Pre-2 and Pre-3, relative to the first evaluation Stage of Hand 3 on the CMSA-H; this individual had Stage of
(Pre-1) and for change for the Mid- and Post-evaluations Hand 4 (see Table I).
relative to Pre-3. Thus, the regression models were forced to Despite the substantial motor impairment (mean FMUE =
pass through the origin. An indicator variable was included in 16.2), participants were able to use the X-glove to complete a
the regression model to directly compare the slopes from significant number of therapeutic movements. Participants
before and during treatment. Finally, the Follow-Up outcome were able to complete an average of 163(44) movement
values were compared with those estimated from the repetitions per training session.
regression models for the pre-training data. Participants exhibited improvement during the treatment,
For the additional outcome measures, a summation of with retention up to one-month later (for an example, see Fig.
scores for wrist extension, wrist flexion, finger extension and 3). Across subjects, the data for the outcome measures met the
finger flexion was calculated using the MMAS scale (0-5) for normality assumption (Shapiro Wilk: p>0.01), so rm-
each of the 6 evaluation sessions. The MAL was administered MANOVA was performed. A significant effect of Evaluation
TABLE II
MEAN OUTCOME MEASURES SCORE (SD) AT EACH EVALUATION SESSION
Outcome Measure Max Pre1 Pre2 Pre3 Mid Post Follow-up P-value
Score
Clinical Task
Performance
ARAT 57 9.9(7.0) 10.1(6.1) 10.5(6.2) 12.9(7.9) 12.4(7.9) 13.9(8.4) .020
CAHAI-9 7 1.7(1.0) 1.7(0.8) 1.8(0.8) 2.0(0.8) 2.4(1.0) 2.2(0.9) <.001
GWMFT-func 5 2.6(1.2) 2.5(1.1) 2.7(1.1) 2.9(1.2) 3.1(1.3) 3.3(1.4) .029
GWMFT-time (s) 120 69.4(31.4) 72.2(29.4) 68.3(29.4) 60.5(30.8) 56.2(30.7) 60.6(29.6) .001
Upper Extremity
Impairment
EXT (N) -- 6.0(6.2) 6.4(6.9) 6.3(6.4) 7.6(8.4) 7.5(8.2) 7.1(7.6) .590
FMUE 66 16.2(5.2) 16.2(4.9) 17.0(6.1) 18.9(4.9) 19.2(5.8) 20.1(5.3) <.001
GS(N) -- 47.6(33.7) 45.3(36.7) 52.0(33.7) 58.2(38.0) 67.3(41.6) 70.2(32.1) <.001
LPS (N) -- 21.4(17.3) 22.4(20.5) 21.9(13.3) 28.2(16.3) 32.3(20.7) 30.8(18.0) .003
PPS (N) -- 16.1(9.4) 16.3(10.9) 15.6(7.3) 20.4(11.5) 21.1(9.3) 20.2(10.9) .008
Spasticity &
Function
MMAS 20 4.0(2.2) 4.5(2.1) 4.0(2.2) 3.9(3.0) 3.8(2.9) 3.5(2.9) .280
MAL QOM 5 -- -- 0.6(0.5) -- 1.2(0.9) 1.5(1.2) .001
ARAT: Action Research Arm Test; CAHAI-9: Chedoke Arm and Hand Inventory; GWMFT-func: Graded Wolf Motor
Function Test (functional score); GWMFT-time: Graded Wolf Motor Function Test (completion time); EXT: finger extension
force; FMUE: Fugl-Meyer Assessment for the upper extremity; GS: grip strength; LPS: lateral pinch strength; PPS: palmar
pinch strength; MMAS: Modified Modified Ashworth Scale; MAL QOM: Motor Activity Log (quality of movement). P-
value is Univariate rm-ANOVA.
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Fig. 3. Select outcome measures for a single subject across evaluation sessions. (a) Chedoke Arm and Hand Inventory; (b)
Action Research Arm Test; (c) Fugl-Meyer Assesment for Upper Extremity; (d) palmar pinch strength. Trend for
improvement was greater during treatment (shaded box) than during the pre-treatment timeframe.
session was observed (Wilks lambda<0.001). Subsequent exhibited significant goodness-of-fit to the regression model
univariate tests confirmed that this effect was present for all (p<0.01 and R2>0.24). The magnitudes of the slopes for the
outcome measures except isometric finger extension (Table data from the training period were always greater than those
II). Post-hoc pairwise comparisons implementing a Bonferroni for the pre-training data. The regression model revealed
correction confirmed that mid-training scores were significantly greater slopes during training for PPS (p=0.04),
significantly better than the mean pre-training scores for GWMFT-functional (p=0.029), and GWMFT-time (p=0.019),
GWMFT functional (p=0.045) and mean completion time while the LPS approached significance (p=0.059) (Fig. 4).
(p=0.042), GS (p=0.042), LPS (p=0.031), FMUE (p=0.001), Projections of improvement at the one-month follow-up
and ARAT (p=0.014). Post-training scores continued to show evaluation were made from the regression model for the pre-
improvement over the mean pre-training scores for GWMFT treatment data. The extrapolations of these models
functional (p=0.003) and GWMFT mean completion time underestimated the entire 95% confidence intervals for the
(p=0.002), GS (p<0.001), LPS (p=0.020), FMUE (p=0.012) actual Follow-up outcomes for GWMFT-time, GWMFT-
and additionally for PPS (p<0.001) and CAHAI-9 (p=0.008). functional score, GS, and PPS.
At the one-month follow-up, scores were still significantly For the additional outcome measures, the results also
better than mean pre-training values for CAHAI-9 (p=0.028), showed improvement following treatment. The rm-MANOVA
FMUE (p=0.002) and GS (p<0.001). revealed a significant effect of Evaluation session (Wilks
To look at rates of change over time, we performed lambda=0.002). Subsequent univariate rm-ANOVAs showed
regression analyses for the pooled data across subjects for the significant changes for the MAL(QOM) (p=0.001) but not for
pre-training data and the data during training. For the pre- the MMAS (p=0.280). Mean Post-training scores for the
training data, none of the outcome measures had a significant MAL(QOM) increased by 0.590.61 (p=0.14) and Follow-up
fit for the linear regression model (p>0.204 for each scores by 0.950.84 (p=0.004); both varied significantly from
regression) and the R2 values were quite small (less than the pre-training scores. MMAS showed a mean decrease of
0.064). In contrast, for the evaluations covering the treatment 0.461.56 and 0.691.71 for the Post- and Follow-up scores,
phase, all tested outcome measures, except extension strength, respectively.
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Fig. 4. Comparison of the regression models fit to the pre-training data and to the data during the training period. Data were
pooled across subjects. Asterisks denote mean for each evaluation session. Pre-training data (circles) computed as difference
with respect to first evaluation session. Training data (squares) computed as difference with respect to third pre-training
evaluation session. (a) Graded Wolf Motor Function Test time; (b) Graded Wolf Motor Function Test functional score;
(c) grip strength; (d) lateral pinch strength.
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translation of these findings into practice, while the MDC for outpatient rehabilitation settings prior to enrolling in this
the FMUE approached clinical significance at one month [45]. study, the gains achieved suggest an effect of the specific
The mean time to complete each task on the GWMFT dropped treatment we imposed. The positive results provide impetus
by over 13 seconds following training, or 20% of the pre- for a future clinical trial with a matching control group.
training time. Grip strength increased by almost 20 N, or 35% Pre-training data were collected over two weeks prior to
of the largest pre-training value. Palmar and lateral pinch initiation of treatment rather than over a longer period as we
strengths increased by 32% and 48%, respectively, after wished to start training as early as possible to maximize
treatment. The strength gains are important as the participants benefits. While one might argue that this period was too short
exhibited substantial weakness, as we have previously to detect ongoing changes, the Mid-evaluation data were
described in similar populations [12]. collected at 3 weeks after the initiation of treatment, and at
Certainly, some of this improvement may have occurred this point a number of the outcome measures exhibited
even without the intervention, especially as the subjects were significant improvement.
in the subacute phase of recovery. Yet, recent cohort studies While positive outcomes were observed at one-month
aimed at predicting long-term outcomes following stroke following the end of treatment, it is not known if they were
suggest stroke survivors with moderate to severe upper maintained beyond this point. Intriguingly, the rate of
extremity impairment reach a plateau in recovery roughly 3 improvement observed between the Mid and Post sessions was
months following stroke [46-48]. Participants were 4 months typically as great as that seen between the Pre-3 and Mid
post-stroke on average when they began this study. evaluations. This suggests that further improvement might be
Accordingly, our pre-training outcome evaluations showed obtained with more treatment sessions. A future study with a
little change over time. In contrast, the outcome data collected longer treatment period and a longer follow-up period seems
during treatment displayed a significant improvement over warranted.
pre-training data. These gains tended to increase from the
middle to the end of training; thereby suggesting that even
further improvement may have been possible with continued V. CONCLUSION
treatment. It is interesting to note that a number of the one- Our results suggest that use of an actuated device, which
month post-therapy outcomes were greater than those can be incorporated directly into clinical therapy, may be
predicted by the pre-therapy regression models. While these beneficial for facilitating rehabilitation. Stroke survivors with
predictions require extrapolation from the data points used to severe hand impairment may benefit from a combination of
create the models and so may not accurately represent natural passive cyclical stretching and targeted assistance of active
recovery, they do provide an interesting comparison of the movements. This paradigm affords participants and their
actual trajectory with that expected from the pre-training therapists the opportunity to maximize rehabilitation of motor
evaluations. control by providing skilled, task-oriented therapy in the clinic
Given our past results [49], we believe that the stretching that may not otherwise be attempted for stroke survivors with
helps to reduce the long flexor hyperexcitability common in this level of impairment. This seems to be particularly
the targeted population, thereby facilitating the subsequent essential during the subacute phase of recovery [51].
active movement practice. Additionally, having to close the
digits against the extension assistance may actually have APPENDIX
helped to increase strength, as suggested by a study
A detailed description of the task-oriented protocol used in
implementing resistance training in stroke survivors [50]. In
the intervention for this study is available in the online version
accordance with that study, we saw no significant change in
of this manuscript.
spasticity as measured with the MMAS. Thus, the treatment
did not appear to exacerbate hyperexcitability. Extension force
ACKNOWLEDGMENT
was the only strength measurement that did not show
significant improvement. It is possible that more directly The authors would like to thank Molly Corrigan, MS,
targeting the extensors with resistance training would be OTR/L, for her assistance with training sessions and Dr.
beneficial. Catherine Lang, PT, PhD, for her assistance with study design.
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1534-4320 (c) 2015 IEEE. Personal use is permitted, but republication/redistribution requires IEEE permission. See http://www.ieee.org/publications_standards/publications/rights/index.html for more information.
This article has been accepted for publication in a future issue of this journal, but has not been fully edited. Content may change prior to final publication. Citation information: DOI 10.1109/TNSRE.2015.2513675, IEEE
Transactions on Neural Systems and Rehabilitation Engineering
TNSRE-2015-00086.R2 9
shoulder abduction within 72 hours after stroke predicts functional Kelly O. Thielbar received her B.S
recovery: early prediction of functional outcome after stroke: the EPOS degree in Psychology from the University
cohort study," Stroke, vol. 41, pp. 745-50, Apr 2010. of Illinois in Champaign-Urbana in 2006
[47] C. E. Lang, S. L. DeJong, and J. A. Beebe, "Recovery of thumb and
finger extension and its relation to grasp performance after stroke," J
and M.S. degree in occupational therapy
Neurophysiol, vol. 102, pp. 451-9, Jul 2009.
from Washington University in St. Louis
[48] J. A. Beebe and C. E. Lang, "Active range of motion predicts upper in 2010.
extremity function 3 months after stroke," Stroke, vol. 40, pp. 1772-9, From 2010 to the present she has
May 2009. been an Occupational Therapist at the
[49] K. M. Triandafilou, H. C. Fischer, J. D. Towles, D. G. Kamper, and W. RIC. She has had a position as a research
Z. Rymer, "Diminished capacity to modulate motor activation patterns Occupational Therapist in the Coleman Hand Rehabilitation
according to task contributes to thumb deficits following stroke," J Lab since 2011. Her research interests include upper
Neurophysiol, vol. 106, pp. 1644-51, Oct 2011. extremity neurorehabiliation and functional recovery post
[50] C. Patten, E. G. Condliffe, C. A. Dairaghi, and P. S. Lum, "Concurrent stroke.
neuromechanical and functional gains following upper-extremity power
training post-stroke," J Neuroeng Rehabil, vol. 10, p. 1, 2013.
[51] C. Stinear, S. Ackerley, and W. Byblow, "Rehabilitation is initiated Jos M. Ochoa (M87) received the B.S.
early after stroke, but most motor rehabilitation trials are not: a degree in biomedical engineering from
systematic review," Stroke, vol. 44, pp. 2039-45, Jul 2013. Antioquias School of Engineering,
Envigado, Antioquia-Colombia, in 2009
Heidi C. Fischer received a B.S. in and the M.S. degree in mechanical
Psychology at the University of Illinois at engineering from Northwestern
Urbana-Champaign in 1997 and M.S. and University, Evanston, IL, in 2014.
Doctoral degrees in occupational therapy He is currently working as a research
from the University of Illinois at Chicago engineer at the RIC. His research interest
in 2000 and 2015. includes the development and control of robotic prosthesis and
From 2000 to 2004, she was clinical orthosis using biological signals.
occupational therapist at the
Rehabilitation Institute of Chicago (RIC). Emily D.C. Lazzaro received the B.S
In 2003, she was a research occupational degree in mechanical engineering from
therapist in the Hand Rehabilitation Laboratory and the ARM the University of Virginia in
Guide Laboratory at RIC until 2005, when she became Charlottesville, Virginia in 2002 and a
Clinical Research Coordinator for the Hand Rehabilitation Clinical Doctorate in physical therapy
Laboratory and for a research project in the RIC Center for from the University of Miami in Coral
Outcomes Research. From 2009 to 2011, she served as Quality Gables, Florida in 2009.
Consultant for the American Occupational Therapy From 2009 to 2015, she was a physical
Association. In 2014, she became Clinical Assistant Professor therapist and clinical research coordinator
in Occupational Therapy at the University of Illinois at in the RIC. Her research interests include devices to improve
Chicago. She is co-author of 20 articles, and presented at 15 patient outcomes and safety for patients and therapists in the
national and international conferences. Her research interests clinical environment. She now works as a Clinical Specialist
include improving self-advocacy and participation following with Bioness.
stroke through occupational therapy self-management
interventions, the use of technology and task-oriented Kathleen A. Pacholski received the B.A.
occupational therapy to promote upper extremity function degree in English at Thomas More
following stroke. College in Crestview Hills, Kentucky in
Dr. Fischer was a University Fellow at the University of 1983.
Illinois at Chicago 1997 to 1999, recipient of the Sarah Baskin From 1985 to 1993 she was the
Research Award at RIC in 2008 and is a member of the manager and director of IIT/V, IITs
American Occupational Therapy Association. Interactive Instructional Television
Network. She is currently working as a
Kristen M. Triandafilou (M04) research assistant in the Hand Lab and
received the B.S. and M.S. degrees in the Single Motor Unit (SMU) Lab at the RIC.
electrical engineering from the Illinois
Institute of Technology, in 2004 and Derek G. Kamper (M97) received the
2009, respectively. B.E. degree in electrical engineering from
She is currently working as a Dartmouth College, Hanover, NH, in
biomedical engineer at the RIC. Her 1989, and the M.S. and Ph.D. degrees in
research interest includes the biomedical engineering from The Ohio
development and control of soft robotics
using biological signals for neurorehabilitation, mechatronics, State University, Columbus, OH, in 1992
and upper extremity neuromechanics. and 1997, respectively.
Ms. Triandafilou was recipient of the Achievement He then completed a postdoctoral
Rewards for College Scientists (ARCS) fellowship in 2008 fellowship at the Rehabilitation Institute
and 2009, the Illinois Institute of Technology Research of Chicago. He is currently an Associate Professor in the
Scholarship (IITRS) from the Armor College of Engineering Department of Biomedical Engineering at the Illinois Institute
at IIT in 2005, and Abstract was honored at the American of Technology, Chicago, IL. His research interests include
Society of Biomechanics (ASB) Annual meeting in 2011.
neurorehabilitation, mechatronics, and upper extremity
neuromechanics.
1534-4320 (c) 2015 IEEE. Personal use is permitted, but republication/redistribution requires IEEE permission. See http://www.ieee.org/publications_standards/publications/rights/index.html for more information.