S157 S290
(76%). In bivariate analysis, disposition was associated with initial
NIHSS (P
<
.05) but not age, sex, or race. In multivariate analysis, only
initial NIHSS was associated with disposition.
Conclusions:
Patients with a NIHSS
>
4 are more likely to be discharged
to a rehabilitation facility. Early PM&R consultation for patients with a
NIHSS score
>
4 may enable patients who are candidates for acute
rehabilitation to enter rehabilitation at the most appropriate facility
at the correct timing.
Level of Evidence:
Level III
Poster 62:
Effect on Voluntary Movements of Simultaneous
Upper and Lower Limb AbobotulinumtoxinA
Injections in Conjunction with Guided Self-
Rehabilitation Contracts in Adults with Spastic
Hemiparesis: Methodology of the ENGAGE Study
Jean-Michel Gracies, MD (EA 7377 BIOTN, Universite´ Paris-Est,
Hospital Albert Chenevier-Henri Mondor, Service de Re´e´ducation
Neurolocomotrice, Cre´teil, Cre´teil, France), Gerard E. Francisco, MD,
Robert Jech, MD, Francois Constant Boyer, MD, Pascal Maisonobe, MD,
Jovita Balcaitiene, MD
Disclosures:
Jean-Michel Gracies: Consulting fees or other remuner-
ation (payment) - Merz, Allergan, Ipsen; Research Grants - Allergan,
Ipsen, Merz; Consulting - Merz
Objective:
To assess the effect of abobotulinumtoxinA (aboBoNT-A;
Dysport ) on voluntary movements following a 1500 U total dose in-
jection split between the upper (UL) and lower limb (LL) in conjunc-
tion with Guided Self-rehabilitation Contracts (GSC).
Design:
Phase 3b/4 (dependent on country), prospective, single-arm,
open-label study (NCT02969356).
Setting:
20 centres across Europe and the USA.
Participants:
Planned recruitment of 155 adults with spastic
hemiparesis due to acquired brain injury; stratified so either limb is
the primary treatment target (TT) in 50% of patients ( 10%
flexibility).
Interventions:
Two consecutive injection cycles (12
e
20 weeks apart)
of aboBoNT-A 1500 U, split between the UL and LL. Doses administered
per investigators’ judgement; 750 U required in primary TT for each
cycle. Patients will receive personalised GSC, consisting of prescribed
stretch postures and exercises to be performed daily and recorded in a
diary.
Main Outcome Measures:
The primary efficacy endpoint is the
proportion of responders (improvement in composite active range
of motion of 35 or 5 in UL or LL, respectively), in the primary
TT (finger, wrist and elbow flexors for UL; soleus and gastrocne-
mius muscles for LL) at week 6 of Cycle 2. Secondary efficacy
endpoints include active function in UL (Modified Frenchay Scale)
and LL (walking speed), patient satisfaction with GSC, change in
patients’ and physiotherapists’ beliefs that GSC can help to
improve function, global assessment of benefit by both patients
(caregivers) and physicians, and quality-of-life assessments.
Safety assessment includes recording of adverse events and vital
signs.
Results:
The planned study period is December 2016
e
July 2018. Data
on baseline characteristics and study results are planned to be
disseminated through peer-reviewed journals and at international
congresses.
Conclusions:
The ENGAGE study will provide insights into the safety
and efficacy on voluntary movements of the combination of abobo-
tulinumtoxinA, simultaneously injected into upper and lower limbs,
and GSC in adults with spastic hemiparesis.
Level of Evidence:
Level III
Poster 63:
Dose-Related Response to Ultrasound-Guided Ulnar
In-plane Median Nerve Steroid Injections for Carpal
Tunnel Syndrome
Ian D. Dworkin, MD (UCLA/Greater Los Angeles VA Healthcare System,
Los Angeles, California, United States), G. Sunny Sharma, MD,
Kyle Yang, MD, Gabriel Rudd-Barnard, MD, MS, Lindsay M. Szafranski,
DO, Richard Zhang, MD, Aashna Basu, MD, Dixie R. Aragaki, MD
Disclosures:
Ian Dworkin: I Have No Relevant Financial Relationships
To Disclose
Objective:
To assess the clinical response of two different steroid
doses (20 mg vs. 40 mg triamcinolone acetonide) injected under ul-
trasound (US) guidance with the ulnar in-plane approach in patients
with carpal tunnel syndrome (CTS).
Design:
Prospective, single-blinded, randomized study.
Setting:
Veterans Hospital outpatient PM&R clinic.
Participants:
18 subjects randomly assigned to the 20 mg (n
¼
7) or 40
mg (n
¼
11) groups with electrodiagnostically confirmed CTS.
Interventions:
Patients received either 20 mg or 40 mg triamcinolone
steroid ultrasound-guided injections via the ulnar in-plane approach
into the carpal tunnel.
Main Outcome Measures:
Boston Carpal Tunnel Questionnaire, Ul-
trasound median nerve cross-sectional area measurements at the
distal wrist crease, 4 cm, and 12 cm, proximal and wrist-to-forearm (4
and 12 cm) ratio measurements at baseline versus 1 month follow-up
post injection.
Results:
The initial 18 subjects were randomized to Group one, 20 mg
(n
¼
7) and Group two, 40 mg (n
¼
11). Comparison of Pre and Post CSI
outcomes for both dose groups revealed clinically and statistically
significant symptom (mean
¼
1.15, SD
¼
0.75, p
<
.001) and functional
(mean
¼
0.91, SD
¼
0.99, p
<
.001) improvement as measured by the
BCTQ. Pre and Post CSI WFR did not significantly change (mean
¼
0.46,
SD
¼
1.01, p
¼
.58). There was no statistical difference between pa-
tients who received 20 mg versus 40 mg steroid, and covariates
(gender, age, handedness, side of injection, and unilateral versus
bilateral CTS diagnosis) did not alter our results.
Conclusions:
Currently, there is no standardized dose for carpal
tunnel steroid injections. Due to the potential adverse effects, it is
prudent to clarify the lowest effective dose for treating CTS using a
safe ultrasound-guided technique. Based upon initial analysis, both
the 20 mg and 40 mg dose US-guided CSI with the ulnar in-plane
approach appear efficacious in reducing CTS symptom severity.
Increased sample size through ongoing enrollment will improve the
power to reveal possible differences in ultrasonographic appearance
and subjective responses between the lower and higher steroid doses.
Level of Evidence:
Level II
Poster 64:
AbobotulinumtoxinA Injections in the Upper and
Lower Limb in Patients with Spastic Paresis and
Impaired Function Following Stroke or Traumatic
Brain Injury
Peter McAllister, MD (New England Institute for Neurology and
Headache, Stamford, CT, United States), Svetlana Khatkova, MD,
Steven Faux, MD, Philippe Picaut, Pharm D, PhD, Jovita Balcaitiene,
MD, Romain Raymond, MD, Jean-Michel Gracies, MD
Disclosures:
Peter McAllister: Speakers bureau - Ipsen
Objective:
Management of spastic paresis often requires both upper
limb (UL) and lower limb (LL) treatment. However, limited data are
available investigating simultaneous treatment of both limbs with
botulinum toxin A. This post hoc analysis evaluates walking speed in
S157
Abstracts / PM R 9 (2017) S131-S290