PMID- 34039905
OWN - NLM
STAT- MEDLINE
DCOM- 20210708
LR  - 20230822
IS  - 1557-0584 (Electronic)
IS  - 1557-0576 (Print)
IS  - 1557-0576 (Linking)
VI  - 45
IP  - 3
DP  - 2021 Jul 1
TI  - Guided Self-rehabilitation Contracts Combined With AbobotulinumtoxinA in Adults 
      With Spastic Paresis.
PG  - 203-213
LID - 10.1097/NPT.0000000000000359 [doi]
AB  - BACKGROUND AND PURPOSE: Guided self-rehabilitation contracts (GSCs) are a 
      diary-based rehabilitation strategy, wherein specific muscles are identified for 
      prescription of high-load, home self-stretching techniques. We assessed the 
      effect of GSCs combined with simultaneous upper limb (UL) and lower limb (LL) 
      abobotulinumtoxinA injections on composite active range of motion (CXA) in adults 
      with chronic spastic paresis. METHODS: This was an international, prospective, 
      single-arm, open-label study (ENGAGE, NCT02969356). Personalized GSCs were 
      monitored by phone every other week, alongside 2 consecutive abobotulinumtoxinA 
      injections (1500 U) across UL and LL, over 6 to 9 months. Primary outcomes were 
      responder rates (CXA improvement >/=35 degrees  [UL] or >/=5 degrees  [LL]) at week 6 cycle 2. 
      Secondary outcomes were active function (UL: Modified Frenchay Scale [MFS]; LL: 
      10-m barefoot maximal walking speed [WS]) and quality of life (12-item Short Form 
      Health Survey, SF-12). RESULTS: Of the 153 treated participants, 136 had primary 
      endpoint data; 72.1% (95% confidence interval [CI], 64.0-78.9) were responders. 
      Mean (SD) CXA changes from baseline to last study visit were +49.3 degrees  (63.4) for UL 
      and +20.1 degrees  (27.6) for LL. Mean (95% CI) changes from baseline to week 12 cycle 2 
      were +0.55 (0.43-0.66) in MFS, +0.12 m/s (0.09-0.15) for WS, and +4.0 (2.8-5.2) 
      for SF-12 physical scores. In the safety population (n = 157), 49.7% of 
      participants reported treatment-emergent adverse events (AEs); 12.1% reported 25 
      serious AEs. DISCUSSION AND CONCLUSIONS: GSC combined with simultaneous UL and LL 
      abobotulinumtoxinA injections led to improvements in CXA and function in both 
      limbs, and quality-of-life physical scores. These results suggest the beneficial 
      effect of combined GSC and abobotulinumtoxinA therapy in the management of 
      spastic paresis.Video Abstract available for more insight from the authors (see 
      the Supplementary Video, available at: http://links.lww.com/JNPT/A346).
CI  - Copyright (c) 2021 The Authors. Published by Wolters Kluwer Health, Inc.
FAU - Gracies, Jean-Michel
AU  - Gracies JM
AD  - UR 7377 BIOTN, Universite Paris-Est Creteil, Albert Chenevier-Henri Mondor 
      Hospital, Department of Neurorehabilitation, Creteil, France (J.M.G.); Department 
      of Physical Medicine and Rehabilitation, the University of Texas Health Science 
      Center at Houston McGovern Medical School, and the Neurorecovery Research Center 
      at TIRR Memorial Hermann, Houston, Texas (G.E.F.); Department of Neurology, First 
      Faculty of Medicine, Charles University, and General Faculty Hospital, Prague, 
      Czech Republic (R.J.); Neurology Department, Federal State Hospital, Treatments 
      and Rehabilitation, Center of Ministry of Health and Social Development of 
      Russian Federation, Moscow, Russia (S.K.); and Ipsen Pharma, Boulogne- 
      Billancourt, France (C.D.R., P.M).
FAU - Francisco, Gerard E
AU  - Francisco GE
FAU - Jech, Robert
AU  - Jech R
FAU - Khatkova, Svetlana
AU  - Khatkova S
FAU - Rios, Carl D
AU  - Rios CD
FAU - Maisonobe, Pascal
AU  - Maisonobe P
CN  - ENGAGE Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT02969356
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Video-Audio Media
PL  - United States
TA  - J Neurol Phys Ther
JT  - Journal of neurologic physical therapy : JNPT
JID - 101193365
RN  - EC 3.4.24.69 (Botulinum Toxins, Type A)
RN  - EC 3.4.24.69 (abobotulinumtoxinA)
SB  - IM
MH  - Adult
MH  - Botulinum Toxins, Type A
MH  - Humans
MH  - *Muscle Spasticity/drug therapy
MH  - Paresis
MH  - Prospective Studies
MH  - *Quality of Life
MH  - Treatment Outcome
PMC - PMC8191476
EDAT- 2021/05/28 06:00
MHDA- 2021/07/09 06:00
PMCR- 2021/06/10
CRDT- 2021/05/27 05:54
PHST- 2021/05/28 06:00 [pubmed]
PHST- 2021/07/09 06:00 [medline]
PHST- 2021/05/27 05:54 [entrez]
PHST- 2021/06/10 00:00 [pmc-release]
AID - 01253086-202107000-00002 [pii]
AID - 10.1097/NPT.0000000000000359 [doi]
PST - ppublish
SO  - J Neurol Phys Ther. 2021 Jul 1;45(3):203-213. doi: 10.1097/NPT.0000000000000359.