Session Information
Date: Thursday, November 14, 2019
Session Title: Neurological Rehabilitation Research Report
Session Time: 12:30pm-2:00pm
Location: Research Hub - Kiosk 6
Disclosures: Jean-Michel Gracies: Allergan: Consultant/Advisory Board, Research Grant or Support
Ipsen: Consultant/Advisory Board, Research Grant or Support, Research Grant includes principal investigator, collaborator or consultant and pending grants as well as grants already received
Merz: Consultant/Advisory Board, Research Grant or Support
Objective: To report baseline data from ENGAGE, an international phase 3b/4, prospective, single-arm, open-label study (NCT02969356).
Design: ENGAGE assessed effects of Guided Self-rehabilitation Contracts (GSC) combined with co-injection of abobotulinumtoxinA (aboBoNT-A) into the upper (UL) and lower limbs (LL) on active movements in patients with spasticity.
Setting: Multiple sites in France, the Czech Republic, Russia and the USA.
Participants: Adults with chronic hemiparesis resulting from acquired brain injury, stratified with UL or LL as primary treatment target (PTT).
Interventions: Patients received personalized GSC with 2 consecutive injections of aboBoNT-A 1500 U across PTT and non-PTT limbs.
Main Outcome Measures: Primary efficacy endpoint was the proportion of responders in the PTT (improvement in composite active range of motion [CXA] of ≥35 or 5 in UL or LL, respectively) at Cycle 2 Week 6.
Results: Of 160 patients enrolled, 157 were included in the safety population, 153 in the intention-to-treat (ITT) population and 136 in the modified ITT population. 91% of patients had experienced stroke, and median time since brain injury was 4.5 years. The proportion of patients split by PTT was 52% versus 48% for UL and LL, respectively. 74% of patients were GSC-naïve and 27% were naïve to botulinum toxin (BoNT) for both UL and LL spasticity (34% UL-naïve; 58% LL-naïve). Median baseline aboBoNT-A doses administered were 1000 U in PTT, regardless of whether the PTT was UL or LL. Mean (SD) CXA at baseline was 317.9 (115.3) in UL and 141.3 (31.5) in LL. Baseline CXA was variable between countries: CXA was higher in the LL of patients from Czech Republic and lower in those from Russia, and higher in the UL of patients from USA.
Conclusions: The ENGAGE study will provide insights into the safety and efficacy of the combination of GSC with aboBoNT-A, simultaneously injected into UL and LL, in adults with spastic hemiparesis.
Level of Evidence: Level II
To cite this abstract in AMA style:
Gracies J, Francisco GE, Khatkova S, Jech R, Maisonobe P, Rios C. Guided Self-rehabilitation Contracts Combined with Simultaneous Injections of Abobotulinumtoxina into Upper and Lower Limbs in Spastic Hemiparesis: Baseline Data from the ENGAGE Study [abstract]. PM R. 2019; 11(S2)(suppl 2). https://pmrjabstracts.org/abstract/guided-self-rehabilitation-contracts-combined-with-simultaneous-injections-of-abobotulinumtoxina-into-upper-and-lower-limbs-in-spastic-hemiparesis-baseline-data-from-the-engage-study/. Accessed May 12, 2025.« Back to AAPM&R Annual Assembly 2019
PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/guided-self-rehabilitation-contracts-combined-with-simultaneous-injections-of-abobotulinumtoxina-into-upper-and-lower-limbs-in-spastic-hemiparesis-baseline-data-from-the-engage-study/