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 primary outcomes 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 chronic hemiparesis.
Setting: Multiple sites in France, the Czech Republic, Russia and the USA.
Participants: Adults with chronic spastic 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 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, 153 received treatment and were included in the intention-to-treat (ITT) population (mean [SD] age, 52.9 [12.6] years; etiology, 90.8% stroke) and 134 completed the study. Proportion of patients split by PTT was 52.3% versus 47.7% for UL and LL, respectively. In the modified ITT population (n=136), mean (SD) overall compliance to GSC was 92.8% (9.9) and 98 patients (72.1% [95% CI 64.0, 78.9]) achieved the primary efficacy endpoint. A greater responder rate was observed in patients with LL as PTT (83.1% [95% CI 72.0, 90.5]) versus UL as PTT (62.0% [95% CI 50.3, 72.4]). Mean (SD) CXA increased from 141.6° (33.7) at baseline to 162.6° (28.1) at last study visit in LL, and from 318.8° (118.3) to 368.0° (112.8), respectively, in UL. Safety data were in line with the known profile of aboBoNT-A; 78 (49.7%) patients reported treatment-emergent adverse events.
Conclusions: In this single-arm, open-label study in patients with chronic spastic hemiparesis, the combination of GSC with aboBoNT-A simultaneously injected into UL and LL is associated with improvement of CXA.
Level of Evidence: Level II
To cite this abstract in AMA style:Gracies J, Francisco GE, Maisonobe P, Jech R, Khatkova S, Rios C. The Effect of Guided Self-rehabilitation Contracts Combined with Simultaneous Injections of AbobotulinumtoxinA into Upper and Lower Limbs on Voluntary Movements in Adults with Spastic Hemiparesis [abstract]. PM R. 2019; 11(S2)(suppl 2). https://pmrjabstracts.org/abstract/the-effect-of-guided-self-rehabilitation-contracts-combined-with-simultaneous-injections-of-abobotulinumtoxina-into-upper-and-lower-limbs-on-voluntary-movements-in-adults-with-spastic-hemiparesis/. Accessed December 1, 2021.
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PM&R Meeting Abstracts - https://pmrjabstracts.org/abstract/the-effect-of-guided-self-rehabilitation-contracts-combined-with-simultaneous-injections-of-abobotulinumtoxina-into-upper-and-lower-limbs-on-voluntary-movements-in-adults-with-spastic-hemiparesis/