Impact of abobotulinumtoxinA treatment on the assisting hand assessment in children with hemiparesis due to cerebral palsy: Results from an international, Phase 3, pivotal study (abstract)

Date
2021
Authors
Shierk, A.
Pyrzanowska, W.
Bonikowski, M.
Regnault, B.
Page, S.
Delgado, M.
Journal Title
Journal ISSN
Volume Title
Publisher
The International Society of Physical and Rehabilitation Medicine
Abstract

Background and Aims: When used in conjunction with occupational therapy, the aim of botulinum toxin treatment in children with upper-limb spasticity is to produce a selective reduction in muscle spasticity while optimising the effects of therapies used for improving range of motion, enhancing motor ability and functional skills. We assessed effect of a single abobotulinumtoxinA injection cycle on bimanual performance in children with hemiparesis due to cerebral palsy (CP).


Methods: This was a double-blind, repeat-treatment (<=4 cycles over 1 year) study (NCT02106351). During Cycle 1, children (2-17 years) with CP and spasticity in >=1 upper-limb were randomized to injections of abobotulinumtoxinA 2U/kg (low-dose), 8U/kg and 16U/kg into the primary target muscle group (PTMG; elbow or wrist flexors). All children participated in an individualized home-exercise therapy program. For the subset of children with hemiparesis treated at certified centers, the Assisting Hand Assessment (AHA) was performed at Baseline and Week 6.


Results: Overall 212 children were enrolled, of which 160 had hemiparesis and 92 had AHA assessments at baseline. Mean±SD baseline AHA scores (2U/kg, 8U/kg, 16U/kg) were 43.8±20.5, 46.2±16.7 and 49.3±17.1, respectively. Adjusted mean±SE [95%CI] changes in the AHA scores from baseline to Week 6 of Cycle 1 (n=83) were 4.6±1.8 [1.0, 8.2], 4.8±1.6 [1.6, 8.0] and 3.7±1.6 [0.4, 6.9], respectively. There were no significant differences between higher doses and the 2U/kg low-dose.


Conclusions: By Week 6 post-treatment, abobotulinumtoxinA combined with an individualized home-exercise therapy program provided some improvement in bimanual performance in children with hemiparesis due to CP.

Description
Abstract originally published in Journal of International Society of Physical and Rehabilitation Medicine, 4(S1). English. Published online 2021. https://www.jisprm.org/text.asp?2021/4/5/11/330163
Keywords
Botulinum toxin treatment, Home-exercise therapy program, Double-blind repeat-treatment
Citation
This is the published version of an abstract that is available at https://www.jisprm.org/text.asp?2021/4/5/11/330163. Recommended citation: Shierk, A., Pyrzanowska, W., Bonikowski, M., Regnault, B., Page, S., & Delgado, M.R. (2021). Impact of abobotulinumtoxinA treatment on the assisting hand assessment in children with hemiparesis due to cerebral palsy: Results from an international, Phase 3, pivotal study (abstract). Journal of International Society of Physical and Rehabilitation Medicine, 4(S1). This item has been deposited in accordance with publisher copyright and licensing terms and with the author’s permission.