OBJECTIVE: To examine the benefits of high intensity ambulatory rehabilitation programmes over usual care following botulinum toxin A (BoNT-A) for post-stroke spasticity in Australian adults. DESIGN: Prospective single centre, controlled clinical trial. PARTICIPANTS: Fifty-nine adults, median 61 years old and 2.5 years following stroke. METHODS: PARTICIPANTS were dichotomised into high intensity ambulatory rehabilitation programmes (≥ 3 × 1-h weekly sessions for approximately 10 weeks) orusual care programmes (≤ 2 × 1-h weekly sessions) following BoNT-A injections for spasticity. A blinded assessor completed outcomes at 0 (baseline), 6, 12 and 24 weeks. Primary endpoints: proportion of participants achieving ≥ 50% of their goals (using Goal Attainment Scaling: GAS) and GAS T-score change at 12 weeks. SECONDARY OUTCOMES: Modified Ashworth Scale (MAS), participant satisfaction, activity/participation measures and caregiver burden. RESULTS: Both groups showed significant improvement in goal attainment and participant satisfaction up to 24 weeks, with no overall between-group significant differences. There was, however, a statistical trend (p = 0.052) for participants to achieve more upper limb goals in the high intensity therapy group. GAS and satisfaction benefits persisted beyond the duration of spasticity reduction as measured by MAS. CONCLUSIONS: While patient-centred outcomes following BoNT-A injections for post-stroke spasticity were not influenced by intensity of ambulatory rehabilitation programmes, there was a trend for high intensity therapy to be associated with greater upper limb goal attainment. This suggests that the effects of more intensive therapy may be a modifier of the 'black box' of rehabilitation; however, further research is required to evaluate this effect and determine which elements of therapy programmes optimise post-BoNT-A outcomes.
RCT Entities:
OBJECTIVE: To examine the benefits of high intensity ambulatory rehabilitation programmes over usual care following botulinum toxin A (BoNT-A) for post-stroke spasticity in Australian adults. DESIGN: Prospective single centre, controlled clinical trial. PARTICIPANTS: Fifty-nine adults, median 61 years old and 2.5 years following stroke. METHODS:PARTICIPANTS were dichotomised into high intensity ambulatory rehabilitation programmes (≥ 3 × 1-h weekly sessions for approximately 10 weeks) or usual care programmes (≤ 2 × 1-h weekly sessions) following BoNT-A injections for spasticity. A blinded assessor completed outcomes at 0 (baseline), 6, 12 and 24 weeks. Primary endpoints: proportion of participants achieving ≥ 50% of their goals (using Goal Attainment Scaling: GAS) and GAS T-score change at 12 weeks. SECONDARY OUTCOMES: Modified Ashworth Scale (MAS), participant satisfaction, activity/participation measures and caregiver burden. RESULTS: Both groups showed significant improvement in goal attainment and participant satisfaction up to 24 weeks, with no overall between-group significant differences. There was, however, a statistical trend (p = 0.052) for participants to achieve more upper limb goals in the high intensity therapy group. GAS and satisfaction benefits persisted beyond the duration of spasticity reduction as measured by MAS. CONCLUSIONS: While patient-centred outcomes following BoNT-A injections for post-stroke spasticity were not influenced by intensity of ambulatory rehabilitation programmes, there was a trend for high intensity therapy to be associated with greater upper limb goal attainment. This suggests that the effects of more intensive therapy may be a modifier of the 'black box' of rehabilitation; however, further research is required to evaluate this effect and determine which elements of therapy programmes optimise post-BoNT-A outcomes.
Authors: Charlotte M W Gaasterland; Marijke C Jansen-van der Weide; Stephanie S Weinreich; Johanna H van der Lee Journal: BMC Med Res Methodol Date: 2016-08-17 Impact factor: 4.615
Authors: Celine Bonnyaud; Philippe Gallien; Pierre Decavel; Philippe Marque; Claire Aymard; Frédéric Pellas; Marie-Eve Isner; François Constant Boyer; François Muller; Jean-Christophe Daviet; Patrick Dehail; Brigitte Perrouin-Verbe; Nicolas Bayle; Emmanuel Coudeyre; Dominic Perennou; Isabelle Laffont; Jacques Ropers; Nabila-Yasmine Domingo-Saidji; Djamel Bensmail; Nicolas Roche Journal: BMJ Open Date: 2018-08-30 Impact factor: 2.692
Authors: Harald Hefter; Werner Nickels; Dietmar Rosenthal; Sara Samadzadeh; Philipp Albrecht Journal: Toxins (Basel) Date: 2021-07-02 Impact factor: 4.546