title: A randomized trial of upper limb botulimun toxin versus placebo injection, combined with physiotherapy, in children with hemiplegia.
abstract: The main goal of this study was to investigate the efficacy of Botulinum Toxin A (BoNT-A), combined with an individualized intensive physiotherapy/orthoses treatment, in improving upper limb activity and competence in daily activity in children with hemiplegia, and to compare its effectiveness with that of non-pharmacological instruments. It was a Randomized Clinical Trial of 27 children with spastic hemiplegic cerebral palsy, outpatients of two high speciality Centres for child rehabilitation. Each child was assigned by simple randomization to experimental group (BoNT-A) or control group (placebo). Assisting Hand Assessment (AHA) was chosen as primary outcome measure; other measures were selected according to ICF dimensions. Participants were assessed at baseline (T0), at T1, T2, T3 (1-3-6 months after injection, respectively). Every patient was given a specific physiotherapeutic treatment, consisting of individualized goal directed exercises, task oriented activities, daily stretching manoeuvres, functional and/or static orthoses. BoNT-A group showed a significant increase of AHA raw scores at T2, compared to control group (T2-T0: p=.025) and functional goals achievement (GAS) was also slightly better in the same group (p=.033). Other measures indicated some improvement in both groups, without significant intergroup differences. Children with intermediate severity of hand function at House scale for upper limb impairment seem to have a better benefit from BoNT-A protocol. BoNT-A was effective in improving manipulation in the activity domain, in association with individualized goal-directed physiotherapy and orthoses; the combined treatment is recommended. The study brings more evidence for the efficacy of a combined treatment botulinum toxin injection-physiotherapy-orthoses, and it gives some suggestions for candidate selection and individualized treatment.
authors.affiliation: Department of Biomedical, Metabolic Sciences and Neuroscience, University of Modena and Reggio Emilia, 42123 Reggio Emilia, Italy; Children Rehabilitation Unit, IRCCS S. Maria Nuova Hospital, 42123 Reggio Emilia, Italy. Electronic address: ferrari.adriano@asmn.re.it.
authors.forename: Adriano
authors.initials: A
authors.lastname: Ferrari
authors.affiliation: Children Rehabilitation Unit, IRCCS S. Maria Nuova Hospital, 42123 Reggio Emilia, Italy. Electronic address: maoret.annarosa@asmn.re.it.
authors.forename: Anna Rosa
authors.initials: AR
authors.lastname: Maoret
authors.affiliation: Children Rehabilitation Unit, IRCCS S. Maria Nuova Hospital, 42123 Reggio Emilia, Italy. Electronic address: muzzini.simonetta@asmn.re.it.
authors.forename: Simonetta
authors.initials: S
authors.lastname: Muzzini
authors.affiliation: Children Rehabilitation Unit, IRCCS S. Maria Nuova Hospital, 42123 Reggio Emilia, Italy. Electronic address: alboresi.silvia@asmn.re.it.
authors.forename: Silvia
authors.initials: S
authors.lastname: Alboresi
authors.affiliation: Intensive Rehabilitation Unit, S. Sebastiano Hospital, 42015 Correggio (Reggio Emilia), Italy. Electronic address: francesco.lombardi@auls.re.it.
authors.forename: Francesco
authors.initials: F
authors.lastname: Lombardi
authors.affiliation: Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris, 56128 Calambrone (Pisa), Italy. Electronic address: g.sgandurra@fsm.unipi.it.
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Sgandurra
authors.affiliation: Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris, 56128 Calambrone (Pisa), Italy. Electronic address: pb.paolicelli@fsm.unipi.it.
authors.forename: Paola Bruna
authors.initials: PB
authors.lastname: Paolicelli
authors.affiliation: Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris, 56128 Calambrone (Pisa), Italy. Electronic address: e.sicola@fsm.unipi.it.
authors.forename: Elisa
authors.initials: E
authors.lastname: Sicola
authors.affiliation: Department of Developmental Neuroscience, IRCCS Fondazione Stella Maris, 56128 Calambrone (Pisa), Italy; Department of Clinical and Experimental Medicine, University of Pisa, 56126 Pisa, Italy. Electronic address: g.cioni@fsm.unipi.it.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Cioni
mesh_terms: D019274:Botulinum Toxins, Type A / Q000627:therapeutic use*; D002547:Cerebral Palsy / Q000150:complications / Q000534:rehabilitation*; D002648:Child; D002675:Child, Preschool; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D006429:Hemiplegia / Q000150:complications / Q000534:rehabilitation*; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D009128:Muscle Spasticity / Q000209:etiology / Q000534:rehabilitation*; D009465:Neuromuscular Agents / Q000627:therapeutic use*; D009989:Orthotic Devices; D026741:Physical Therapy Modalities; D016896:Treatment Outcome; D034941:Upper Extremity
chemical_list: D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A
keywords: Botulinum toxin type A; Child hemiplegia; Orthoses; Physiotherapy; Upper limb