Open Access Highly Accessed Study protocol

Upper limb children action-observation training (UP-CAT): a randomised controlled trial in Hemiplegic Cerebral Palsy

Giuseppina Sgandurra12, Adriano Ferrari34, Giuseppe Cossu5, Andrea Guzzetta2, Laura Biagi2, Michela Tosetti2, Leonardo Fogassi5 and Giovanni Cioni26*

Author Affiliations

1 Scuola Superiore Sant'Anna, Piazza Martiri della Libertà, 33 - 56127 Pisa, Italy

2 Department of Developmental Neuroscience, Fondazione IRCCS Stella Maris, Viale Del Tirreno, 331, 56128, Calambrone (Pisa), Italy

3 Children Rehabilitation Unit, S.Maria Nuova Hospital, Viale Risorgimento, 80, 42123 Reggio Emilia, Italy

4 Department of Neuroscience, University of Modena and Reggio Emilia, via Pietro Giardini, 1355 - loc. Baggiovara, 41126 Modena, Italy

5 Department of Neuroscience, Section of Physiology, University of Parma, Via Volturno, 39 - 43125 Parma, Italy

6 Division of Child Neurology and Psychiatry, University of Pisa, Via dei Giacinti, 2, 56128 Pisa, Italy

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BMC Neurology 2011, 11:80  doi:10.1186/1471-2377-11-80

Published: 28 June 2011

Abstract

Background

Rehabilitation for children with hemiplegic cerebral palsy (HCP) aimed to improve function of the impaired upper limb (UL) uses a wide range of intervention programs. A new rehabilitative approach, called Action-Observation Therapy, based on the recent discovery of mirror neurons, has been used in adult stroke but not in children. The purpose of the present study is to design a randomised controlled trial (RCT) for evaluating the efficacy of Action-Observation Therapy in improving UL activity in children with HCP.

Methods/Design

The trial is designed according to CONSORT Statement. It is a randomised, evaluator-blinded, match-pair group trial. Children with HCP will be randomised within pairs to either experimental or control group. The experimental group will perform an Action-Observation Therapy, called UP-CAT (Upper Limb-Children Action-Observation Training) in which they will watch video sequences showing goal-directed actions, chosen according to children UL functional level, combined with motor training with their hemiplegic UL. The control group will perform the same tailored actions after watching computer games. A careful revision of psychometric properties of UL outcome measures for children with hemiplegia was performed. Assisting Hand Assessment was chosen as primary measure and, based on its calculation power, a sample size of 12 matched pairs was established. Moreover, Melbourne and ABILHAND-Kids were included as secondary measures. The time line of assessments will be T0 (in the week preceding the onset of the treatment), T1 and T2 (in the week after the end of the treatment and 8 weeks later, respectively). A further assessment will be performed at T3 (24 weeks after T1), to evaluate the retention of effects. In a subgroup of children enrolled in both groups functional Magnetic Resonance Imaging, exploring the mirror system and sensory-motor function, will be performed at T0, T1 and T2.

Discussion

The paper aims to describe the methodology of a RCT for evaluating the efficacy of Action-Observation Therapy in improving UL activity in children with hemiplegia. This study will be the first to test this new type of treatment in childhood. The paper presents the theoretical background, study hypotheses, outcome measures and trial methodology.

Trial Registration

NCT01016496