Upper limb children action-observation training (UP-CAT) study: design of a randomised clinical trial for children with hemiplegia

Objective: The purpose of the present study was to design and test a Randomised Clinical Trial (RCT) for evaluating the efficacy of action-observation therapy in improving the upper limb (UL) activity in children with hemiplegia. Background: Rehabilitation for children with hemiplegia to improve function in the impaired UL uses a wide range of intervention programs; researches using adequately powered RCTs, rigorous methodology and valid outcome measures are essential, to provide the highest level support of therapy effectiveness. Design/Methods: The trial was designed according to Consolidated Standards of Reporting Trials (CONSORT) Statement. It was a randomised, evaluator-blinded, matchpair group trial. Children were randomised within pairs to either experimental or control group. The experimental group performed an Action–Observation Therapy based on watching video sequences of goal actions, chosen according to their UL functional level, combined with motor training with their hemiplegic UL. The control group performed the same tailored actions after watching computer games. A carefully revision of psychometric properties (e.g. small detectable differences) of UL outcome measures for hemiplegic children was performed. Assisting Hand Assessment was chosen as primary measure and based on its power calculation a sample size of 12 matched pairs was established. Moreover, Melbourne and ABILHAND-Kids were included as secondary measures. The time line of assessments was T0 (on the week preceding the onset of the treatment), T1 and T2 (on the week and 8 weeks after the end of the treatment, respectively). Results: We were able to perform children recruitment and testing in the 24 consecutive children according to above experimental planning. The two experimental and control groups differ only for the type of observation but the performed actions were similar so that the changes induced by observation should be measured. Conclusions: To provide reliable results of program rehabilitation effectiveness it is essential to design RCT studies according to CONSORT guidelines.