Effectiveness of Armeo Spring Robotic Therapy in the Function of the Upper Limb of Children With Unilateral Spastic Cerebral Palsy Infiltrated With Botulinum Toxin

The study will contemplate the description of the clinical characteristics of the patients to intervene (sex, age, locality and Manual Classification of Skills system in children with CP - MACS), and the main results consider the quality upper extremity skills test and the questionnaire of Abilhand-kids. Among the secondary outcomes, the presence of adverse effects and adherence to the intervention will be considered, through the record of attendance at the sessions.In relation to standard operating procedures, no statistical calculation of the sample size will be performed as the entire available population will be covered. All children with spastic unilateral Cerebral Palsy between 4 and 10 years of the year 2018 will be selected at Instituto Teletón in the city of Concepción, Chile. The list of those who have recently been infiltrated with botulinum toxin type A in the upper limb and those who have an indication for admission to treatment will be reviewed. A list will be made with the selected users, assigning the child a number for random selection to a specific study group. The list will be sent to the Subdirección de Investigación - Dirección Médica Nacional of Teletón Chile to maintain the masking.

Participants will be randomly assigned using specialized software to the study group (Armeo) and the control group (conventional therapy) to ensure that each participant has an equal probability of being assigned to either of the two groups. After finishing the Armeo spring group treatment and conventional Occupational Therapy, a post-intervention evaluation will be performed at 3 months and follow-up at 6 months.The data collection will be carried out later, through specific sources: clinical history, interview, evaluation guideline, clinical observation and attendance record. To guarantee the registration procedure, it will be determined that at the end of each evaluation period (initial evaluation, post intervention and follow-up) the evaluator will immediately transfer the information to the database, and it will be verified that it matches the evaluated user through the clinical history number assigned.

The processing and statistical analysis of the data will be coded in an Excel spreadsheet and will be processed using statistical software SPSS v17.0. A normality test will be performed to verify the distribution of the data. According to this result, the corresponding position and dispersion measures will be obtained. To contrast the values of the intragroup variables at the different evaluation times, repeated measures tests will be used and, to evaluate the differences between the study groups, T test or Kruskal Wallis tests will be used, considering a level of significance of 5%. As safety considerations for participants, it is that the treatment will be suspended in the event of the presence of adverse events, for example, skin lesions, pain and fatigue.

Inclusion criteria

• Clinical diagnosis of Unilateral spastic cerebral palsy
• Botulinum toxin infiltration 3 weeks before start
• Manual Ability Classification scale in level I, II and III

Exclusion criteria

• Fixed upper extremity contractures
• Not integrate their affected upper limb into activity.
• Difficult to follow instructions
• Epileptic seizures
• Osteoporosis
• Instability in vital pulmonary or cardiovascular functions