Effectiveness of Armeo Spring Robotic Therapy in the Function of the Upper Limb of Children With Unilateral Spastic Cerebral Palsy Infiltrated With Botulinum Toxin
Condition: Cerebral Palsy; Upper Extremity Paresis
MeSH terms: Paralysis; Cerebral Palsy; Paresis
Study type: Interventional

Summary: 
      Background: Unilateral spastic cerebral palsy (CP) generates an impact on daily activities,
      mainly due to the functional limitation of the affected upper limb. The use of technologies
      such as Armeo spring robotic therapy seeks to improve upper limb mobility through innovative
      and motivating training that facilitates movement.

      Objective: To assess the effectiveness of Armeo spring robotic therapy versus conventional
      occupational therapy regarding the changes in upper limb functionality of children with
      unilateral spastic CP infiltrated simultaneously with botulinum toxin A (BTA).

      Patients and methods: Randomized clinical trial of parallel groups, in children between 4 and
      10 years of age diagnosed with unilateral spastic CP and infiltrates with BTA, who received
      treatment of conventional occupational therapy (group I) or Armeo spring robotic therapy
      (group II). The intervention consists of 15 sessions of 40 minutes for 5 weeks, 3 times a
      week. An initial evaluation is applied with QUEST, ABILHAND-Kids, and MACS, which are
      re-evaluated at 3 and 6 months.

      Hypothesis: Armeo spring robotic therapy will obtain better results than conventional
      occupational therapy in relation to the functionality of the upper limb at the level of
      manipulative function, quality of movement of the limb and the performance of daily
      activities.

      Expected results: The results of the QUEST and ABILHAND-Kids dimensions assessed before,
      after and at follow-up will be the primary outcome. The presence of adverse effects will
      correspond to secondary outcome.

      Benefit and limitations: Direct social contribution for patient's rehabilitation by using
      technology and a contribution to research to update scientific evidence. Possible limitations
      could be presence of adverse effects and poor adherence to treatment.
    

Detailed description: 
      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.
    

Intervention name(s): Armeo spring; Occupational Therapy
Intervention type(s): Device; Other
Intervention description(s): Armeo spring is an exoskeleton that allows intensive therapy aimed at upper extremity tasks, which can be regulated according to the anthropometric measurements of the child and the objective of the session. The software contains an extensive library of game-like exercises that are run in a motivating and informative virtual reality training environment, clearly showing the functional task to be performed through immediate feedback in a 3D work space.; This treatment includes passive stretching exercises, weight bearing, stimulation of protective reactions, muscle strengthening exercises and different types of motivating bimanual games, favoring reaching, grasping, exploration and manipulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The type of study to be developed corresponds to a parallel group randomized clinical trial (RCT) with a superiority study framework, as it seeks to compare the effectiveness of Armeo spring robotic therapy versus conventional occupational therapy in terms of the functionality of the upper limb of children with hemiparesis infiltrated simultaneously with BTA. The trial phase corresponds to phase III.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Unilateral Cerebral Palsy; Upper extremity function; Armeo spring; Occupational Therapy.