Cerebral Palsy Clinical Trial
Official title:
Effectiveness of Armeo Spring Robotic Therapy in the Function of the Upper Limb of Children With Unilateral Spastic Cerebral Palsy Infiltrated With Botulinum Toxin: Single-blind, Parallel Group Randomized Clinical Trial
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.
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.
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