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

Sociedad Pro Ayuda del Niño Lisiado

Status: Completed

Conditions: Upper Extremity Paresis; Cerebral Palsy

Treatments: Device: Armeo spring; Other: Occupational Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04554238

SDI2019026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 6 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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23 participants in 2 patient groups

Armeo spring group

Experimental group

Description:

Regarding masking, it is impossible for the treating occupational therapist to be unaware of the treatment to be carried out by the treated patient, just as it is impossible for the patient not to identify the treatment to which they access, therefore, this study is single-blind, considering only who performs the evaluations of the study will not know which group corresponds to the evaluated patient.

Treatment:

Device: Armeo spring

Occupational Therapy group

Active Comparator group

Description:

It consists of 5 weeks of intervention, with 3 treatment sessions per week, 40 minutes each time. The patient performs active exercises of the paretic upper limb: bimanual play activities, weight bearing, reaches in various planes of motion that favor shoulder flexion, elbow extension, forearm supination, and dissociated finger movements. In addition to passive mobilizations of the shoulder, elbow and wrist and tactile and proprioceptive sensory stimulation and the use of paretic limbs as support or carrying out prehensions.

Treatment:

Other: Occupational Therapy