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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04554238
• Other study ID #: SDI2019026
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: July 30, 2019

Study information

• Verified date: September 2020
• Source: Sociedad Pro Ayuda del Niño Lisiado
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 30, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis
• Paresis
• Upper Extremity Paresis

Intervention

Device:
• Armeo spring
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.

Other:
• Occupational Therapy
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.

Locations

Country	Name	City	State
Chile	Ana Aburto Ojeda	Concepción	Bio Bio

Sponsors (1)

Lead Sponsor	Collaborator
Sociedad Pro Ayuda del Niño Lisiado

Country where clinical trial is conducted

Chile, 

References & Publications (7)

Brown JK, van Rensburg F, Walsh G, Lakie M, Wright GW. A neurological study of hand function of hemiplegic children. Dev Med Child Neurol. 1987 Jun;29(3):287-304. — View Citation

El-Shamy SM. Efficacy of Armeo® Robotic Therapy Versus Conventional Therapy on Upper Limb Function in Children With Hemiplegic Cerebral Palsy. Am J Phys Med Rehabil. 2018 Mar;97(3):164-169. doi: 10.1097/PHM.0000000000000852. — View Citation

Eliasson AC, Krumlinde-Sundholm L, Rösblad B, Beckung E, Arner M, Ohrvall AM, Rosenbaum P. The Manual Ability Classification System (MACS) for children with cerebral palsy: scale development and evidence of validity and reliability. Dev Med Child Neurol. 2006 Jul;48(7):549-54. — View Citation

Gilliaux M, Renders A, Dispa D, Holvoet D, Sapin J, Dehez B, Detrembleur C, Lejeune TM, Stoquart G. Upper limb robot-assisted therapy in cerebral palsy: a single-blind randomized controlled trial. Neurorehabil Neural Repair. 2015 Feb;29(2):183-92. doi: 10 — View Citation

Klingels K, Demeyere I, Jaspers E, De Cock P, Molenaers G, Boyd R, Feys H. Upper limb impairments and their impact on activity measures in children with unilateral cerebral palsy. Eur J Paediatr Neurol. 2012 Sep;16(5):475-84. doi: 10.1016/j.ejpn.2011.12.008. Epub 2012 Jan 13. — View Citation

Pierce SR, Daly K, Gallagher KG, Gershkoff AM, Schaumburg SW. Constraint-induced therapy for a child with hemiplegic cerebral palsy: a case report. Arch Phys Med Rehabil. 2002 Oct;83(10):1462-3. — View Citation

Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14. Erratum in: Dev Med Child Neurol. 2007 Jun;49(6):480. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence	A treatment and session calendar will be prepared for each user, which will contain the total number of sessions that the patient must perform. At the end of the study, the percentage of adherence of the patient will be determined, calculating the number of sessions performed divided by the total number of scheduled therapies.	Through study completion, an average of 7 months
Other	Adverse event	The presence of adverse events in any of the study groups, such as pain, muscle fatigue, shoulder subluxation, among others, will be described.	Through study completion, an average of 7 months
Primary	Change from Baseline of "Quality of Upper Extremity Skills Test" score at 3 and 6 months post intervention	The Quality Upper Extremity Ability Test (QUEST) assesses the quality of upper extremity function in four domains: dissociated movements, grip, protective extension, and weight-bearing. It was designed to evaluate children with neuromotor dysfunction with spasticity and has been validated in children 18 to 8 years of age.; The scale presents a specific score for each dimension, which is added, and the final value that is transformed into a final percentage (0-100%). This percentage obtained is the one that is statistically analyzed, understanding that a higher percentage represents a better quality of movement.; The QUEST allows an evaluation of the quality of the movements of one and two hands in individuals with CP but does not allow an evaluation of the quality of life.	Before, after the interventions (3 months) and 6 months follow-up
Secondary	Change from Baseline of "Measure of manual ability for children with upper limb impairments; ABILHAND-kids" score at 3 and 6 months post intervention	The ABILHAND-Kids scale (measure of manual ability for children with upper limb impairments) consists of 21 items, mostly bimanual, rated by the parents. Parents report a better perception of their children's ability than the children themselves.; On this scale, each task had a numerical assignment according to the difficulty perceived by the father: easy = 1; difficult = 2 and impossible = 3, from which the average was obtained, which was statistically analyzed. It is considered that the decrease in the values corresponds to a perception of a greater number of activities that are easy to carry out by the child.; ABILHAND-Kids is responsive to detect changes after clinical trials using intensive training in children with unilateral CP. Therefore, this scale is potentially useful for assessing functional status.	Before, after the interventions (3 months) and 6 months follow-up