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Sponsor study identifier
interventional
23
1 country
1
Study Start
November 1, 2018
Actual (reported)Primary Completion
July 1, 2019
Actual (reported)Study Completion
July 30, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 30, 2019
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2018
Actual (reported)July 1, 2019
Actual (reported)July 30, 2019
Actual (reported)August 26, 2020
Actual (reported)September 18, 2020
Actual (reported)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
Change from Baseline of "Measure of manual ability for children with upper limb impairments; ABILHAND-kids" score at 3 and 6 months post intervention
Before, after the interventions (3 months) and 6 months follow-up
Adherence
Through study completion, an average of 7 months
Adverse event
Through study completion, an average of 7 months
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.
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.
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.
Ana Aburto Ojeda
Concepción, Biobio, Chile
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.
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.
23 participants (actual enrollment reported by the registry).
First Submitted
August 26, 2020
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.
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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. doi: 10.1053/apmr.2002.34832.
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. doi: 10.1111/j.1469-8749.1987.tb02482.x.
Eliasson AC, Krumlinde-Sundholm L, Rosblad 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. doi: 10.1017/S0012162206001162.
El-Shamy SM. Efficacy of Armeo(R) 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.
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: 10.1177/1545968314541172. Epub 2014 Jul 11.
First Posted
September 18, 2020
Study Start
November 1, 2018
Actual (reported)Primary Completion
July 1, 2019
Actual (reported)Study Completion
July 30, 2019
Actual (reported)Last Updated
September 18, 2020
Record last verified: 2020-09
Not, the information from the database will not be provided, since the tutors signed an authorization to participate and deliver the general results of the research, but authorization is not requested to deliver individual data.
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Source: ClinicalTrials.gov.
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