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

NCT04554238 | Completed DMC

• 1 other identifier: SDI2019026
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Palsy; Upper Extremity Paresis

Keywords

Unilateral Cerebral Palsy; Upper extremity function; Armeo spring; Occupational Therapy.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (2)

• Adherence

  Through study completion, an average of 7 months

• Adverse event

  Through study completion, an average of 7 months

Study Arms (2)

Armeo spring group

EXPERIMENTAL

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.

Device: Armeo spring

Occupational Therapy group

ACTIVE COMPARATOR

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.

Other: Occupational Therapy

Interventions

Armeo spring DEVICE

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.

Armeo spring group

Occupational Therapy OTHER

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.

Occupational Therapy group

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of Unilateral spastic cerebral palsy
• Botulinum toxin infiltration 3 weeks before start
• Manual Ability Classification scale in level I, II and III

You may not qualify if:

• 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

Sponsors & Collaborators

• Sociedad Pro Ayuda del Niño Lisiado: lead

Study Sites (1)

Ana Aburto Ojeda

Concepción, Bio Bio, Chile

Location

Related Publications (7)

• 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.

  PMID: 17370477 BACKGROUND

• 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.

  PMID: 22244966 BACKGROUND

• 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.

  PMID: 12370887 BACKGROUND

• 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.

  PMID: 3596065 BACKGROUND

• 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.

  PMID: 16780622 BACKGROUND

• 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.

  PMID: 29059068 RESULT

• 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.

  PMID: 25015650 RESULT

MeSH Terms

Conditions

Cerebral Palsy; Paresis

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 18, 2020
• Study Start: November 1, 2018
• Primary Completion: July 1, 2019
• Study Completion: July 30, 2019
• Last Updated: September 18, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)