- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03552614
Movement Improvement After Paediatric Armeo®Spring Rehabilitation
Movement Velocity and Fluidity Improve After Armeo®Spring Rehabilitation in Children Affected by Acquired and Congenital Brain Diseases: an Observational Study
Children with acquired and congenital brain lesions (namely, cerebral palsy, CP, and acquired brain injury, ABI) may exhibit upper limb impairment, with consequent limitations in their daily living activities.
In recent years, robotic rehabilitation has become an important tool to promote functional recovery in patients with CP and ABI, thanks to its ability to promote high intensity, repetitive, engaging training. Moreover, it has additional advantages that can contribute to the understanding of the effectiveness of these devices in motor learning and recovery. It has indeed higher resolution and inter -rater and intra-rater reliability with respect to standard assessment methods (i.e. clinical scales). Furthermore, it is able to provide a quantitative evaluation of patients' movement during treatments instead of relying exclusively on qualitative observation. Recently, Merlo and co-workers (Sol et Salus, Rimini, Italy) developed and validated a tool to extract indices of accuracy, velocity and smoothness from the analysis of 3D trajectories of the end point of the robotic exoskeleton Armeo®Spring (Hocoma, CH).
The primary aim of the study is to retrospectively investigate the effectiveness of robot-assisted upper limb rehabilitation in children affected by congenital and acquired brain damages by means of funcional scales and quantitative assessment of movement performance (accuracy, velocity and smoothness).
Patients affected by acquired or congenital brain disease are enrolled. The inclusion criteria are: age between 5 and 18; the ability to handle objects in daily life within levels I, II, and III, according to the Manual Ability Classification System (MACS); the ability to understand and follow test instructions. Conversely, the exclusion criteria are: severe muscle contracture and/or spasticity, a diagnosis of severe learning disabilities or behavioral problems and visual or hearing difficulties that would impact on function and participation.
Participants undergo the standard intervention protocol followed at the IRCCS E. Medea. It is composed by 20 sessions with Armeo®Spring and 20 sessions of physiotherapy, within 1 month. Patients are evaluated before (T0) and after (T1) the intervention with the Quality of Upper Extremities Skills Test (QUEST) and the Melbourne Assessment of Unilateral Upper Limb Function. During the first, tenth and last training session, patients executed the "Vertical Capture" exergame, which assess patient's functional level during a task that involves elbow flex-extension and shoulder flex- extension and abd-adduction. From these evaluation sessions, quantitative indices of movement performance (precision, velocity and smoothness) are extracted.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Lecco
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Bosisio Parini, Lecco, Italy, 23842
- Scientific Institute IRCCS E. Medea
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- the ability to handle objects in daily life within levels I, II, and III, according to the Manual Ability Classification System (MACS);
- the ability to understand and follow test instructions.
Exclusion Criteria:
- severe muscle spasticity and/or contracture,
- diagnosis of severe learning disabilities or behavioral problems
- visual or hearing difficulties that would impact on function and participation
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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children with brain damage
Patients undergo physiotherapy + Upper limb robot-assisted rehabilitation
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Upper limb robot-assisted rehabilitation is performed with Armeo®Spring. It is a passive exoskeleton with five degrees of freedom that guarantees passive arm weight support with springs. The treatment was composed by 45 minutes of robotic training (5 times a week for 4 weeks) during which patients performed a customized pull of exergames.
Other Names:
Patients undergo 45-minute treatment sessions 5 times a week for 4 weeks of physiotherapy, focused on gross and fine motor ability to promote independence in daily activities, and it is customized on patients' need.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Quality of Upper Extremities Skills Test (QUEST)
Time Frame: baseline, after 1 month
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The QUEST is an internationally-validated scale that measures dissociated movement, grasp, weight-bearing and protective extension abilities in children with upper extremity movement disorders.
The total score is the average of these four domain scores, with higher scores representing a better quality of movement.
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baseline, after 1 month
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Melbourne Assessment of Unilateral Upper Limb Function
Time Frame: baseline, after 1 month
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The Melbourne Assessment is a test that scores the quality of unilateral upper-limb motor function based on items involving reach, grasp, release and manipulation in neurologically impaired children
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baseline, after 1 month
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Hand Path Ratio (HPR)
Time Frame: baseline, after two weeks, after 1 month
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ratio between the pathway of the end effector and the straight trajectory between the initial and final positions of the end effector; the score is 100% for straight movements while it increases when curved trajectories are performed
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baseline, after two weeks, after 1 month
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horOS and verOS
Time Frame: baseline, after two weeks, after 1 month
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the horizontal and vertical overshooting of the movement (in cm) with respect to the target.
It is a measure of the precision of the movement
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baseline, after two weeks, after 1 month
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velocity
Time Frame: baseline, after two weeks, after 1 month
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the mean and the maximum velocity of the 3D end-point trajectory (cm/s)
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baseline, after two weeks, after 1 month
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number of velocity peaks
Time Frame: baseline, after two weeks, after 1 month
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the number of peaks of the velocity profile.
The lower is its value the smoother is the movement
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baseline, after two weeks, after 1 month
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normalized jerk
Time Frame: baseline, after two weeks, after 1 month
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computed as the differentiation of the 3D end-point trajectory.
The lower is its value the smoother is the movement
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baseline, after two weeks, after 1 month
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Emilia Biffi, Phd, Scientific Institute IRCCS E. Medea
Publications and helpful links
General Publications
- Frascarelli F, Masia L, Di Rosa G, Cappa P, Petrarca M, Castelli E, Krebs HI. The impact of robotic rehabilitation in children with acquired or congenital movement disorders. Eur J Phys Rehabil Med. 2009 Mar;45(1):135-41.
- Turconi AC, Biffi E, Maghini C, Peri E, Servodio Iammarone F, Gagliardi C. Can new technologies improve upper limb performance in grown-up diplegic children? Eur J Phys Rehabil Med. 2016 Oct;52(5):672-681. Epub 2015 Nov 10.
- Colombo R, Cusmano I, Sterpi I, Mazzone A, Delconte C, Pisano F. Test-retest reliability of robotic assessment measures for the evaluation of upper limb recovery. IEEE Trans Neural Syst Rehabil Eng. 2014 Sep;22(5):1020-9. doi: 10.1109/TNSRE.2014.2306571. Epub 2014 Feb 20.
- Merlo A, Longhi M, Giannotti E, Prati P, Giacobbi M, Ruscelli E, Mancini A, Ottaviani M, Montanari L, Mazzoli D. Upper limb evaluation with robotic exoskeleton. Normative values for indices of accuracy, speed and smoothness. NeuroRehabilitation. 2013;33(4):523-30. doi: 10.3233/NRE-130998.
- Longhi M, Merlo A, Prati P, Giacobbi M, Mazzoli D. Instrumental indices for upper limb function assessment in stroke patients: a validation study. J Neuroeng Rehabil. 2016 Jun 8;13(1):52. doi: 10.1186/s12984-016-0163-4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05/2018-Oss
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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