Clinical trial NCT03552614: Movement Improvement After Paediatric Armeo®Spring Rehabilitation
Official title: Movement Velocity and Fluidity Improve After Armeo®Spring Rehabilitation in Children Affected by Acquired and Congenital Brain Diseases: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acquired Brain Injury
Cerebral Palsy
Keywords: robot-assisted rehabilitation
Armeo®Spring
quantitative assessment
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
Collaborators: name: Sol et Salus Hospital, Rimini, Italy
First posted: 2018-06-12
Enrollment: 43
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neurophysiatric care unit

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Quality of Upper Extremities Skills Test (QUEST)
timeFrame: baseline, after 1 month
measure: Melbourne Assessment of Unilateral Upper Limb Function
timeFrame: baseline, after 1 month
measure: Hand Path Ratio (HPR)
timeFrame: baseline, after two weeks, after 1 month
measure: horOS and verOS
timeFrame: baseline, after two weeks, after 1 month
measure: velocity
timeFrame: baseline, after two weeks, after 1 month
measure: number of velocity peaks
timeFrame: baseline, after two weeks, after 1 month
measure: normalized jerk
timeFrame: baseline, after two weeks, after 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: Scientific Institute IRCCS E. Medea
state: Lecco
Study officials:
affiliation: Scientific Institute IRCCS E. Medea
name: Emilia Biffi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.