CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 43 enrolled
Drug / intervention
Upper limb robot-assisted rehabilitation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03552614
NCT03552614N/ACompleted

Movement Velocity and Fluidity Improve After Armeo®Spring Rehabilitation in Children Affected by Acquired and Congenital Brain Diseases: an Observational Study

IRCCS Eugenio Medea·observational·Posted Jun 12, 2018·Updated Feb 26, 2020

In Brief

An observational study evaluating Upper limb robot-assisted rehabilitation and physiotherapy for Acquired Brain Injury and Cerebral Palsy. Completed, enrolled 43 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJun 12, 2018
Enrollment StartApr 20, 2018
Primary CompletionMay 20, 2018
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 8.1 years ago

Interventions

Upper limb robot-assisted rehabilitationdevice

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.

physiotherapyother

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.