Movement Improvement After Paediatric Armeo®Spring Rehabilitation

Completed

• Conditions: Acquired Brain Injury; Cerebral Palsy
• Interventions: Device: Upper limb robot-assisted rehabilitation; Other: physiotherapy

• Registration Number: NCT03552614
• Lead Sponsor: IRCCS Eugenio Medea

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-20
• Primary Completion: 2018-05-20
• Study Completion: 2018-05-20
• Study First Submitted: 2018-05-30
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-06-12
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-25
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
children with brain damage	Upper limb robot-assisted rehabilitation	Patients undergo physiotherapy + Upper limb robot-assisted rehabilitation
children with brain damage	physiotherapy	Patients undergo physiotherapy + Upper limb robot-assisted rehabilitation

Primary Outcome Measures

Name	Time	Method
number of velocity peaks	baseline, after two weeks, after 1 month	the number of peaks of the velocity profile. The lower is its value the smoother is the movement
normalized jerk	baseline, after two weeks, after 1 month	computed as the differentiation of the 3D end-point trajectory. The lower is its value the smoother is the movement
Quality of Upper Extremities Skills Test (QUEST)	baseline, after 1 month	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.
Melbourne Assessment of Unilateral Upper Limb Function	baseline, after 1 month	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
Hand Path Ratio (HPR)	baseline, after two weeks, after 1 month	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
horOS and verOS	baseline, after two weeks, after 1 month	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
velocity	baseline, after two weeks, after 1 month	the mean and the maximum velocity of the 3D end-point trajectory (cm/s)

Trial Locations

Locations (1)

Scientific Institute IRCCS E. Medea; 🇮🇹 Bosisio Parini, Lecco, Italy