Movement Improvement After Paediatric Armeo®Spring Rehabilitation

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03552614
• Other study ID #: 05/2018-Oss
• Status: Completed
• Start date: April 20, 2018
• Est. completion date: May 20, 2018

Study information

• Verified date: February 2020
• Source: IRCCS Eugenio Medea
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 20, 2018
• Est. primary completion date: May 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Cerebral Palsy

Intervention

Device:
• Upper limb robot-assisted rehabilitation
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:
• physiotherapy
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.

Locations

Country	Name	City	State
Italy	Scientific Institute IRCCS E. Medea	Bosisio Parini	Lecco

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS Eugenio Medea	Sol et Salus Hospital, Rimini, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

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