Movement Improvement After Paediatric Armeo®Spring Rehabilitation

NCT03552614 | Completed

• 1 other identifier: 05/2018-Oss
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Brain Injury; Cerebral Palsy

Keywords

robot-assisted rehabilitation; Armeo®Spring; quantitative assessment

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• velocity

  the mean and the maximum velocity of the 3D end-point trajectory (cm/s)

  baseline, after two weeks, after 1 month

• 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

• 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

Study Arms (1)

children with brain damage

Patients undergo physiotherapy + Upper limb robot-assisted rehabilitation

Device: Upper limb robot-assisted rehabilitation; Other: physiotherapy

Interventions

Upper limb robot-assisted rehabilitation DEVICE

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.

Also known as: Armeo Spring

children with brain damage

physiotherapy OTHER

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.

children with brain damage

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Neurophysiatric care unit

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead
• Sol et Salus Hospital, Rimini, Italy: collaborator

Study Sites (1)

Scientific Institute IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

Location

Related Publications (5)

• 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.

  PMID: 19293759 BACKGROUND

• 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.

  PMID: 26554345 BACKGROUND

• 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.

  PMID: 24760936 BACKGROUND

• 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.

  PMID: 24037096 BACKGROUND

• 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.

  PMID: 27278277 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Cerebral Palsy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Damage, Chronic

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Emilia Biffi, PhD

  Scientific Institute IRCCS E. Medea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 12, 2018
• Study Start: April 20, 2018
• Primary Completion: May 20, 2018
• Study Completion: May 20, 2018
• Last Updated: February 26, 2020

Record last verified: 2020-02

Locations

IT (1)