Movement Improvement After Paediatric Armeo®Spring Rehabilitation

February 25, 2020 updated by: IRCCS Eugenio Medea

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

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 Overview

Study Type

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Lecco
      • Bosisio Parini, Lecco, Italy, 23842
        • Scientific Institute IRCCS E. Medea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neurophysiatric care unit

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
children with brain damage
Patients undergo physiotherapy + 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 Names:
  • Armeo Spring
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Upper Extremities Skills Test (QUEST)
Time Frame: 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.
baseline, after 1 month
Melbourne Assessment of Unilateral Upper Limb Function
Time Frame: 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
baseline, after 1 month
Hand Path Ratio (HPR)
Time Frame: 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
baseline, after two weeks, after 1 month
horOS and verOS
Time Frame: 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
baseline, after two weeks, after 1 month
velocity
Time Frame: baseline, after two weeks, after 1 month
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
Time Frame: 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
baseline, after two weeks, after 1 month
normalized jerk
Time Frame: 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
baseline, after two weeks, after 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Emilia Biffi, Phd, Scientific Institute IRCCS E. Medea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2018

Primary Completion (Actual)

May 20, 2018

Study Completion (Actual)

May 20, 2018

Study Registration Dates

First Submitted

May 30, 2018

First Submitted That Met QC Criteria

May 30, 2018

First Posted (Actual)

June 12, 2018

Study Record Updates

Last Update Posted (Actual)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 25, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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