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Movement Improvement After Paediatric Armeo®Spring Rehabilitation

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ClinicalTrials.gov Identifier: NCT03552614
Recruitment Status : Completed
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Collaborator:
Sol et Salus Hospital, Rimini, Italy
Information provided by (Responsible Party):
Emilia Biffi, 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.


Condition or disease Intervention/treatment
Acquired Brain Injury Cerebral Palsy Device: Upper limb robot-assisted rehabilitation Other: physiotherapy

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Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Movement Velocity and Fluidity Improve After Armeo®Spring Rehabilitation in Children Affected by Acquired and Congenital Brain Diseases: an Observational Study
Actual Study Start Date : April 20, 2018
Actual Primary Completion Date : May 20, 2018
Actual Study Completion Date : May 20, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
children with brain damage
Patients undergo physiotherapy + Upper limb robot-assisted rehabilitation
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 Name: Armeo Spring

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.




Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. velocity [ Time Frame: baseline, after two weeks, after 1 month ]
    the mean and the maximum velocity of the 3D end-point trajectory (cm/s)

  6. 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

  7. 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



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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neurophysiatric care unit
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552614


Locations
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Italy
Scientific Institute IRCCS E. Medea
Bosisio Parini, Lecco, Italy, 23842
Sponsors and Collaborators
IRCCS Eugenio Medea
Sol et Salus Hospital, Rimini, Italy
Investigators
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Principal Investigator: Emilia Biffi, PhD Scientific Institute IRCCS E. Medea

Publications:
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Responsible Party: Emilia Biffi, Post doc research fellow, IRCCS Eugenio Medea
ClinicalTrials.gov Identifier: NCT03552614     History of Changes
Other Study ID Numbers: 05/2018-Oss
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emilia Biffi, IRCCS Eugenio Medea:
robot-assisted rehabilitation
Armeo®Spring
quantitative assessment
Additional relevant MeSH terms:
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Brain Injuries
Cerebral Palsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Damage, Chronic