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Completed

NCT Number: NCT03552614

Movement Improvement After Paediatric Armeo®Spring Rehabilitation

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.

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Key information

Conditions

Acquired Brain Injury Brain Damage, Chronic Brain Diseases Brain Injuries Central Nervous System Diseases Cerebral Palsy Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Scientific Institute IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Armeo Spring

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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

IRCCS Eugenio Medea

Other

Collaborators

  • Sol et Salus Hospital, Rimini, Italy

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 12, 2018
Registry last updated
Feb 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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