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临床试验/NCT03552614
NCT03552614已完成不适用

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

IRCCS Eugenio Medea1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2018年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
试验地点
1
主要终点
Quality of Upper Extremities Skills Test (QUEST)

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Quality of Upper Extremities Skills Test (QUEST)

时间窗: 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.

Melbourne Assessment of Unilateral Upper Limb Function

时间窗: 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

Hand Path Ratio (HPR)

时间窗: 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

horOS and verOS

时间窗: 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

velocity

时间窗: baseline, after two weeks, after 1 month

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

number of velocity peaks

时间窗: 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

normalized jerk

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
IRCCS Eugenio Medea
申办方类型
Other
责任方
Sponsor

研究点 (1)

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