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临床试验/CTRI/2024/05/067363
CTRI/2024/05/067363尚未招募不适用

Usability Evaluation of Motorized Arm Support (MARS) for Robot-Assisted Upper-Limb Training

Christian Medical College Vellore1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
System Usability Scale

研究概览

简要总结

Injury to the brain caused by Stroke often results in weakness in the arm, which leads to difficulty in performing activities of daily living. It is possible to regain these functions by high-intensity therapy. One of the important techniques used in therapy is providing adaptive arm weight support. Existing passive devices for weight support, also used at home, are simple and inexpensive but do not have sensors that could make therapy fun and engaging through the concept of therapy by games. In addition, these devices are unable to automatically adapt weight support as the user recovers ability. Rehabilitation robots, on the other hand, address all these problems but are very expensive and complex for home settings. Thus, a simple, compact device is needed that enhances motivation through therapy by games with the potential for home therapy. Motorized Arm Support (MARS) is such a device being developed to satisfy these conditions. An important step in the development of the device after the technical developments is obtaining feedback about the device’s usability for performing different types of arm training from clinicians, therapists, and stroke survivors and making suitable modifications to the device.

 Objectives

To understand clinical expectations of a rehabilitation robot that provides arm weight support from clinicians and stroke survivors.

 Methods:

After the preliminary version of MARS is developed, it is shown to clinicians to understand the clinical usefulness of its features (Part 1). Suggestions are also obtained for new features that could be added to MARS. Based on the feedback, design modifications are made to the device and usability is evaluated using the system usability scale by testing the device with clinicians (Part 2a) and stroke survivors (Part 2b). The following section discuss Part 2b of the usability study with stroke survivors

Stroke survivors with weakness in the arm who:

a.      are above 18 years of age

b.     can understand instructions

c.      could perform small movements with robot support

are included in the study.

Patients with problems in the shoulder, such as pain, are excluded from the study. A therapist performs baseline assessments on stroke survivors, such as the Fugl-Meyer Assessment (FMA), and the Box and Block Test (BBT), to understand the impact of Stroke. Horizontal work area and grip strength are also measured to understand the usefulness of arm weight support in increasing the range of motion and grip strength, respectively. Clinicians and stroke survivors evaluate the usability of MARS using the System Usability Scale. Intervention includes moving the arm to play games and performing ADL activities in virtual or real life with arm weight support provided by the robot. Hand grasp is also trained for subjects with hand functions.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Stroke survivor prescribed for upper limb therapy.
  • MoCA greater than 26/30 Minimum 10 cm voluntary movement with weight support from MARS.

排除标准

  • Shoulder subluxation greater than 0 by fingerbreadth palpation method Pain in shoulder/elbow joints, visual analogue scale – VIS greater than 3/10.

结局指标

主要结局

System Usability Scale

时间窗: After a day or within a week from enrolment.

次要结局

  • Intrinsic Motivation Inventory (IMI)(After two therapy sessions)
  • Fugl Meyer Assessment(Baseline)
  • Box and Block Test(Baseline)
  • Work Area with 0%, 50% and 100% weight support(Baseline)
  • Grip strength with 0%, 50% and 100% weight support(Baseline)

研究者

发起方
Christian Medical College Vellore
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Sivakumar Balasubramanian

Christian Medical College Vellore

研究点 (1)

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