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Upper Limb Exosuit for Clinic Assistance

2021年11月3日 更新者:Tan Tock Seng Hospital

Smart Rehabilitation Exosuits for Clinic and Home Assistance

Aim is to do a feasibility and refinement trial to assess the safety and comfort of the robotic device and their preliminary effect on muscular activity during the performance of activities of daily living.

The study was carried out with 10 stroke participants who had to carry out a series of 10 functional tasks with and without the suit over 3 sessions.

The results are encouraging and show the potential of using wearable robotic devices in a clinical setting.

研究概览

详细说明

Each participant completed 3 ninety-minute long sessions at CART over the course of a week. All participants were closely supervised by 1 occupational therapist and 1 engineer involved in the development of the devices. In the first session, screening of the patient was performed, where the patient's demographics and clinical parameters were collected, including the grip strength of the affected hand measured by a hand dynamometer taking the mean of 2 attempts, and MOCA, FMA and MAS scores. Afterwards, a familiarisation phase was conducted, where the participant trialled the robotic devices to understand their mechanisms and learn how to use them. This phase also allowed the researchers to adjust the fitting of the exoskeletons and tuning the control algorithm of the elbow exoskeleton to the biomechanics of each user, in order to achieve best comfort and assistance.

The participants were instructed to perform a series of elbow/finger flexion and extension movements to understand how to control the exoskeletons. The participants also interacted with different objects (cup, cube, ball) to adjust the positioning of the anchor points in the glove to the position the participants felt most comfortable with. Once the optimised fitting of the devices was identified, the obtained parameters were stored, and the configuration of the devices was left unchanged for reuse in the next session.

In the 2 remaining sessions, participants performed a series of 10 functional tasks. The tasks were performed without assistance (NO-EXO condition) and with assistance (EXO condition) of the exoskeletons. The tasks were performed first in the unpowered condition to allow the participants to familiarise themselves with the tasks before performing them with the assistance of the devices.

The participants were instructed to start every attempt at a task from a position marked on the floor, and with their arms fully relaxed. This was to ensure that variability from unknown factors was minimised. The participants then awaited the instruction from the researchers to commence the task, given in the form of a spoken command triggered by the press of a button. The button was pressed again to signal the end of the task, defined by the following in order of priority: 1) participant decided to stop; 2) the participant dropped the object; 3) therapist decided to stop after deciding the participant was experiencing difficulties and further attempts would not contribute to a successful performance of the task; 4) task is successfully completed.

In addition to the performance of functional tasks, the standing horizontal fingertip reaching distance and the elbow ROM were measured using a measuring tape and a goniometer, respectively.

At the end of the 3rd session, the participants were asked to fill up a questionnaire to provide their subjective feedback regarding comfort, ergonomics, ease of use, overall clinical benefit and user satisfaction.

研究类型

介入性

注册 (实际的)

10

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Singapore、新加坡、308433
        • Tan Tock Seng Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 至 80年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patient with motor deficit(s) due to stroke as diagnosed by CT or MRI, who are attending outpatient rehabilitation services at TTSH Rehabilitation Centre and Centre for Advanced Rehabilitation Therapeutics;
  • Patient with first ever clinical stroke (confirmed on brain imaging);
  • Post stroke of at least 3 months with stable neurological status;
  • Age between 21 to 80 years, inclusive;
  • Hemiplegic pattern and shoulder abduction Medical Research Council motor power > 2/5;
  • Able to give and sign informed consent at research site;
  • Montreal Cognitive Assessment >= 22/30.

Exclusion Criteria:

  • Patient with severe cognitive, perceptual (include hemi-neglect), and/or emotional-behavioural issues that preclude participation;
  • Experiencing moderate to severe levels of pain (visual numeric pain rating scale > 5);
  • Has unstable or terminal medical conditions which may affect participation (e.g. unresolved sepsis, postural hypotension, end stage renal failure) or anticipated life expectancy of < 1 year due to malignancy or neurodegenerative disorder;
  • Non-stroke related causes of arm motor impairment;
  • Local factors which may be worsened by arm therapy or device interface: spasticity of MAS > 3, unhealed skin wounds/rashes, shoulder pain visual analog scale > 5/10, active fractures or arthritis or fixed flexion contractures of shoulder, elbow, wrist or fingers incompatible with device interface;
  • Inability to tolerate 90 minutes of therapy session;
  • Pregnancy or breast feeding;
  • Detectable sensory impairment of affected limb---hemianesthesia to sharp pain.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:设备可行性
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Refinement and Feasibility Trial

It is intra - individual comparison study

Arm 1: participant wore the custom-made upper limb exosuit and hand exoskeleton to perform the series of tasks Arm 0: participant perform the same tasks without the custom-made upper limb exosuit and hand exoskeleton.

Participants go through 3 90-min sessions in a clinic setting and perform a series of functional tasks adapted from motor activity log and bilateral upper limb tasks with and without the device.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Assessment of the elbow module by self-reported evaluation via questionnaire
大体时间:End of the 3rd session, median duration of 5 days from baseline
Patient self-reported outcome of the ease of use, ranked from 1 to 5, 5 being the easiest and 1 being the least easy.
End of the 3rd session, median duration of 5 days from baseline
Assessment of the hand module by self-reported evaluation via questionnaire
大体时间:End of the 3rd session, median duration of 5 days from baseline
Patient self-reported outcome of the ease of use, ranked from 1 to 5, 5 being the easiest and 1 being the least easy.
End of the 3rd session, median duration of 5 days from baseline
Successful completion of tasks (without intervention)
大体时间:At 2nd session, median time of 2 days from baseline
The success of the tasks without the assistance of the exoskeletons was evaluated by the clinician.
At 2nd session, median time of 2 days from baseline
Successful completion of tasks (with intervention)
大体时间:At 3rd session, median time of 5 days from baseline
The success of the tasks with the assistance of the exoskeletons was evaluated by the clinician.
At 3rd session, median time of 5 days from baseline

次要结果测量

结果测量
措施说明
大体时间
Upper limb angular trajectory (without intervention)
大体时间:Average over the 2nd session, median time of 2 days from baseline
The upper limb angular trajectories while not wearing the exoskeletons were measured via Inertial Measurement Units (IMUs) to investigate changes in movements of the elbow and shoulder joints.
Average over the 2nd session, median time of 2 days from baseline
Upper limb angular trajectory (with intervention)
大体时间:Average over the 3rd session, median time of 5 days from baseline
The upper limb angular trajectories while wearing the exoskeletons were measured via Inertial Measurement Units (IMUs) to investigate changes in movements of the elbow and shoulder joints.
Average over the 3rd session, median time of 5 days from baseline
Muscular synergies (without intervention)
大体时间:Average over the 2nd session, median time of 2 days from baseline
The muscular synergies of the users while not wearing the exoskeletons were measured by calculating Pearson's correlation coefficient between muscles.
Average over the 2nd session, median time of 2 days from baseline
Muscular synergies (with intervention)
大体时间:Average over the 3rd session, median time of 5 days from baseline
The muscular synergies of the users while wearing the exoskeletons were measured by calculating Pearson's correlation coefficient between muscles.
Average over the 3rd session, median time of 5 days from baseline
Muscular effort (without intervention)
大体时间:Average over the 2nd session, median time of 2 days from baseline
The muscular efforts of the users while not wearing the exoskeletons were measured by surface electromyographic sensors (sEMG), and normalised against the maximum voluntary contraction (MVC) value obtained at the beginning of the session.
Average over the 2nd session, median time of 2 days from baseline
Muscular effort (with intervention)
大体时间:Average over the 3rd session, median time of 5 days from baseline
The muscular efforts of the users while wearing the exoskeletons were measured by surface electromyographic sensors (sEMG), and normalised against the maximum voluntary contraction (MVC) value obtained at the beginning of the session.
Average over the 3rd session, median time of 5 days from baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年3月23日

初级完成 (实际的)

2020年10月31日

研究完成 (实际的)

2020年10月31日

研究注册日期

首次提交

2021年9月30日

首先提交符合 QC 标准的

2021年11月3日

首次发布 (实际的)

2021年11月11日

研究记录更新

最后更新发布 (实际的)

2021年11月11日

上次提交的符合 QC 标准的更新

2021年11月3日

最后验证

2021年11月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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