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Using Sensorimotor Reorganization Following Upper Limb Amputation to Improve Prosthetic Control (REINVENT)

Amputation of an upper limb results in a disruption of the sensorimotor loop and a reorganization of the nervous system, leading to the emergence of a phantom limb and the adaptation of compensatory motor strategies. This project aims to leverage these phenomena (induced sensations, phantom mobility, and compensations) to improve control, sensory feedback, and the appropriation of prostheses, in order to reduce cognitive load and musculoskeletal disorders.

研究概览

研究类型

介入性

注册 (估计的)

50

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。

学习联系方式

研究联系人备份

学习地点

      • Nancy、法国、54000
        • 招聘中
        • Institut Régional de Médecine Physique et de Réadaptation, Filière Locomoteur
        • 首席研究员:
          • Amélie Touillet, Doctor PMR
        • 副研究员:
          • Jonathan Pierret, Head of the Unit
        • 副研究员:
          • Isabelle Loiret, Doctor PMR
        • 副研究员:
          • Pierrick Herbé, Doctor PMR
        • 副研究员:
          • Jean Paysant, MD, PhD PMR
      • Rennes、法国、35000
        • 招聘中
        • Fondation Saint-Hélier
        • 首席研究员:
          • Emilie Leblong, Doctor PMR
        • 副研究员:
          • Thomas Lambert, Doctor PMR
        • 副研究员:
          • Marie Chantrelle-Boucherit, Doctor PMR

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • people aged 18 or more
  • amputation or agenesis of one uper limb, above the wrist or higher
  • understanding of the French language and the ability to express onself in that language (for semi-structured interviews)
  • affiliation to a social security programm

Exclusion Criteria:

  • history of progressive psychiatric or neurological disorders or disorders with residual effects
  • pregnant or breastfeeding woman
  • minor
  • an adult under legal guardianship
  • pain influencing movement (trunk, residual limb, phantom limb, contralateral limb)

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:基础科学
  • 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
实验性的:Phantom-limb and motor compensation evaluation
The objective of this phase is to identify, from a population of individuals with upper limb amputations, a sufficient number of participants who experience non-painful phenomena related to their phantom limb (sensations, mobility, etc.) prior to the subsequent phases. This phase takes the form of a semi-structured individual interview conducted by one of the study investigators.
The objective of this phase is to study the phenomenon of induced phantom sensations in individuals who reported experiencing such sensations during the previous phase. This phase involves a systematic exploration of the areas of the residual limb whose stimulation induces non-painful phantom sensations, as well as the type of sensations thus induced.
The goal of this phase is to determine whether stimulation of the residual limb that induces sensations in the phantom limb can help people with lower-limb amputations use their prostheses more effectively.
The objective of this phase is to characterize the influence of voluntary movements of the residual limb on the myoelectric activity associated with phantom limb mobility. Myoelectric activity and cognitive load will be assessed
The objective of this phase is to evaluate the performance of a prosthetic control method based on phantom limb movement in individuals with upper limb amputations. The principle behind this method is to control the movements of the prosthesis using the corresponding movements of the phantom limb, by utilizing the myoelectric activity that can be measured on the residual limb during voluntary phantom limb movements.
The objective of this phase is to characterize and quantify the compensatory movements associated with the use of a conventional myoelectric upper limb prosthesis. The participant will perform the manipulation tasks defined in the SHAP method, as well as the clothespin displacement test.
The objective of this phase is to evaluate the performance of a prosthesis control method based on the compensatory movements associated with the use of an upper limb prosthesis. During this phase, participants will not use their personal prostheses but rather an experimental prosthesis developed by the investigators specifically for this study. The experimental prosthesis will be programmed to implement the control method based on compensatory movements, which is the focus of this evaluation.

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
Characterization of phantom limb
大体时间:Baseline (Phase 1 session) ; optional repeat assessment at 6 months
Semi-structured interview to elicit patients' descriptions of phantom sensations
Baseline (Phase 1 session) ; optional repeat assessment at 6 months

次要结果测量

结果测量
措施说明
大体时间
NASA TLX Score
大体时间:Administered at the end of each experimental sequence, up to 6 months
The cognitive load associated with the various tasks will be assessed. The higher the score, the greater the cognitive load.
Administered at the end of each experimental sequence, up to 6 months
Southampton Hand Assessment Procedure (SHAP)
大体时间:At each evaluation session, up to 6 month
A standardized, timed questionnaire-led assessment of pathological hand function. It evaluates overall hand function and dexterity through 26 tasks, including 12 abstract object manipulations and 14 activities of daily living (ADL). Tasks are timed to calculate an overall Index of Function (IoF) scored out of 100, where higher scores reflect better hand function.
At each evaluation session, up to 6 month
Clothespin Relocation Test (CRT)
大体时间:At each evaluation session, up to 6 months
A functional upper limb assessment measuring manual dexterity and proximal control. Participants are timed while transferring a set number of clothespins from a horizontal bar to a vertical bar (and/or vice versa) against varying spring resistances. Performance is measured by the total time taken (in seconds) to complete the task, where a shorter duration indicates better motor efficiency and coordination
At each evaluation session, up to 6 months

其他结果措施

结果测量
措施说明
大体时间
Mapping of induced sensations
大体时间:Baseline (Phase 2 session) and after the home-training period (up to 6 months)
Mapping the relationships between real members and ghost members
Baseline (Phase 2 session) and after the home-training period (up to 6 months)
Assessment of the effects of phantom sensation induction
大体时间:Day 1 (single Phase 3 session)
Whenever the participant controls the virtual hand, its movements (i.e., degree of opening and closing) will be recorded. The participant's performance will be measured by the rate of correctly identifying the stiffer object for each pair of objects presented.
Day 1 (single Phase 3 session)
Classification of myoelectric activity associated with phantom limb movements
大体时间:Day 1 (single Phase 4 session)
Classification of recorded myoelectric activity for residual and intact limbs
Day 1 (single Phase 4 session)

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。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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)

2026年4月15日

初级完成 (估计的)

2030年4月30日

研究完成 (估计的)

2030年4月30日

研究注册日期

首次提交

2026年5月21日

首先提交符合 QC 标准的

2026年6月18日

首次发布 (实际的)

2026年6月24日

研究记录更新

最后更新发布 (实际的)

2026年6月24日

上次提交的符合 QC 标准的更新

2026年6月18日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2026-A00233-48

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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