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在下肢截肢者行走过程中,全球和局部修饰的幻影感觉的用途是体感的反馈 (PhantomWalk)

Following lower-limb amputation, the loss of somatosensory information from the missing limb renders walking less automatic, more cognitively demanding, and often asymmetric, which can lead to secondary pathologies.

Hypothesis: This study is based on the hypothesis that phantom limb sensations (PLS), when coherent with the prosthetic device's movements and the phases of the gait cycle, can compensate for the loss of somatosensory feedback and thereby improve locomotion for individuals with amputation. It is further hypothesized that it is possible to artificially induce these coherent and useful sensations, notably through "referred sensations" elicited by stimulation of the residual limb (e.g., via the prosthetic socket).

Objectives: The project aims to:

  • Determine whether the natural presence of phantom limb sensations during walking impacts gait parameters.
  • Confirm in a larger patient population that modifications to the prosthetic socket can induce or enhance phantom sensations that are perceived as useful for walking.
  • Investigate whether these perceptual changes (induced or enhanced) are associated with objective, measurable improvements in gait quality.

研究概览

研究类型

介入性

注册 (估计的)

248

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

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

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Participants with amputations:

    • Major lower limb amputation
    • Understand and be able to express oneself in the French language (for semi-structured interviews)
    • Affiliated with a social security scheme
  • Asymptomatic volunteer participants:

    • No major surgery on the lower limbs for at least 3 years
    • No minor injury to the trunk, lower or upper limbs that could influence walking for at least 1 year
    • Understand and be able to express oneself in the French language
    • Affiliated with a social security scheme

Exclusion Criteria:

  • History of psychiatric disorders
  • Pregnant or breastfeeding woman
  • Minor
  • Adult subject to a legal protection measure
  • Person under guardianship or conservatorship
  • Person under a judicial protection order
  • Pain affecting walking (trunk, residual limb, phantom limb, contralateral limb)
  • Medical treatment incompatible with walking

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:卫生服务研究
  • 分配:非随机化
  • 介入模型:顺序分配
  • 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:Amputees w-o SF

People without fantom sensation during gait

Participants with unilateral amputations and a control group will undergo a comprehensive walking analysis. In a lab setting (on a treadmill or floor), their gait will be recorded using inertial sensors, EMG, force plates, and motion capture, while an EEG cap and a NASA-TLX questionnaire will assess cognitive load. Capable participants will also perform a walking test on a real-world outdoor course with varied terrain. The data will be analyzed to compare walking patterns between groups (amputees vs. controls, and amputees with vs. without phantom limbs). Finally, participants will describe any interactions they perceived between their phantom sensations and walking during the tests.

Participants reporting referred sensations in gait analysis phase will undergo further testing. The study will investigate whether prosthesis pressure or a specific socket interaction causes these sensations. A 3x3 cm grid will be drawn on the residual limb to systematically map referred sensations using various stimuli (brush, pressure tip, electrical stimulation). Participants will rate the intensity and describe the location of any resulting phantom sensations. This mapping will be repeated after 6 months to assess the stability of these sensations over time, with the ultimate goal of potentially using them to provide sensory feedback for prosthesis users. The session will last approximately 2 hours.

A semi-structured interview will be conducted to ask participants to describe their phantom limb sensations (type, location, intensity) under three conditions: without their prosthesis, while standing with it, and while walking with it. This aims to identify factors influencing these sensations. Additionally, a brief physical examination of the residual limb will be performed to see if touch in specific areas triggers any referred sensations.

实验性的:Amputees H-SF

People with phantom sensations who are caregivers

Participants with unilateral amputations and a control group will undergo a comprehensive walking analysis. In a lab setting (on a treadmill or floor), their gait will be recorded using inertial sensors, EMG, force plates, and motion capture, while an EEG cap and a NASA-TLX questionnaire will assess cognitive load. Capable participants will also perform a walking test on a real-world outdoor course with varied terrain. The data will be analyzed to compare walking patterns between groups (amputees vs. controls, and amputees with vs. without phantom limbs). Finally, participants will describe any interactions they perceived between their phantom sensations and walking during the tests.

Participants reporting referred sensations in gait analysis phase will undergo further testing. The study will investigate whether prosthesis pressure or a specific socket interaction causes these sensations. A 3x3 cm grid will be drawn on the residual limb to systematically map referred sensations using various stimuli (brush, pressure tip, electrical stimulation). Participants will rate the intensity and describe the location of any resulting phantom sensations. This mapping will be repeated after 6 months to assess the stability of these sensations over time, with the ultimate goal of potentially using them to provide sensory feedback for prosthesis users. The session will last approximately 2 hours.

A semi-structured interview will be conducted to ask participants to describe their phantom limb sensations (type, location, intensity) under three conditions: without their prosthesis, while standing with it, and while walking with it. This aims to identify factors influencing these sensations. Additionally, a brief physical examination of the residual limb will be performed to see if touch in specific areas triggers any referred sensations.

In 10 unilateral transfemoral amputees with stable induced phantom sensations, this phase evaluates how a personalized socket modification affects phantom sensations and walking. With the prosthetist, a localized thickness (e.g., silicone insert) is added inside the usual socket at the stable stimulation sites identified on the residual-limb map, after measuring socket pressure with a thin sensor array. Each participant is tested in two conditions in a fixed order: usual socket first, then modified socket. The order is not randomized because induced sensations may persist after the modification is removed. For each condition, gait is analyzed in the laboratory and on the ecological course (4 sessions; conditions no more than 4 weeks apart). Participants describe their sensations, rate cognitive load, effort and socket comfort, and indicate which condition is most helpful for walking.

实验性的:Control

Asymptomatic people

Participants with unilateral amputations and a control group will undergo a comprehensive walking analysis. In a lab setting (on a treadmill or floor), their gait will be recorded using inertial sensors, EMG, force plates, and motion capture, while an EEG cap and a NASA-TLX questionnaire will assess cognitive load. Capable participants will also perform a walking test on a real-world outdoor course with varied terrain. The data will be analyzed to compare walking patterns between groups (amputees vs. controls, and amputees with vs. without phantom limbs). Finally, participants will describe any interactions they perceived between their phantom sensations and walking during the tests.

实验性的:Amputees B-SF

People with bothersome phantom sensations

Participants with unilateral amputations and a control group will undergo a comprehensive walking analysis. In a lab setting (on a treadmill or floor), their gait will be recorded using inertial sensors, EMG, force plates, and motion capture, while an EEG cap and a NASA-TLX questionnaire will assess cognitive load. Capable participants will also perform a walking test on a real-world outdoor course with varied terrain. The data will be analyzed to compare walking patterns between groups (amputees vs. controls, and amputees with vs. without phantom limbs). Finally, participants will describe any interactions they perceived between their phantom sensations and walking during the tests.

Participants reporting referred sensations in gait analysis phase will undergo further testing. The study will investigate whether prosthesis pressure or a specific socket interaction causes these sensations. A 3x3 cm grid will be drawn on the residual limb to systematically map referred sensations using various stimuli (brush, pressure tip, electrical stimulation). Participants will rate the intensity and describe the location of any resulting phantom sensations. This mapping will be repeated after 6 months to assess the stability of these sensations over time, with the ultimate goal of potentially using them to provide sensory feedback for prosthesis users. The session will last approximately 2 hours.

A semi-structured interview will be conducted to ask participants to describe their phantom limb sensations (type, location, intensity) under three conditions: without their prosthesis, while standing with it, and while walking with it. This aims to identify factors influencing these sensations. Additionally, a brief physical examination of the residual limb will be performed to see if touch in specific areas triggers any referred sensations.

In 10 unilateral transfemoral amputees with stable induced phantom sensations, this phase evaluates how a personalized socket modification affects phantom sensations and walking. With the prosthetist, a localized thickness (e.g., silicone insert) is added inside the usual socket at the stable stimulation sites identified on the residual-limb map, after measuring socket pressure with a thin sensor array. Each participant is tested in two conditions in a fixed order: usual socket first, then modified socket. The order is not randomized because induced sensations may persist after the modification is removed. For each condition, gait is analyzed in the laboratory and on the ecological course (4 sessions; conditions no more than 4 weeks apart). Participants describe their sensations, rate cognitive load, effort and socket comfort, and indicate which condition is most helpful for walking.

实验性的:Amputees N-SF

People with neutral phantom sensations

Participants with unilateral amputations and a control group will undergo a comprehensive walking analysis. In a lab setting (on a treadmill or floor), their gait will be recorded using inertial sensors, EMG, force plates, and motion capture, while an EEG cap and a NASA-TLX questionnaire will assess cognitive load. Capable participants will also perform a walking test on a real-world outdoor course with varied terrain. The data will be analyzed to compare walking patterns between groups (amputees vs. controls, and amputees with vs. without phantom limbs). Finally, participants will describe any interactions they perceived between their phantom sensations and walking during the tests.

Participants reporting referred sensations in gait analysis phase will undergo further testing. The study will investigate whether prosthesis pressure or a specific socket interaction causes these sensations. A 3x3 cm grid will be drawn on the residual limb to systematically map referred sensations using various stimuli (brush, pressure tip, electrical stimulation). Participants will rate the intensity and describe the location of any resulting phantom sensations. This mapping will be repeated after 6 months to assess the stability of these sensations over time, with the ultimate goal of potentially using them to provide sensory feedback for prosthesis users. The session will last approximately 2 hours.

A semi-structured interview will be conducted to ask participants to describe their phantom limb sensations (type, location, intensity) under three conditions: without their prosthesis, while standing with it, and while walking with it. This aims to identify factors influencing these sensations. Additionally, a brief physical examination of the residual limb will be performed to see if touch in specific areas triggers any referred sensations.

In 10 unilateral transfemoral amputees with stable induced phantom sensations, this phase evaluates how a personalized socket modification affects phantom sensations and walking. With the prosthetist, a localized thickness (e.g., silicone insert) is added inside the usual socket at the stable stimulation sites identified on the residual-limb map, after measuring socket pressure with a thin sensor array. Each participant is tested in two conditions in a fixed order: usual socket first, then modified socket. The order is not randomized because induced sensations may persist after the modification is removed. For each condition, gait is analyzed in the laboratory and on the ecological course (4 sessions; conditions no more than 4 weeks apart). Participants describe their sensations, rate cognitive load, effort and socket comfort, and indicate which condition is most helpful for walking.

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
Prevalence of non-painful phantom sensations during walking
大体时间:The first day of the study

Proportion of amputee participants able to walk who report non-painful phantom sensations during walking, collected during a standardized semi-structured interview. Reported as a proportion with its exact (Clopper-Pearson) 95% confidence interval

The first day of the study
Double support time during level walking at self-selected speed
大体时间:The first day of the study for the control group and the second day of the study for participants with amputation

Double support time, defined as the sum of the initial and terminal double support periods of the prosthetic-limb gait cycle, expressed as a percentage of gait cycle duration (%). Measured by 3D motion analysis and force plates during level overground walking at self-selected speed in the laboratory (spontaneous condition).

The first day of the study for the control group and the second day of the study for participants with amputation
Within-participant difference in double support time between usual and modified socket
大体时间:Days 4 to 7 of the study

Difference in double support time (% of gait cycle, same definition and walking condition as Phase 2) between walking with the usual socket and walking with the socket modified by a focal thickness addition designed to induce phantom sensations, in transfemoral amputees. Conditions assessed in a fixed order (usual socket first). Reported as mean difference with 95% confidence interval.

Days 4 to 7 of the study

次要结果测量

结果测量
措施说明
大体时间
Walking pace under laboratory conditions
大体时间:The first day of the study for the control group and the second day of the study for participants with amputation

The number of steps per minute (steps/min) when walking at a comfortable speed. Measured using inertial measurement units or the Vicon system.

The first day of the study for the control group and the second day of the study for participants with amputation
Analysis of brain activity related to cognitive load during walking
大体时间:The second day of the study for participants with amputation

Electroencephalographic (EEG) activity will be recorded via a headset. Cognitive load will be quantified by analyzing the power ratio in specific frequency bands at the frontal electrodes.

The second day of the study for participants with amputation
Gait speed in ecological situation
大体时间:The first day of the study for the control group and the second day of the study for participants with amputation

The average walking speed (in m/s) measured using inertial measurement units and pressure soles (Loadsol) during a predefined outdoor route including various difficulties (stairs, slopes, etc.).

The first day of the study for the control group and the second day of the study for participants with amputation
Qualitative description of the interaction between phantom sensations and walking
大体时间:The second day of the study for participants with amputation

Participants' verbal descriptions of the nature of the interaction (facilitating, hindering, neutral), the evolution and characteristics of phantom sensations during walking will be collected via a structured interview at the end of the session. The data will be analyzed thematically.

The second day of the study for participants with amputation
Effect of focal stimulation on phantom sensations
大体时间:Day 3 of the study

For the subgroup of participants reporting interaction between sensations and focal stimulation after various stimulations using a rubber tip (pressure), a brush, and a needle. The change in sensation intensity (rated on a scale of 0 to 5). The result will be categorized as "increase," "decrease," or "no change."

Day 3 of the study
Change in perceived cognitive load (NASA-TLX score) during walking in an ecological setting
大体时间:Day 4 to 7 of the study

Perceived mental workload will be assessed using the NASA-TLX questionnaire immediately after each walking session. The total score will be compared between the four socket conditions.

Day 4 to 7 of the study
Evaluation of socket comfort
大体时间:Day 4 to 7 of the study

The overall comfort perceived for each condition will be assessed at the end of each session using a Numerical Rating Scale (NRS) ranging from 0 (very uncomfortable) to 10 (very comfortable). The average score will be compared between the four conditions.

Day 4 to 7 of the study
Assessment of mental workload during walking using the NASA-TLX questionnaire
大体时间:The first day of the study for the control group and the second day of the study for participants with amputation

The cognitive load perceived by the participant will be assessed using the NASA Task Load Index (NASA-TLX) self-report questionnaire. The total score, ranging from 0 to 100, will be calculated. A higher score indicates a greater perceived cognitive load.

The first day of the study for the control group and the second day of the study for participants with amputation
Qualitative description of the sensations reported for each socket condition
大体时间:Day 4 to 7 of the study

For each condition, a structured description of the sensations reported (type, location, intensity, perceived usefulness for walking) will be collected through an interview. The data will be analyzed thematically to compare the sensory experience.

Day 4 to 7 of the study
Change in phantom limb sensation intensity at 6 months for recent amputees
大体时间:The first day of the study and during the 6-month follow-up visit.

For the subgroup of participants with an amputation of less than 6 months at inclusion, the intensity of phantom sensations will be re-assessed using the 3-point ordinal scale.

The first day of the study and during the 6-month follow-up visit.
Walking speed under laboratory conditions
大体时间:The first day of the study for the control group and the second day of the study for participants with amputation

The participant's average walking speed, measured in meters per second (m/s). The measurement will be collected using inertial measurement units (IMUs) and/or a Vicon motion capture system while the participant walks on hard ground or on a treadmill at their self-selected speed.

The first day of the study for the control group and the second day of the study for participants with amputation
Step length symmetry index.
大体时间:The first day of the study for the control group and the second day of the study for participants with amputation

Gait symmetry will be calculated based on the stride length of the affected (or corresponding) limb and the healthy limb. The symmetry index is a unitless ratio (or percentage) that quantifies the difference between the two limbs. A value of 1 (or 100%) indicates perfect symmetry. Measured using inertial measurement units or the Vicon system.

The first day of the study for the control group and the second day of the study for participants with amputation
Surface area and intensity of induced phantom sensation maps
大体时间:2nd or 3rd day of the study depending on whether the participant with an amputation was included in phase 2 or not and during the 6-month follow-up visit.

For each type of stimulation, the number of 3×3 cm areas of the residual limb eliciting phantom sensations is counted and the total surface area (cm²) is calculated (number × 9). For each reactive area, the participant rates the intensity of the induced sensation on a three-level ordinal scale (weak, medium, strong).

2nd or 3rd day of the study depending on whether the participant with an amputation was included in phase 2 or not and during the 6-month follow-up visit.
Preferred socket condition
大体时间:Day 7 of the study

At the end of Phase 4, participants indicate which condition (usual socket or modified socket) they perceive as most facilitating for walking.

Day 7 of the study
Spatiotemporal gait parameters in ecological situation
大体时间:Days 4 to 7 to the study

Walking speed (m/s), cadence (steps/min) and step symmetry index measured with inertial sensors and pressure insoles during the predefined indoor/outdoor course, compared between the usual socket and the modified socket.

Days 4 to 7 to the study
Characterization of phantom limb sensations
大体时间:The first day of the study

Composite assessment of phantom limb sensations via a semi-structured interview: type of sensation, location, intensity (weak, medium, strong) and perceived influence on walking (helpful, neutral, disturbing).

The first day of the study
Step length
大体时间:The first day of the study for the control group and the second day of the study for participants with amputation

Step length (m) of the prosthetic and intact limbs during level walking at self-selected speed.

The first day of the study for the control group and the second day of the study for participants with amputation
stance and swing phase durations
大体时间:The first day of the study for the control group and the second day of the study for participants with amputation

Stance and swing phase durations of each limb, expressed as % of gait cycle.

The first day of the study for the control group and the second day of the study for participants with amputation
Functional Ambulation Performance Score (FAPS)
大体时间:The first day of the study for the control group and the second day of the study for participants with amputation

Composite score computed from spatiotemporal parameters, ranging from 30 (highly pathological gait) to 100 (healthy gait).

The first day of the study for the control group and the second day of the study for participants with amputation
Enhanced Gait Variability Index (EGVI)
大体时间:The first day of the study for the control group and the second day of the study for participants with amputation

Composite gait variability score computed from step-to-step spatiotemporal parameters; values between 95 and 105 indicate healthy variability.

The first day of the study for the control group and the second day of the study for participants with amputation
Raw NASA-TLX score (RTLX)
大体时间:The first day of the study for the control group and the second day of the study for participants with amputation

Perceived cognitive workload during walking, computed as the mean of the six NASA-TLX dimensions, each rated 0-10 (higher = higher workload).

The first day of the study for the control group and the second day of the study for participants with amputation
Perceived exertion (Borg CR10)
大体时间:The first day of the study for the control group and the second day of the study for participants with amputation

Borg CR10 score (0-10; higher = greater exertion), collected after each walking condition.

The first day of the study for the control group and the second day of the study for participants with amputation
Perceived interaction between phantom sensations and walking
大体时间:the second day of the study for participants with amputation

Visual analog scale from -5 (very disturbing) to +5 (very helpful), completed by participants with phantom sensations after each walking condition; analyzed as a continuous variable

the second day of the study for participants with amputation

其他结果措施

结果测量
措施说明
大体时间
Maximum vertical reaction force during walking.
大体时间:The first day of the study for the control group and the second day of the study for participants with amputation

The maximum force exerted on the ground with each step, measured in Newtons (N) or as a percentage of body weight (%BW). The measurement will be taken using force platforms (AMTI), pressure insoles (Loadsol), or an instrumented mat (Zeno).

The first day of the study for the control group and the second day of the study for participants with amputation

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)

2024年9月16日

初级完成 (估计的)

2028年9月30日

研究完成 (估计的)

2030年9月30日

研究注册日期

首次提交

2025年8月21日

首先提交符合 QC 标准的

2025年9月23日

首次发布 (实际的)

2025年9月25日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年10月29日

最后验证

2026年10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

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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