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下肢切断者での歩行中の体性感覚フィードバックとして、補綴ソケットのグローバルおよび局所的な修正によって誘発されるファントム感覚の使用 (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.

調査の概要

研究の種類

介入

入学 (推定)

248

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ヘルスサービス研究
  • 割り当て:非ランダム化
  • 介入モデル:順次割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

実験的: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.

実験的: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.

実験的: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.

実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Prevalence of non-painful phantom sensations during walking
時間枠: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
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Walking pace under laboratory conditions
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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.
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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)
時間枠: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
時間枠: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

その他の成果指標

結果測定
メジャーの説明
時間枠
Maximum vertical reaction force during walking.
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年9月16日

一次修了 (推定)

2028年9月30日

研究の完了 (推定)

2030年9月30日

試験登録日

最初に提出

2025年8月21日

QC基準を満たした最初の提出物

2025年9月23日

最初の投稿 (実際)

2025年9月25日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月3日

QC基準を満たした最後の更新が送信されました

2026年10月29日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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